Difference between revisions of "Non-small cell lung cancer, squamous"
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=Neoadjuvant therapy= | =Neoadjuvant therapy= | ||
==Cisplatin & Gemcitabine (GC) {{#subobject:uuhz8q|Regimen=1}}== | ==Cisplatin & Gemcitabine (GC) {{#subobject:uuhz8q|Regimen=1}}== | ||
− | |||
GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:1yjxx7|Variant=1}}=== | ===Regimen {{#subobject:1yjxx7|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*CheckMate 816: No sensitizing EGFR or ALK mutations | *CheckMate 816: No sensitizing EGFR or ALK mutations | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Gemcitabine (Gemzar)]] 1000 or 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 or 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycle for 3 cycles''' | '''21-day cycle for 3 cycles''' | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*[[Surgery#Surgical_resection|Complete resection]] | *[[Surgery#Surgical_resection|Complete resection]] | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] NCT02998528 | #'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] NCT02998528 | ||
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==Cisplatin & Gemcitabine (GC) & Nivolumab {{#subobject:cij9op|Regimen=1}}== | ==Cisplatin & Gemcitabine (GC) & Nivolumab {{#subobject:cij9op|Regimen=1}}== | ||
− | |||
GC & Nivolumab: '''<u>G</u>'''emcitabine, '''<u>C</u>'''isplatin, Nivolumab | GC & Nivolumab: '''<u>G</u>'''emcitabine, '''<u>C</u>'''isplatin, Nivolumab | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:ug8z0c|Variant=1}}=== | ===Regimen {{#subobject:ug8z0c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|} | |} | ||
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*CheckMate 816: No sensitizing EGFR or ALK mutations | *CheckMate 816: No sensitizing EGFR or ALK mutations | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Gemcitabine (Gemzar)]] 1000 or 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 or 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Nivolumab (Opdivo)]] 360 mg IV once on day 1 | *[[Nivolumab (Opdivo)]] 360 mg IV once on day 1 | ||
− | |||
'''21-day cycle for 3 cycles''' | '''21-day cycle for 3 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*[[Surgery#Surgical_resection|Complete resection]], then adjuvant therapy | *[[Surgery#Surgical_resection|Complete resection]], then adjuvant therapy | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] NCT02998528 | #'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] NCT02998528 | ||
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=Adjuvant therapy= | =Adjuvant therapy= | ||
==Cisplatin & Gemcitabine (GC) {{#subobject:289ea6|Regimen=1}}== | ==Cisplatin & Gemcitabine (GC) {{#subobject:289ea6|Regimen=1}}== | ||
− | |||
GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:88hb4c|Variant=1}}=== | ===Regimen {{#subobject:88hb4c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | |||
*Complete R0 [[Surgery#Lung_cancer_surgery|resection]], within 6 weeks | *Complete R0 [[Surgery#Lung_cancer_surgery|resection]], within 6 weeks | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Gemcitabine (Gemzar)]] 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1250 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
− | |||
'''21-day cycle for 4 cycles''' | '''21-day cycle for 4 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#'''NVALT-8:''' Groen HJM, van der Heijden EHFM, Klinkenberg TJ, Biesma B, Aerts J, Verhagen A, Kloosterziel C, Pieterman R, van den Borne B, Smit HJM, Hoekstra O, Schramel FMNH, van der Noort V, van Tinteren H, Smit EF, Dingemans AC; NVALT Study Group. Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study. Br J Cancer. 2019 Aug;121(5):372-377. Epub 2019 Jul 24. [https://www.nature.com/articles/s41416-019-0533-3 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31337877 PubMed] NTR1250/1217 | #'''NVALT-8:''' Groen HJM, van der Heijden EHFM, Klinkenberg TJ, Biesma B, Aerts J, Verhagen A, Kloosterziel C, Pieterman R, van den Borne B, Smit HJM, Hoekstra O, Schramel FMNH, van der Noort V, van Tinteren H, Smit EF, Dingemans AC; NVALT Study Group. Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study. Br J Cancer. 2019 Aug;121(5):372-377. Epub 2019 Jul 24. [https://www.nature.com/articles/s41416-019-0533-3 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31337877 PubMed] NTR1250/1217 | ||
− | |||
=Advanced or metastatic disease, first-line= | =Advanced or metastatic disease, first-line= | ||
==Atezolizumab monotherapy {{#subobject:utug94|Regimen=1}}== | ==Atezolizumab monotherapy {{#subobject:utug94|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen {{#subobject:1ubzd21|Variant=1}}=== | ===Regimen {{#subobject:1ubzd21|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|} | |} | ||
''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.'' | ''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.'' | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*PD-L1 expression on at least 1% of tumor cells or tumor-infiltrating immune cells covering at least 1% of the tumor area as determined by the SP142 assay | *PD-L1 expression on at least 1% of tumor cells or tumor-infiltrating immune cells covering at least 1% of the tumor area as determined by the SP142 assay | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1 | *[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
<!-- #'''Abstract:''' D. Spigel, F. de Marinis, G. Giaccone, N. Reinmuth, A. Vergnenegre, C.H. Barrios, M. Morise, E. Felip, Z.G. Andric, S. Geater, M. Özgüroğlu, S. Mocci, M. McCleland, I. Enquist, K.M. Komatsubara, Y. Deng, H. Kuriki, X. Wen, J. Jassem, R.S. Herbst, LBA78 - IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Ann Oncology, 2019.Oct: 30(5):915. [https://www.sciencedirect.com/science/article/pii/S0923753419603595 link to abstract] --> | <!-- #'''Abstract:''' D. Spigel, F. de Marinis, G. Giaccone, N. Reinmuth, A. Vergnenegre, C.H. Barrios, M. Morise, E. Felip, Z.G. Andric, S. Geater, M. Özgüroğlu, S. Mocci, M. McCleland, I. Enquist, K.M. Komatsubara, Y. Deng, H. Kuriki, X. Wen, J. Jassem, R.S. Herbst, LBA78 - IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Ann Oncology, 2019.Oct: 30(5):915. [https://www.sciencedirect.com/science/article/pii/S0923753419603595 link to abstract] --> | ||
#'''IMpower110:''' Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. [https://doi.org/10.1056/nejmoa1917346 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32997907/ PubMed] NCT02409342 | #'''IMpower110:''' Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. [https://doi.org/10.1056/nejmoa1917346 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32997907/ PubMed] NCT02409342 | ||
##'''Update:''' Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021 Nov;16(11):1872-1882. Epub 2021 Jul 12. [https://doi.org/10.1016/j.jtho.2021.06.019 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34265434/ PubMed] | ##'''Update:''' Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021 Nov;16(11):1872-1882. Epub 2021 Jul 12. [https://doi.org/10.1016/j.jtho.2021.06.019 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34265434/ PubMed] | ||
− | |||
==Carboplatin & Gemcitabine (GCb) {{#subobject:7a8bcz|Regimen=1}}== | ==Carboplatin & Gemcitabine (GCb) {{#subobject:7a8bcz|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, 5/1000 {{#subobject:cxjz01|Variant=1}}=== | ===Regimen variant #1, 5/1000 {{#subobject:cxjz01|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.''<br> | ''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.''<br> | ||
''Note: CrCl in Patil et al. 2019 was calculated using Cockcroft–Gault.'' | ''Note: CrCl in Patil et al. 2019 was calculated using Cockcroft–Gault.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 5.5/1000 {{#subobject:c1ez01|Variant=1}}=== | ===Regimen variant #2, 5.5/1000 {{#subobject:c1ez01|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 198: | Line 194: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 5.5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5.5 IV once on day 1 | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | |||
#'''CALGB 30801:''' Edelman MJ, Wang X, Hodgson L, Cheney RT, Baggstrom MQ, Thomas SP, Gajra A, Bertino E, Reckamp KL, Molina J, Schiller JH, Mitchell-Richards K, Friedman PN, Ritter J, Milne G, Hahn OM, Stinchcombe TE, Vokes EE; Alliance for Clinical Trials in Oncology. Phase III randomized, placebo-controlled, double-blind trial of celecoxib in addition to standard chemotherapy for advanced non-small-cell lung cancer with cyclooxygenase-2 overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 Jul 1;35(19):2184-2192. Epub 2017 May 10. [https://doi.org/10.1200/JCO.2016.71.3743 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5493050/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28489511 PubMed] NCT01041781 | #'''CALGB 30801:''' Edelman MJ, Wang X, Hodgson L, Cheney RT, Baggstrom MQ, Thomas SP, Gajra A, Bertino E, Reckamp KL, Molina J, Schiller JH, Mitchell-Richards K, Friedman PN, Ritter J, Milne G, Hahn OM, Stinchcombe TE, Vokes EE; Alliance for Clinical Trials in Oncology. Phase III randomized, placebo-controlled, double-blind trial of celecoxib in addition to standard chemotherapy for advanced non-small-cell lung cancer with cyclooxygenase-2 overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 Jul 1;35(19):2184-2192. Epub 2017 May 10. [https://doi.org/10.1200/JCO.2016.71.3743 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5493050/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28489511 PubMed] NCT01041781 | ||
#Patil V, Noronha V, Joshi A, Chougule A, Kannan S, Bhattacharjee A, Goud S, More S, Chandrasekharan A, Menon N, Srinivas S, Vallathol DH, Dsouza H, Majumdar S, Das S, Zawar A, Khaddar S, Kumar A, Singh G, Kumar KAP, Ravind R, Trivedi V, Behel V, Mahajan A, Janu A, Purandare N, Prabhash K. Phase III non-inferiority study evaluating efficacy and safety of low dose gemcitabine compared to standard dose gemcitabine with platinum in advanced squamous lung cancer. EClinicalMedicine. 2019 Apr 9;9:19-25. [https://doi.org/10.1016/j.eclinm.2019.03.011 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510888/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31143878 PubMed] CTRI/2013/02/003422 | #Patil V, Noronha V, Joshi A, Chougule A, Kannan S, Bhattacharjee A, Goud S, More S, Chandrasekharan A, Menon N, Srinivas S, Vallathol DH, Dsouza H, Majumdar S, Das S, Zawar A, Khaddar S, Kumar A, Singh G, Kumar KAP, Ravind R, Trivedi V, Behel V, Mahajan A, Janu A, Purandare N, Prabhash K. Phase III non-inferiority study evaluating efficacy and safety of low dose gemcitabine compared to standard dose gemcitabine with platinum in advanced squamous lung cancer. EClinicalMedicine. 2019 Apr 9;9:19-25. [https://doi.org/10.1016/j.eclinm.2019.03.011 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510888/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31143878 PubMed] CTRI/2013/02/003422 | ||
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#'''ORIENT-12:''' Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. [https://doi.org/10.1016/j.jtho.2021.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34048947/ PubMed] NCT03629925 | #'''ORIENT-12:''' Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. [https://doi.org/10.1016/j.jtho.2021.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34048947/ PubMed] NCT03629925 | ||
#'''B-FAST:''' NCT03178552 | #'''B-FAST:''' NCT03178552 | ||
− | |||
==Carboplatin & nab-Paclitaxel {{#subobject:56c054|Regimen=1}}== | ==Carboplatin & nab-Paclitaxel {{#subobject:56c054|Regimen=1}}== | ||
− | |||
CnP: '''<u>C</u>'''arboplatin & '''<u>n</u>'''ab-'''<u>P</u>'''aclitaxel | CnP: '''<u>C</u>'''arboplatin & '''<u>n</u>'''ab-'''<u>P</u>'''aclitaxel | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1, 4 to 6 cycles {{#subobject:0988c0|Variant=1}}=== | ===Regimen variant #1, 4 to 6 cycles {{#subobject:0988c0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 241: | Line 235: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
'''21-day cycle for 4 cycles (KEYNOTE-407) or 4 to 6 cycles (IMpower131)''' | '''21-day cycle for 4 cycles (KEYNOTE-407) or 4 to 6 cycles (IMpower131)''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, indefinite {{#subobject:09hav0|Variant=1}}=== | ===Regimen variant #2, indefinite {{#subobject:09hav0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 264: | Line 258: | ||
|} | |} | ||
''Note: this study included patients that were 70 and older.'' | ''Note: this study included patients that were 70 and older.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 up to 6: AUC 6 IV over 30 minutes once on day 1 | **Cycles 1 up to 6: AUC 6 IV over 30 minutes once on day 1 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15 | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | #'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | ||
##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ||
#'''IMpower131:''' Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. [https://doi.org/10.1016/j.jtho.2020.03.028 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32302702 PubMed] NCT02367794 | #'''IMpower131:''' Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. [https://doi.org/10.1016/j.jtho.2020.03.028 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32302702 PubMed] NCT02367794 | ||
#'''CAPITAL:''' Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. [https://doi.org/10.1016/s2666-7568(21)00255-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/36098037/ PubMed] UMIN000019843 | #'''CAPITAL:''' Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. [https://doi.org/10.1016/s2666-7568(21)00255-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/36098037/ PubMed] UMIN000019843 | ||
− | |||
==Carboplatin, nab-Paclitaxel, Atezolizumab {{#subobject:568ihd|Regimen=1}}== | ==Carboplatin, nab-Paclitaxel, Atezolizumab {{#subobject:568ihd|Regimen=1}}== | ||
− | |||
A+CnP: '''<u>A</u>'''tezolizumab, '''<u>C</u>'''arboplatin, '''<u>n</u>'''ab-'''<u>P</u>'''aclitaxel | A+CnP: '''<u>A</u>'''tezolizumab, '''<u>C</u>'''arboplatin, '''<u>n</u>'''ab-'''<u>P</u>'''aclitaxel | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:0uoja0|Variant=1}}=== | ===Regimen {{#subobject:0uoja0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 300: | Line 291: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 to 4 up to 6: AUC 6 IV once on day 1 | **Cycles 1 to 4 up to 6: AUC 6 IV once on day 1 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | ||
**Cycles 1 to 4 up to 6: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | **Cycles 1 to 4 up to 6: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1 | *[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''IMpower131:''' Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. [https://doi.org/10.1016/j.jtho.2020.03.028 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32302702 PubMed] NCT02367794 | #'''IMpower131:''' Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. [https://doi.org/10.1016/j.jtho.2020.03.028 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32302702 PubMed] NCT02367794 | ||
− | |||
==Carboplatin, nab-Paclitaxel, Pembrolizumab {{#subobject:725667|Regimen=1}}== | ==Carboplatin, nab-Paclitaxel, Pembrolizumab {{#subobject:725667|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:6104db|Variant=1}}=== | ===Regimen {{#subobject:6104db|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 344: | Line 331: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 to 4: AUC 6 IV once on day 1 | **Cycles 1 to 4: AUC 6 IV once on day 1 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | ||
**Cycles 1 to 4: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | **Cycles 1 to 4: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1, '''given first''' | *[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1, '''given first''' | ||
− | |||
'''21-day cycle for up to 35 cycles (2 years)''' | '''21-day cycle for up to 35 cycles (2 years)''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | #'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | ||
##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ||
#'''KEYLYNK-008:''' NCT03976362 | #'''KEYLYNK-008:''' NCT03976362 | ||
#'''KEYVIBE-007:''' NCT05226598 | #'''KEYVIBE-007:''' NCT05226598 | ||
− | |||
==Carboplatin & nab-Paclitaxel (CnP) & Tislelizumab {{#subobject:1dug9b|Regimen=1}}== | ==Carboplatin & nab-Paclitaxel (CnP) & Tislelizumab {{#subobject:1dug9b|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:1cc1f7|Variant=1}}=== | ===Regimen {{#subobject:1cc1f7|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 384: | Line 366: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 to 4 up to 6: AUC 5 IV once on day 1 | **Cycles 1 to 4 up to 6: AUC 5 IV once on day 1 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows: | ||
**Cycles 1 to 4 up to 6: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | **Cycles 1 to 4 up to 6: 100 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Tislelizumab (BGB-A317)]] 200 mg IV once on day 1 | *[[Tislelizumab (BGB-A317)]] 200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
# '''RATIONALE 307:''' Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. [https://doi.org/10.1001/jamaoncol.2021.0366 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8017481/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33792623/ PubMed] NCT03594747 | # '''RATIONALE 307:''' Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. [https://doi.org/10.1001/jamaoncol.2021.0366 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8017481/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33792623/ PubMed] NCT03594747 | ||
− | |||
==Carboplatin & Paclitaxel (CP) {{#subobject:c5fbdf|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) {{#subobject:c5fbdf|Regimen=1}}== | ||
− | |||
TC: '''<u>T</u>'''axol (Paclitaxel) & '''<u>C</u>'''arboplatin | TC: '''<u>T</u>'''axol (Paclitaxel) & '''<u>C</u>'''arboplatin | ||
<br>CP: '''<u>C</u>'''arboplatin & '''<u>P</u>'''aclitaxel | <br>CP: '''<u>C</u>'''arboplatin & '''<u>P</u>'''aclitaxel | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1, 5/175 {{#subobject:5g4ss1|Variant=1}}=== | ===Regimen variant #1, 5/175 {{#subobject:5g4ss1|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 430: | Line 409: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycle for 4 to 6 cycles''' | '''21-day cycle for 4 to 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 5/200 {{#subobject:5g4ff1|Variant=1}}=== | ===Regimen variant #2, 5/200 {{#subobject:5g4ff1|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 452: | Line 431: | ||
|- | |- | ||
|} | |} | ||
− | ''Patients enrolled in this arm of KEYNOTE-042 had squamous histology.'' | + | ''Note: Patients enrolled in this arm of KEYNOTE-042 had squamous histology.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 15 to 60 minutes once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 15 to 60 minutes once on day 1, '''given second''' | ||
*[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | *[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | ||
− | |||
'''21-day cycle for 4 to 6 cycles''' | '''21-day cycle for 4 to 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #3, 6/175 {{#subobject:e3545d|Variant=1}}=== | ===Regimen variant #3, 6/175 {{#subobject:e3545d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 475: | Line 454: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[:Category:Steroids|Corticosteroids]] could be used as premedication for [[Paclitaxel (Taxol)]] infusion. | *[[:Category:Steroids|Corticosteroids]] could be used as premedication for [[Paclitaxel (Taxol)]] infusion. | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #4, 6/200 x 4 {{#subobject:5f5ff1|Variant=1}}=== | ===Regimen variant #4, 6/200 x 4 {{#subobject:5f5ff1|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 507: | Line 484: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 60 minutes once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 60 minutes once on day 1, '''given second''' | ||
*[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | *[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | ||
− | |||
'''21-day cycle for 4 cycles''' | '''21-day cycle for 4 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #5, 6/200 x 6 {{#subobject:5fjxf1|Variant=1}}=== | ===Regimen variant #5, 6/200 x 6 {{#subobject:5fjxf1|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 536: | Line 513: | ||
|} | |} | ||
''<sup>1</sup>The primary endpoint was limited to current smokers, which made up 57% of the cohort.''<br> | ''<sup>1</sup>The primary endpoint was limited to current smokers, which made up 57% of the cohort.''<br> | ||
− | ''Patients enrolled in this arm of KEYNOTE-042 had squamous histology.'' | + | ''Note: Patients enrolled in this arm of KEYNOTE-042 had squamous histology.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 60 minutes once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 60 minutes once on day 1, '''given second''' | ||
*[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | *[[Paclitaxel (Taxol)]] 200 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | #'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | ||
#'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | #'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | ||
Line 558: | Line 533: | ||
# '''GEMSTONE-302:''' Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. [https://doi.org/10.1016/s1470-2045(21)00650-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35038432/ PubMed] NCT03789604 | # '''GEMSTONE-302:''' Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. [https://doi.org/10.1016/s1470-2045(21)00650-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35038432/ PubMed] NCT03789604 | ||
# '''ENREACH-L-01:''' NCT04474119 | # '''ENREACH-L-01:''' NCT04474119 | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Camrelizumab {{#subobject:6hahfd6|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Camrelizumab {{#subobject:6hahfd6|Regimen=1}}== | ||
− | |||
CP & Camrelizumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Camrelizumab | CP & Camrelizumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Camrelizumab | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:3hcb5a|Variant=1}}=== | ===Regimen {{#subobject:3hcb5a|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 577: | Line 551: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
Line 584: | Line 559: | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Camrelizumab (AiRuiKa)]] 200 mg IV once on day 1 | *[[Camrelizumab (AiRuiKa)]] 200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''CameL-Sq:''' Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. Epub 2021 Dec 16. [https://doi.org/10.1016/j.jtho.2021.11.018 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34923163/ PubMed] NCT03668496 | # '''CameL-Sq:''' Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. Epub 2021 Dec 16. [https://doi.org/10.1016/j.jtho.2021.11.018 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34923163/ PubMed] NCT03668496 | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Ipilimumab {{#subobject:e8ba81|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Ipilimumab {{#subobject:e8ba81|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:f70cfc|Variant=1}}=== | ===Regimen {{#subobject:f70cfc|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 608: | Line 581: | ||
|} | |} | ||
''Note: this is the "phased" approach to this regimen.'' | ''Note: this is the "phased" approach to this regimen.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Ipilimumab (Yervoy)]] as follows: | *[[Ipilimumab (Yervoy)]] as follows: | ||
**Cycles 3 to 6: 10 mg/kg IV once on day 1 | **Cycles 3 to 6: 10 mg/kg IV once on day 1 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[:Category:Steroids|Corticosteroids]] could be used as premedication for [[Paclitaxel (Taxol)]] infusion or for toxicity management. | *[[:Category:Steroids|Corticosteroids]] could be used as premedication for [[Paclitaxel (Taxol)]] infusion or for toxicity management. | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*[[#Ipilimumab_monotherapy|Ipilimumab]] maintenance | *[[#Ipilimumab_monotherapy|Ipilimumab]] maintenance | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | #'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Ipilimumab, Nivolumab {{#subobject:23ijqo|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Ipilimumab, Nivolumab {{#subobject:23ijqo|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:18vu81|Variant=1}}=== | ===Regimen {{#subobject:18vu81|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 649: | Line 616: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 & 2: AUC 6 IV once on day 1 | **Cycles 1 & 2: AUC 6 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] as follows: | *[[Paclitaxel (Taxol)]] as follows: | ||
**Cycles 1 & 2: 200 mg/m<sup>2</sup> IV once on day 1 | **Cycles 1 & 2: 200 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Ipilimumab (Yervoy)]] as follows: | *[[Ipilimumab (Yervoy)]] as follows: | ||
**Odd cycles: 1 mg/kg IV once on day 1 | **Odd cycles: 1 mg/kg IV once on day 1 | ||
*[[Nivolumab (Opdivo)]] 360 mg IV once on day 1, '''given first''' | *[[Nivolumab (Opdivo)]] 360 mg IV once on day 1, '''given first''' | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
# '''CheckMate 9LA:''' Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. Epub 2021 Jan 18. [https://doi.org/10.1016/s1470-2045(20)30641-0 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33476593/ PubMed] NCT03215706 | # '''CheckMate 9LA:''' Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. Epub 2021 Jan 18. [https://doi.org/10.1016/s1470-2045(20)30641-0 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33476593/ PubMed] NCT03215706 | ||
## '''Update:''' Reck M, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Reyes F, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, Paz-Ares L, Carbone DP, Memaj A, Marimuthu S, Zhang X, Tran P, John T. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update. ESMO Open. 2021 Oct;6(5):100273. Epub 2021 Oct 1. Erratum in: ESMO Open. 2021 Dec;6(6):100345. [https://doi.org/10.1016/j.esmoop.2021.100273 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8493593/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34607285/ PubMed] | ## '''Update:''' Reck M, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Reyes F, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, Paz-Ares L, Carbone DP, Memaj A, Marimuthu S, Zhang X, Tran P, John T. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update. ESMO Open. 2021 Oct;6(5):100273. Epub 2021 Oct 1. Erratum in: ESMO Open. 2021 Dec;6(6):100345. [https://doi.org/10.1016/j.esmoop.2021.100273 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8493593/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34607285/ PubMed] | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Pembrolizumab {{#subobject:1dc8a3|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Pembrolizumab {{#subobject:1dc8a3|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:46a0f7|Variant=1}}=== | ===Regimen {{#subobject:46a0f7|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 695: | Line 659: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 to 4: AUC 6 IV once on day 1 | **Cycles 1 to 4: AUC 6 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] as follows: | *[[Paclitaxel (Taxol)]] as follows: | ||
**Cycles 1 to 4: 200 mg/m<sup>2</sup> IV once on day 1 | **Cycles 1 to 4: 200 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1, '''given first''' | *[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1, '''given first''' | ||
− | |||
'''21-day cycle for up to 35 cycles (2 years)''' | '''21-day cycle for up to 35 cycles (2 years)''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | |||
#'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | #'''KEYNOTE-407:''' Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. [https://doi.org/10.1056/NEJMoa1810865 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30280635 PubMed] NCT02775435 | ||
##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ##'''Update:''' Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. [https://doi.org/10.1016/j.jtho.2020.06.015 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32599071/ PubMed] | ||
#'''KEYLYNK-008:''' NCT03976362 | #'''KEYLYNK-008:''' NCT03976362 | ||
#'''KEYVIBE-007:''' NCT05226598 | #'''KEYVIBE-007:''' NCT05226598 | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Sugemalimab {{#subobject:1d8ucd|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Sugemalimab {{#subobject:1d8ucd|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:5g4tll|Variant=1}}=== | ===Regimen {{#subobject:5g4tll|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 730: | Line 691: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
Line 738: | Line 700: | ||
*[[Sugemalimab (Cejemly)]] 1200 mg IV once on day 1 | *[[Sugemalimab (Cejemly)]] 1200 mg IV once on day 1 | ||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''GEMSTONE-302:''' Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. [https://doi.org/10.1016/s1470-2045(21)00650-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35038432/ PubMed] NCT03789604 | # '''GEMSTONE-302:''' Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. [https://doi.org/10.1016/s1470-2045(21)00650-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35038432/ PubMed] NCT03789604 | ||
− | |||
==Carboplatin & Paclitaxel (CP) & Tislelizumab {{#subobject:1dc7yb|Regimen=1}}== | ==Carboplatin & Paclitaxel (CP) & Tislelizumab {{#subobject:1dc7yb|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ugj1f7|Variant=1}}=== | ===Regimen {{#subobject:ugj1f7|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 762: | Line 723: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Carboplatin (Paraplatin)]] as follows: | *[[Carboplatin (Paraplatin)]] as follows: | ||
**Cycles 1 to 4 up to 6: AUC 5 IV once on day 1 | **Cycles 1 to 4 up to 6: AUC 5 IV once on day 1 | ||
*[[Paclitaxel (Taxol)]] as follows: | *[[Paclitaxel (Taxol)]] as follows: | ||
**Cycles 1 to 4 up to 6: 175 mg/m<sup>2</sup> IV once on day 1 | **Cycles 1 to 4 up to 6: 175 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Tislelizumab (BGB-A317)]] 200 mg IV once on day 1 | *[[Tislelizumab (BGB-A317)]] 200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
# '''RATIONALE 307:''' Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. [https://doi.org/10.1001/jamaoncol.2021.0366 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8017481/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33792623/ PubMed] NCT03594747 | # '''RATIONALE 307:''' Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. [https://doi.org/10.1001/jamaoncol.2021.0366 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8017481/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33792623/ PubMed] NCT03594747 | ||
− | |||
==Cisplatin & Docetaxel (DC) {{#subobject:58dfce|Regimen=1}}== | ==Cisplatin & Docetaxel (DC) {{#subobject:58dfce|Regimen=1}}== | ||
− | |||
DC: '''<u>D</u>'''ocetaxel & '''<u>C</u>'''isplatin | DC: '''<u>D</u>'''ocetaxel & '''<u>C</u>'''isplatin | ||
<br>CD: '''<u>C</u>'''isplatin & '''<u>D</u>'''ocetaxel | <br>CD: '''<u>C</u>'''isplatin & '''<u>D</u>'''ocetaxel | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1, 75/75 {{#subobject:8aa93b|Variant=1}}=== | ===Regimen variant #1, 75/75 {{#subobject:8aa93b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 796: | Line 754: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycle for 4 cycles''' | '''21-day cycle for 4 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 80/60 {{#subobject:8ddb3b|Variant=1}}=== | ===Regimen variant #2, 80/60 {{#subobject:8ddb3b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 818: | Line 776: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV once on day 1 | *[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycle for 4 to 6 cycles''' | '''21-day cycle for 4 to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''WJOG5208L:''' Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. [https://doi.org/10.1016/S1470-2045(15)00305-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26522337 PubMed] UMIN000002015 | #'''WJOG5208L:''' Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. [https://doi.org/10.1016/S1470-2045(15)00305-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26522337 PubMed] UMIN000002015 | ||
#'''5501068:''' Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. [https://www.jto.org/article/S1556-0864(18)30782-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30017831 PubMed] NCT02088515 | #'''5501068:''' Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. [https://www.jto.org/article/S1556-0864(18)30782-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30017831 PubMed] NCT02088515 | ||
− | |||
==Cisplatin & Gemcitabine (GC) {{#subobject:fb3ee0|Regimen=1}}== | ==Cisplatin & Gemcitabine (GC) {{#subobject:fb3ee0|Regimen=1}}== | ||
− | |||
GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin | ||
<br>GP: '''<u>G</u>'''emcitabine & '''<u>P</u>'''latinol (Cisplatin) | <br>GP: '''<u>G</u>'''emcitabine & '''<u>P</u>'''latinol (Cisplatin) | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:0e126e|Variant=1}}=== | ===Regimen {{#subobject:0e126e|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 856: | Line 811: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.'' | ''<sup>1</sup>Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 30 minutes once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 30 minutes once on day 1 | ||
*[[Gemcitabine (Gemzar)]] 1250 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1250 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 8 | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''SQUIRE:''' Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. [https://doi.org/10.1016/S1470-2045(15)00021-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26045340 PubMed] NCT00981058 | #'''SQUIRE:''' Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. [https://doi.org/10.1016/S1470-2045(15)00021-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26045340 PubMed] NCT00981058 | ||
##'''Dataset:''' [https://www.projectdatasphere.org/projectdatasphere/html/content/272 Project Data Sphere] | ##'''Dataset:''' [https://www.projectdatasphere.org/projectdatasphere/html/content/272 Project Data Sphere] | ||
Line 872: | Line 825: | ||
#'''ORIENT-12:''' Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. [https://doi.org/10.1016/j.jtho.2021.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34048947/ PubMed] NCT03629925 | #'''ORIENT-12:''' Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. [https://doi.org/10.1016/j.jtho.2021.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34048947/ PubMed] NCT03629925 | ||
#'''B-FAST:''' NCT03178552 | #'''B-FAST:''' NCT03178552 | ||
− | |||
==Cisplatin & Gemcitabine (GC) & Necitumumab {{#subobject:PYR3|Regimen=1}}== | ==Cisplatin & Gemcitabine (GC) & Necitumumab {{#subobject:PYR3|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:PYV3|Variant=1}}=== | ===Regimen {{#subobject:PYV3|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 890: | Line 842: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cisplatin (Platinol)]] as follows: | *[[Cisplatin (Platinol)]] as follows: | ||
**Cycles 1 to 6: 75 mg/m<sup>2</sup> IV over 2 hours once on day 1 | **Cycles 1 to 6: 75 mg/m<sup>2</sup> IV over 2 hours once on day 1 | ||
Line 898: | Line 850: | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Necitumumab (Portrazza)]] 800 mg IV over at least 50 minutes once per day on days 1 & 8 | *[[Necitumumab (Portrazza)]] 800 mg IV over at least 50 minutes once per day on days 1 & 8 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*Antiemetic premedications for gemcitabine and cisplatin "according to local practice." | *Antiemetic premedications for gemcitabine and cisplatin "according to local practice." | ||
*"Pre-emptive treatment for skin toxicity was allowed only after the first cycle." | *"Pre-emptive treatment for skin toxicity was allowed only after the first cycle." | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''SQUIRE:''' Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. [https://doi.org/10.1016/S1470-2045(15)00021-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26045340 PubMed] NCT00981058 | #'''SQUIRE:''' Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. [https://doi.org/10.1016/S1470-2045(15)00021-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26045340 PubMed] NCT00981058 | ||
##'''Dataset:''' [https://www.projectdatasphere.org/projectdatasphere/html/content/272 Project Data Sphere] | ##'''Dataset:''' [https://www.projectdatasphere.org/projectdatasphere/html/content/272 Project Data Sphere] | ||
− | |||
==Docetaxel monotherapy {{#subobject:fd1gga|Regimen=1}}== | ==Docetaxel monotherapy {{#subobject:fd1gga|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:13v5b6|Variant=1}}=== | ===Regimen {{#subobject:13v5b6|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 929: | Line 876: | ||
|} | |} | ||
''Note: This trial enrolled patients who were 70 or older.'' | ''Note: This trial enrolled patients who were 70 or older.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | *[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#'''CAPITAL:''' Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. [https://doi.org/10.1016/s2666-7568(21)00255-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/36098037/ PubMed] UMIN000019843 | #'''CAPITAL:''' Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. [https://doi.org/10.1016/s2666-7568(21)00255-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/36098037/ PubMed] UMIN000019843 | ||
− | |||
==Docetaxel & Nedaplatin {{#subobject:57cfce|Regimen=1}}== | ==Docetaxel & Nedaplatin {{#subobject:57cfce|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:8hha3b|Variant=1}}=== | ===Regimen {{#subobject:8hha3b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 954: | Line 900: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV once on day 1 | *[[Docetaxel (Taxotere)]] 60 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Nedaplatin (Aqupla)]] 100 mg/m<sup>2</sup> IV once on day 1 | *[[Nedaplatin (Aqupla)]] 100 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycle for 4 to 6 cycles''' | '''21-day cycle for 4 to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''WJOG5208L:''' Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. [https://doi.org/10.1016/S1470-2045(15)00305-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26522337 PubMed] UMIN000002015 | #'''WJOG5208L:''' Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. [https://doi.org/10.1016/S1470-2045(15)00305-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26522337 PubMed] UMIN000002015 | ||
#'''5501068:''' Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. [https://www.jto.org/article/S1556-0864(18)30782-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30017831 PubMed] NCT02088515 | #'''5501068:''' Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. [https://www.jto.org/article/S1556-0864(18)30782-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30017831 PubMed] NCT02088515 | ||
− | |||
=Maintenance after first-line therapy= | =Maintenance after first-line therapy= | ||
==Ipilimumab monotherapy {{#subobject:b19c3f|Regimen=1}}== | ==Ipilimumab monotherapy {{#subobject:b19c3f|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:b4472a|Variant=1}}=== | ===Regimen {{#subobject:b4472a|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 977: | Line 921: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | |||
*[[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_Ipilimumab|Carboplatin, Paclitaxel, Ipilimumab]] x 6 | *[[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_Ipilimumab|Carboplatin, Paclitaxel, Ipilimumab]] x 6 | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Ipilimumab (Yervoy)]] 10 mg/kg IV once on day 1 | *[[Ipilimumab (Yervoy)]] 10 mg/kg IV once on day 1 | ||
− | |||
'''12-week cycles''' | '''12-week cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | #'''CA184-104:''' Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2016.71.7629 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28854067 PubMed] NCT01285609 | ||
− | |||
==S-1 monotherapy {{#subobject:786af2|Regimen=1}}== | ==S-1 monotherapy {{#subobject:786af2|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:48ibo7|Variant=1}}=== | ===Regimen {{#subobject:48ibo7|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 1,007: | Line 949: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[#Carboplatin_.26_S-1_88|Carboplatin & S-1]] induction | *[[#Carboplatin_.26_S-1_88|Carboplatin & S-1]] induction | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Tegafur, gimeracil, oteracil (S-1)]] 40 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | *[[Tegafur, gimeracil, oteracil (S-1)]] 40 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''WJOG7512L:''' Tanaka K, Morita S, Ando M, Yokoyama T, Nakamura A, Yoshioka H, Ishiguro T, Miura S, Toyozawa R, Oguri T, Daga H, Ko R, Bessho A, Tachihara M, Iwamoto Y, Hirano K, Nakanishi Y, Nakagawa K, Yamamoto N, Okamoto I. A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L). Cancer. 2020 Aug 15;126(16):3648-3656. Epub 2020 Jun 2. [https://doi.org/10.1002/cncr.32987 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32484914 PubMed] UMIN000010396 | #'''WJOG7512L:''' Tanaka K, Morita S, Ando M, Yokoyama T, Nakamura A, Yoshioka H, Ishiguro T, Miura S, Toyozawa R, Oguri T, Daga H, Ko R, Bessho A, Tachihara M, Iwamoto Y, Hirano K, Nakanishi Y, Nakagawa K, Yamamoto N, Okamoto I. A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L). Cancer. 2020 Aug 15;126(16):3648-3656. Epub 2020 Jun 2. [https://doi.org/10.1002/cncr.32987 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32484914 PubMed] UMIN000010396 | ||
− | |||
=Advanced or metastatic disease, second-line= | =Advanced or metastatic disease, second-line= | ||
− | |||
==Afatinib monotherapy {{#subobject:1jg1db|Regimen=1}}== | ==Afatinib monotherapy {{#subobject:1jg1db|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, 30 mg/day {{#subobject:f68gzb|Variant=1}}=== | ===Regimen variant #1, 30 mg/day {{#subobject:f68gzb|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 1,028: | Line 968: | ||
|- | |- | ||
|} | |} | ||
− | ''This is the FDA-recommended dose for patients with "severe renal impairment".'' | + | ''Note: This is the FDA-recommended dose for patients with "severe renal impairment".'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Afatinib (Gilotrif)]] 30 mg PO once per day | *[[Afatinib (Gilotrif)]] 30 mg PO once per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 40 mg/day {{#subobject:130d4a|Variant=1}}=== | ===Regimen variant #2, 40 mg/day {{#subobject:130d4a|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 1,055: | Line 995: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Afatinib (Gilotrif)]] 40 mg PO once per day, given 1 hour before eating food | *[[Afatinib (Gilotrif)]] 40 mg PO once per day, given 1 hour before eating food | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | |||
#'''LUX-Lung 8:''' Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. Epub 2015 Jul 5. [https://doi.org/10.1016/S1470-2045(15)00006-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26156651 PubMed] NCT01523587 | #'''LUX-Lung 8:''' Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. Epub 2015 Jul 5. [https://doi.org/10.1016/S1470-2045(15)00006-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26156651 PubMed] NCT01523587 | ||
##'''Update:''' Goss GD, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Isla D, Morabito A, Min YJ, Ardizzoni A, Bender S, Cseh A, Felip E. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial. EClinicalMedicine. 2021 Jun 18;37:100940. [https://doi.org/10.1016/j.eclinm.2021.100940 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8225678/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34195574/ PubMed] | ##'''Update:''' Goss GD, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Isla D, Morabito A, Min YJ, Ardizzoni A, Bender S, Cseh A, Felip E. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial. EClinicalMedicine. 2021 Jun 18;37:100940. [https://doi.org/10.1016/j.eclinm.2021.100940 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8225678/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34195574/ PubMed] | ||
− | |||
=Advanced or metastatic disease, subsequent lines of therapy= | =Advanced or metastatic disease, subsequent lines of therapy= | ||
''Note: this section includes regimens that were tested in second-line and beyond.'' | ''Note: this section includes regimens that were tested in second-line and beyond.'' | ||
− | |||
==Docetaxel monotherapy {{#subobject:fd1716|Regimen=1}}== | ==Docetaxel monotherapy {{#subobject:fd1716|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:b495b6|Variant=1}}=== | ===Regimen {{#subobject:b495b6|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 1,085: | Line 1,022: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Prior treatment criteria==== | ====Prior treatment criteria==== | ||
*CheckMate 017: One prior [[Regimen_classes#Platinum-based_regimen|platinum-containing regimen]] | *CheckMate 017: One prior [[Regimen_classes#Platinum-based_regimen|platinum-containing regimen]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | *[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#'''CheckMate 017:''' Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. Epub 2015 May 31. [https://doi.org/10.1056/NEJMoa1504627 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4681400/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26028407 PubMed] NCT01642004 | #'''CheckMate 017:''' Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. Epub 2015 May 31. [https://doi.org/10.1056/NEJMoa1504627 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4681400/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26028407 PubMed] NCT01642004 | ||
Line 1,097: | Line 1,036: | ||
##'''HRQoL analysis:''' Reck M, Taylor F, Penrod JR, DeRosa M, Morrissey L, Dastani H, Orsini L, Gralla RJ. Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. J Thorac Oncol. 2018 Feb;13(2):194-204. Epub 2017 Nov 10. [https://www.jto.org/article/S1556-0864(17)32878-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29129758 PubMed] | ##'''HRQoL analysis:''' Reck M, Taylor F, Penrod JR, DeRosa M, Morrissey L, Dastani H, Orsini L, Gralla RJ. Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. J Thorac Oncol. 2018 Feb;13(2):194-204. Epub 2017 Nov 10. [https://www.jto.org/article/S1556-0864(17)32878-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29129758 PubMed] | ||
##'''Pooled update:''' Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. [https://doi.org/10.1200/jco.20.01605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33449799/ PubMed] | ##'''Pooled update:''' Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. [https://doi.org/10.1200/jco.20.01605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33449799/ PubMed] | ||
− | |||
==Nivolumab monotherapy {{#subobject:7e5a40|Regimen=1}}== | ==Nivolumab monotherapy {{#subobject:7e5a40|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:f73cfc|Variant=1}}=== | ===Regimen {{#subobject:f73cfc|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 1,127: | Line 1,065: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Prior treatment criteria==== | ====Prior treatment criteria==== | ||
*CheckMate 017: One prior [[Regimen_classes#Platinum-based_regimen|platinum-containing regimen]] | *CheckMate 017: One prior [[Regimen_classes#Platinum-based_regimen|platinum-containing regimen]] | ||
*Lung-MAP: Previously treated with [[Regimen_classes#Platinum_doublet|platinum-doublet chemotherapy]], no prior immunotherapy | *Lung-MAP: Previously treated with [[Regimen_classes#Platinum_doublet|platinum-doublet chemotherapy]], no prior immunotherapy | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Nivolumab (Opdivo)]] 3 mg/kg IV once on day 1 | *[[Nivolumab (Opdivo)]] 3 mg/kg IV once on day 1 | ||
**Notably, on 9/13/16 the [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm FDA recommended] that dosing for this indication be changed to 240 mg with the same schedule based on updated pharmacokinetic data. | **Notably, on 9/13/16 the [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm FDA recommended] that dosing for this indication be changed to 240 mg with the same schedule based on updated pharmacokinetic data. | ||
− | |||
'''14-day cycles''' | '''14-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''CheckMate 063:''' Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Feb 19. [https://doi.org/10.1016/S1470-2045%2815%2970054-9 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25704439 PubMed] NCT01721759 | #'''CheckMate 063:''' Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Feb 19. [https://doi.org/10.1016/S1470-2045%2815%2970054-9 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25704439 PubMed] NCT01721759 | ||
Line 1,144: | Line 1,083: | ||
##'''Pooled update:''' Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. [https://doi.org/10.1200/jco.20.01605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33449799/ PubMed] | ##'''Pooled update:''' Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. [https://doi.org/10.1200/jco.20.01605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33449799/ PubMed] | ||
#'''Lung-MAP:''' Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer: The Lung-MAP S1400I Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1368-1377. [https://doi.org/10.1001/jamaoncol.2021.2209 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8283667/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34264316/ PubMed] NCT02785952 | #'''Lung-MAP:''' Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer: The Lung-MAP S1400I Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1368-1377. [https://doi.org/10.1001/jamaoncol.2021.2209 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8283667/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34264316/ PubMed] NCT02785952 | ||
− | |||
[[Category:Non-small cell lung cancer regimens]] | [[Category:Non-small cell lung cancer regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Non-small cell lung cancers]] | [[Category:Non-small cell lung cancers]] |
Revision as of 22:58, 9 October 2022
Section editor transclusions Note: these are regimens tested in histology-specific populations, please see the main NSCLC page for other regimens.
40 regimens on this page
57 variants on this page
|
Neoadjuvant therapy
Cisplatin & Gemcitabine (GC)
GC: Gemcitabine & Cisplatin
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Forde et al. 2022 (CheckMate 816) | 2017-2019 | Phase 3 (C) | 1. CP & Nivolumab 2. CVb & Nivolumab 3. DC & Nivolumab 4. GC & Nivolumab |
Inferior EFS |
Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.
Biomarker eligibility criteria
- CheckMate 816: No sensitizing EGFR or ALK mutations
Chemotherapy
- Gemcitabine (Gemzar) 1000 or 1250 mg/m2 IV once per day on days 1 & 8
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
21-day cycle for 3 cycles
Subsequent treatment
References
- CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528
Cisplatin & Gemcitabine (GC) & Nivolumab
GC & Nivolumab: Gemcitabine, Cisplatin, Nivolumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Forde et al. 2022 (CheckMate 816) | 2017-2019 | Phase 3 (E-esc) | 1. CP 2. CVb 3. DC 4. GC |
Superior EFS Median EFS: 31.6 vs 20.8 mo (HR 0.63, 97.38% CI 0.43-0.91) Superior pCR rate 24% vs 2.2% (OR 13.94, 99% CI 3.49-55.75) |
Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.
Biomarker eligibility criteria
- CheckMate 816: No sensitizing EGFR or ALK mutations
Chemotherapy
- Gemcitabine (Gemzar) 1000 or 1250 mg/m2 IV once per day on days 1 & 8
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
Immunotherapy
- Nivolumab (Opdivo) 360 mg IV once on day 1
21-day cycle for 3 cycles
Subsequent treatment
- Complete resection, then adjuvant therapy
References
- CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528
Adjuvant therapy
Cisplatin & Gemcitabine (GC)
GC: Gemcitabine & Cisplatin
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Groen et al. 2019 (NVALT-8) | 2007-2013 | Phase 3 (C) | GC & Nadroparin | Did not meet primary endpoint of RFS |
Preceding treatment
- Complete R0 resection, within 6 weeks
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1250 mg/m2 IV once per day on days 1 & 8
21-day cycle for 4 cycles
References
- NVALT-8: Groen HJM, van der Heijden EHFM, Klinkenberg TJ, Biesma B, Aerts J, Verhagen A, Kloosterziel C, Pieterman R, van den Borne B, Smit HJM, Hoekstra O, Schramel FMNH, van der Noort V, van Tinteren H, Smit EF, Dingemans AC; NVALT Study Group. Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study. Br J Cancer. 2019 Aug;121(5):372-377. Epub 2019 Jul 24. link to original article contains dosing details in manuscript PubMed NTR1250/1217
Advanced or metastatic disease, first-line
Atezolizumab monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Herbst et al. 2020 (IMpower110) | 2015-2018 | Phase 3 (E-RT-switch-ooc) | 1. Carboplatin & Gemcitabine 2. Cisplatin & Gemcitabine |
Superior OS1 (HR 0.59, 95% CI 0.40-0.89) |
1Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.
Biomarker eligibility criteria
- PD-L1 expression on at least 1% of tumor cells or tumor-infiltrating immune cells covering at least 1% of the tumor area as determined by the SP142 assay
References
- IMpower110: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. link to original article contains dosing details in manuscript PubMed NCT02409342
- Update: Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021 Nov;16(11):1872-1882. Epub 2021 Jul 12. link to original article PubMed
Carboplatin & Gemcitabine (GCb)
Regimen variant #1, 5/1000
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Patil et al. 2019 | 2013-2018 | Phase 3 (C) | GCb; low-dose Gemcitabine | Non-inferior OS |
Herbst et al. 2020 (IMpower110) | 2015-2018 | Phase 3 (C) | Atezolizumab | Inferior OS1 |
1Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.
Note: CrCl in Patil et al. 2019 was calculated using Cockcroft–Gault.
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8
21-day cycle for up to 6 cycles
Regimen variant #2, 5.5/1000
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Edelman et al. 2017 (CALGB 30801) | 2010-2013 | Phase 3 (C) | GCb & Celecoxib | Did not meet primary endpoint of PFS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5.5 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8
21-day cycles
References
- CALGB 30801: Edelman MJ, Wang X, Hodgson L, Cheney RT, Baggstrom MQ, Thomas SP, Gajra A, Bertino E, Reckamp KL, Molina J, Schiller JH, Mitchell-Richards K, Friedman PN, Ritter J, Milne G, Hahn OM, Stinchcombe TE, Vokes EE; Alliance for Clinical Trials in Oncology. Phase III randomized, placebo-controlled, double-blind trial of celecoxib in addition to standard chemotherapy for advanced non-small-cell lung cancer with cyclooxygenase-2 overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 Jul 1;35(19):2184-2192. Epub 2017 May 10. link to original article link to PMC article contains dosing details in manuscript PubMed NCT01041781
- Patil V, Noronha V, Joshi A, Chougule A, Kannan S, Bhattacharjee A, Goud S, More S, Chandrasekharan A, Menon N, Srinivas S, Vallathol DH, Dsouza H, Majumdar S, Das S, Zawar A, Khaddar S, Kumar A, Singh G, Kumar KAP, Ravind R, Trivedi V, Behel V, Mahajan A, Janu A, Purandare N, Prabhash K. Phase III non-inferiority study evaluating efficacy and safety of low dose gemcitabine compared to standard dose gemcitabine with platinum in advanced squamous lung cancer. EClinicalMedicine. 2019 Apr 9;9:19-25. link to original article link to PMC article contains dosing details in manuscript PubMed CTRI/2013/02/003422
- MYSTIC: Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. link to original article link to PMC article PubMed NCT02453282
- IMpower110: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. link to original article contains dosing details in manuscript PubMed NCT02409342
- Update: Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021 Nov;16(11):1872-1882. Epub 2021 Jul 12. link to original article PubMed
- ORIENT-12: Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. link to original article PubMed NCT03629925
- B-FAST: NCT03178552
Carboplatin & nab-Paclitaxel
CnP: Carboplatin & nab-Paclitaxel
Regimen variant #1, 4 to 6 cycles
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Jotte et al. 2020 (IMpower131) | 2015-2017 | Phase 3 (C) | 1. A+CnP | Inferior PFS |
2. A+CP | Not reported | |||
Paz-Ares et al. 2018 (KEYNOTE-407) | 2016-2017 | Phase 3 (C) | 1. CP & Pembrolizumab 2. Carboplatin, nab-Paclitaxel, Pembrolizumab |
Inferior OS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 mg/m2 IV once per day on days 1, 8, 15
21-day cycle for 4 cycles (KEYNOTE-407) or 4 to 6 cycles (IMpower131)
Regimen variant #2, indefinite
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kogure et al. 2022 (CAPITAL) | 2016-2020 | Phase 3 (E-esc) | Docetaxel | Superior OS Median OS: 16.9 vs 10.9 mo (HR 0.52, 90% CI 0.38-0.70) |
Note: this study included patients that were 70 and older.
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 up to 6: AUC 6 IV over 30 minutes once on day 1
- Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 mg/m2 IV over 60 minutes once per day on days 1, 8, 15
21-day cycles
References
- KEYNOTE-407: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. link to original article contains dosing details in manuscript PubMed NCT02775435
- Update: Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. link to original article PubMed
- IMpower131: Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. link to original article contains dosing details in manuscript PubMed NCT02367794
- CAPITAL: Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. link to original article contains dosing details in manuscript PubMed UMIN000019843
Carboplatin, nab-Paclitaxel, Atezolizumab
A+CnP: Atezolizumab, Carboplatin, nab-Paclitaxel
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Jotte et al. 2020 (IMpower131) | 2015-2017 | Phase 3 (E-esc) | 1. CnP | Superior PFS Median PFS: 6.3 vs 5.6 mo (HR 0.71, 95% CI 0.60-0.85) |
2. A+CP | Not reported |
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4 up to 6: AUC 6 IV once on day 1
- Paclitaxel, nanoparticle albumin-bound (Abraxane) as follows:
- Cycles 1 to 4 up to 6: 100 mg/m2 IV once per day on days 1, 8, 15
Immunotherapy
- Atezolizumab (Tecentriq) 1200 mg IV once on day 1
21-day cycles
References
- IMpower131: Jotte R, Cappuzzo F, Vynnychenko I, Stroyakovskiy D, Rodríguez-Abreu D, Hussein M, Soo R, Conter HJ, Kozuki T, Huang KC, Graupner V, Sun SW, Hoang T, Jessop H, McCleland M, Ballinger M, Sandler A, Socinski MA. Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug;15(8):1351-1360. Epub 2020 Apr 14. link to original article contains dosing details in manuscript PubMed NCT02367794
Carboplatin, nab-Paclitaxel, Pembrolizumab
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Paz-Ares et al. 2018 (KEYNOTE-407) | 2016-2017 | Phase 3 (E-RT-esc) | 1. CP 2. Carboplatin & nab-Paclitaxel |
Superior OS1 Median OS: 17.1 mo vs 11.6 mo (HR 0.71, 95% CI 0.58-0.88) |
Awaiting publication (KEYVIBE-007) | 2022-2025 | Phase 3 (C) | 1. CP, Pembrolizumab, Vibostolimab 2. Carboplatin, nab-Paclitaxel, Pembrolizumab, Vibostolimab |
TBD |
1Reported efficacy is based on the 2021 update.
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4: AUC 6 IV once on day 1
- Paclitaxel, nanoparticle albumin-bound (Abraxane) as follows:
- Cycles 1 to 4: 100 mg/m2 IV once per day on days 1, 8, 15
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once on day 1, given first
21-day cycle for up to 35 cycles (2 years)
References
- KEYNOTE-407: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. link to original article contains dosing details in manuscript PubMed NCT02775435
- Update: Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. link to original article PubMed
- KEYLYNK-008: NCT03976362
- KEYVIBE-007: NCT05226598
Carboplatin & nab-Paclitaxel (CnP) & Tislelizumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wang et al. 2021 (RATIONALE 307) | rowspan=2 2018-2019 | Phase 3 (E-esc) | 1. CP | Superior PFS Median PFS: 7.6 vs 5.5 mo (HR 0.48, 95% CI 0.34-0.68) |
2. CP & Tislelizumab | Not reported |
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4 up to 6: AUC 5 IV once on day 1
- Paclitaxel, nanoparticle albumin-bound (Abraxane) as follows:
- Cycles 1 to 4 up to 6: 100 mg/m2 IV once per day on days 1, 8, 15
Immunotherapy
- Tislelizumab (BGB-A317) 200 mg IV once on day 1
21-day cycles
References
- RATIONALE 307: Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. link to original article link to PMC article contains dosing details in manuscript PubMed NCT03594747
Carboplatin & Paclitaxel (CP)
TC: Taxol (Paclitaxel) & Carboplatin
CP: Carboplatin & Paclitaxel
Regimen variant #1, 5/175
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wang et al. 2021 (RATIONALE 307) | 2018-2019 | Phase 3 (C) | 1. CP & Tislelizumab 2. CnP & Tislelizumab |
Inferior PFS |
Ren et al. 2021 (CameL-Sq) | 2018-2019 | Phase 3 (C) | CP & Camrelizumab | Inferior OS |
Zhou et al. 2022 (GEMSTONE-302) | 2018-2020 | Phase 3 (C) | CP & Sugemalimab | Inferior PFS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
21-day cycle for 4 to 6 cycles
Regimen variant #2, 5/200
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mok et al. 2019 (KEYNOTE-042) | 2014-2017 | Phase 3 (C) | Pembrolizumab | Inferior OS |
Note: Patients enrolled in this arm of KEYNOTE-042 had squamous histology.
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 15 to 60 minutes once on day 1, given second
- Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours once on day 1, given first
21-day cycle for 4 to 6 cycles
Regimen variant #3, 6/175
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Govindan et al. 2017 (CA184-104) | 2011-2015 | Phase 3 (C) | TC & Ipilimumab | Did not meet primary endpoint of OS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
Supportive therapy
- Corticosteroids could be used as premedication for Paclitaxel (Taxol) infusion.
21-day cycle for up to 6 cycles
Regimen variant #4, 6/200 x 4
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Paz-Ares et al. 2018 (KEYNOTE-407) | 2016-2017 | Phase 3 (C) | 1. CP & Pembrolizumab 2. Carboplatin, nab-Paclitaxel, Pembrolizumab |
Inferior OS |
Paz-Ares et al. 2021 (CheckMate 9LA) | 2017-2019 | Phase 3 (C) | Carboplatin, Paclitaxel, Ipilimumab, Nivolumab | Inferior OS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 15 to 60 minutes once on day 1, given second
- Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours once on day 1, given first
21-day cycle for 4 cycles
Regimen variant #5, 6/200 x 6
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mok et al. 2019 (KEYNOTE-042) | 2014-2017 | Phase 3 (C) | Pembrolizumab | Inferior OS |
Ramalingam et al. 2021 (M11-089) | 2014-2019 | Phase 3 (C) | CP & Veliparib | Did not meet primary endpoint of OS1 Median OS: 11.1 vs 11.9 mo (HR 1.10, 95% CI 0.91-1.34) |
1The primary endpoint was limited to current smokers, which made up 57% of the cohort.
Note: Patients enrolled in this arm of KEYNOTE-042 had squamous histology.
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 15 to 60 minutes once on day 1, given second
- Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours once on day 1, given first
21-day cycle for up to 6 cycles
References
- CA184-104: Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. link to original article contains dosing details in manuscript PubMed NCT01285609
- KEYNOTE-407: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. link to original article contains dosing details in manuscript PubMed NCT02775435
- Update: Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. link to original article PubMed
- KEYNOTE-042: Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. Epub 2019 Apr 4. link to original article PubMed NCT02220894
- CheckMate 9LA: Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. Epub 2021 Jan 18. link to original article contains dosing details in manuscript PubMed NCT03215706
- Update: Reck M, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Reyes F, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, Paz-Ares L, Carbone DP, Memaj A, Marimuthu S, Zhang X, Tran P, John T. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update. ESMO Open. 2021 Oct;6(5):100273. Epub 2021 Oct 1. Erratum in: ESMO Open. 2021 Dec;6(6):100345. link to original article link to PMC article PubMed
- RATIONALE 307: Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. link to original article link to PMC article contains dosing details in manuscript PubMed NCT03594747
- M11-089: Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. Epub 2021 Aug 26. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02106546
- CameL-Sq: Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. Epub 2021 Dec 16. link to original article contains dosing details in manuscript PubMed NCT03668496
- GEMSTONE-302: Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. link to original article contains dosing details in abstract PubMed NCT03789604
- ENREACH-L-01: NCT04474119
Carboplatin & Paclitaxel (CP) & Camrelizumab
CP & Camrelizumab: Carboplatin, Paclitaxel, Camrelizumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Ren et al. 2021 (CameL-Sq) | 2018-2019 | Phase 3 (E-esc) | CP | Superior OS Median OS: NYR vs 14.5 mo (HR 0.55, 95% CI 0.40-0.75) |
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4 up to 6: AUC 5 IV once on day 1
- Paclitaxel (Taxol) as follows:
- Cycles 1 to 4 up to 6: 175 mg/m2 IV once on day 1
Immunotherapy
- Camrelizumab (AiRuiKa) 200 mg IV once on day 1
21-day cycles
References
- CameL-Sq: Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. Epub 2021 Dec 16. link to original article contains dosing details in manuscript PubMed NCT03668496
Carboplatin & Paclitaxel (CP) & Ipilimumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Govindan et al. 2017 (CA184-104) | 2011-2015 | Phase 3 (E-esc) | Carboplatin & Paclitaxel | Did not meet primary endpoint of OS |
Note: this is the "phased" approach to this regimen.
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
Immunotherapy
- Ipilimumab (Yervoy) as follows:
- Cycles 3 to 6: 10 mg/kg IV once on day 1
Supportive therapy
- Corticosteroids could be used as premedication for Paclitaxel (Taxol) infusion or for toxicity management.
21-day cycle for up to 6 cycles
Subsequent treatment
- Ipilimumab maintenance
References
- CA184-104: Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. link to original article contains dosing details in manuscript PubMed NCT01285609
Carboplatin & Paclitaxel (CP) & Ipilimumab, Nivolumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Paz-Ares et al. 2021 (CheckMate 9LA) | 2017-2019 | Phase 3 (E-RT-switch-ooc) | 1. Carboplatin & Pemetrexed 2. Cisplatin & Pemetrexed |
Superior OS1 Median OS: 15.8 vs 11 mo (HR 0.72, 95% CI 0.61-0.86) |
1Reported efficacy is based on the 2021 update.
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 & 2: AUC 6 IV once on day 1
- Paclitaxel (Taxol) as follows:
- Cycles 1 & 2: 200 mg/m2 IV once on day 1
Immunotherapy
- Ipilimumab (Yervoy) as follows:
- Odd cycles: 1 mg/kg IV once on day 1
- Nivolumab (Opdivo) 360 mg IV once on day 1, given first
21-day cycles
References
- CheckMate 9LA: Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. Epub 2021 Jan 18. link to original article contains dosing details in manuscript PubMed NCT03215706
- Update: Reck M, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Reyes F, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, Paz-Ares L, Carbone DP, Memaj A, Marimuthu S, Zhang X, Tran P, John T. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update. ESMO Open. 2021 Oct;6(5):100273. Epub 2021 Oct 1. Erratum in: ESMO Open. 2021 Dec;6(6):100345. link to original article link to PMC article PubMed
Carboplatin & Paclitaxel (CP) & Pembrolizumab
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Paz-Ares et al. 2018 (KEYNOTE-407) | 2016-2017 | Phase 3 (E-RT-esc) | 1. CP 2. Carboplatin & nab-Paclitaxel |
Superior OS1 Median OS: 17.1 mo vs 11.6 mo (HR 0.71, 95% CI 0.58-0.88) |
Awaiting publication (KEYVIBE-007) | 2022-2025 | Phase 3 (C) | 1. CP, Pembrolizumab, Vibostolimab 2. Carboplatin, nab-Paclitaxel, Pembrolizumab, Vibostolimab |
TBD |
1Reported efficacy is based on the 2021 update.
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4: AUC 6 IV once on day 1
- Paclitaxel (Taxol) as follows:
- Cycles 1 to 4: 200 mg/m2 IV once on day 1
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once on day 1, given first
21-day cycle for up to 35 cycles (2 years)
References
- KEYNOTE-407: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. Epub 2018 Sep 25. link to original article contains dosing details in manuscript PubMed NCT02775435
- Update: Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazières J, Hermes B, Cicin I, Medgyasszay B, Rodríguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. Epub 2020 Jun 26. link to original article PubMed
- KEYLYNK-008: NCT03976362
- KEYVIBE-007: NCT05226598
Carboplatin & Paclitaxel (CP) & Sugemalimab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Zhou et al. 2022 (GEMSTONE-302) | 2018-2020 | Phase 3 (E-esc) | CP | Superior PFS Median PFS: 9 vs 4.9 mo (HR 0.48, 95% CI 0.39-0.60) |
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4: AUC 5 IV once on day 1
- Paclitaxel (Taxol) as follows:
- Cycles 1 to 4: 175 mg/m2 IV once on day 1
Immunotherapy
- Sugemalimab (Cejemly) 1200 mg IV once on day 1
21-day cycles
References
- GEMSTONE-302: Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. Epub 2022 Jan 14. link to original article contains dosing details in abstract PubMed NCT03789604
Carboplatin & Paclitaxel (CP) & Tislelizumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wang et al. 2021 (RATIONALE 307) | rowspan=2 2018-2019 | Phase 3 (E-esc) | 1. CP | Superior PFS Median PFS: 7.6 vs 5.5 mo (HR 0.52, 95% CI 0.37-0.74) |
2. CnP & Tislelizumab | Not reported |
Chemotherapy
- Carboplatin (Paraplatin) as follows:
- Cycles 1 to 4 up to 6: AUC 5 IV once on day 1
- Paclitaxel (Taxol) as follows:
- Cycles 1 to 4 up to 6: 175 mg/m2 IV once on day 1
Immunotherapy
- Tislelizumab (BGB-A317) 200 mg IV once on day 1
21-day cycles
References
- RATIONALE 307: Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Epub 2021 Apr 1. link to original article link to PMC article contains dosing details in manuscript PubMed NCT03594747
Cisplatin & Docetaxel (DC)
DC: Docetaxel & Cisplatin
CD: Cisplatin & Docetaxel
Regimen variant #1, 75/75
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lu et al. 2018 (5501068) | 2013-2015 | Phase 3 (C) | Docetaxel & Nedaplatin | Might have inferior PFS |
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
- Docetaxel (Taxotere) 75 mg/m2 IV once on day 1
21-day cycle for 4 cycles
Regimen variant #2, 80/60
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Shukuya et al. 2015 (WJOG5208L) | 2009-2012 | Phase 3 (C) | Docetaxel & Nedaplatin | Might have inferior OS |
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
- Docetaxel (Taxotere) 60 mg/m2 IV once on day 1
21-day cycle for 4 to 6 cycles
References
- WJOG5208L: Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. link to original article contains dosing details in abstract PubMed UMIN000002015
- 5501068: Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. link to original article contains dosing details in manuscript PubMed NCT02088515
Cisplatin & Gemcitabine (GC)
GC: Gemcitabine & Cisplatin
GP: Gemcitabine & Platinol (Cisplatin)
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Thatcher et al. 2015 (SQUIRE) | 2010-2012 | Phase 3 (C) | Cisplatin, Gemcitabine, Necitumumab | Seems to have inferior OS |
Herbst et al. 2020 (IMpower110) | 2015-2018 | Phase 3 (C) | Atezolizumab | Inferior OS1 |
1Reported efficacy for IMpower110 is for TC3/IC3 only i.e., PD-L1 TC>50%.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV over 30 minutes once on day 1
- Gemcitabine (Gemzar) 1250 mg/m2 IV over 2 hours once per day on days 1 & 8
21-day cycle for up to 6 cycles
References
- SQUIRE: Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. link to original article contains dosing details in abstract PubMed NCT00981058
- Dataset: Project Data Sphere
- MYSTIC: Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. link to original article link to PMC article PubMed NCT02453282
- IMpower110: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. link to original article contains dosing details in manuscript PubMed NCT02409342
- Update: Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1-Selected NSCLC. J Thorac Oncol. 2021 Nov;16(11):1872-1882. Epub 2021 Jul 12. link to original article PubMed
- ORIENT-12: Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. Epub 2021 May 25. link to original article PubMed NCT03629925
- B-FAST: NCT03178552
Cisplatin & Gemcitabine (GC) & Necitumumab
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Thatcher et al. 2015 (SQUIRE) | 2010-2012 | Phase 3 (E-RT-esc) | Cisplatin & Gemcitabine | Seems to have superior OS Median OS: 11.5 vs 9.9 mo (HR 0.84, 95% CI 0.74-0.96) |
Chemotherapy
- Cisplatin (Platinol) as follows:
- Cycles 1 to 6: 75 mg/m2 IV over 2 hours once on day 1
- Gemcitabine (Gemzar) as follows:
- Cycles 1 to 6: 1250 mg/m2 IV over 30 minutes once per day on days 1 & 8
Targeted therapy
- Necitumumab (Portrazza) 800 mg IV over at least 50 minutes once per day on days 1 & 8
Supportive therapy
- Antiemetic premedications for gemcitabine and cisplatin "according to local practice."
- "Pre-emptive treatment for skin toxicity was allowed only after the first cycle."
21-day cycles
References
- SQUIRE: Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. Epub 2015 Jun 1. link to original article contains dosing details in manuscript PubMed NCT00981058
- Dataset: Project Data Sphere
Docetaxel monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kogure et al. 2022 (CAPITAL) | 2016-2020 | Phase 3 (C) | CnP | Inferior OS |
Note: This trial enrolled patients who were 70 or older.
References
- CAPITAL: Kogure Y, Iwasawa S, Saka H, Hamamoto Y, Kada A, Hashimoto H, Atagi S, Takiguchi Y, Ebi N, Inoue A, Kurata T, Okamoto I, Yamaguchi M, Harada T, Seike M, Ando M, Saito AM, Kubota K, Takenoyama M, Seto T, Yamamoto N, Gemma A. Efficacy and safety of carboplatin with nab-paclitaxel versus docetaxel in older patients with squamous non-small-cell lung cancer (CAPITAL): a randomised, multicentre, open-label, phase 3 trial. Lancet Healthy Longev. 2021 Dec;2(12):e791-e800. link to original article contains dosing details in manuscript PubMed UMIN000019843
Docetaxel & Nedaplatin
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Shukuya et al. 2015 (WJOG5208L) | 2009-2012 | Phase 3 (E-switch-ic) | Cisplatin & Docetaxel | Might have superior OS Median OS: 13.6 vs 11.4 mo (HR 0.81, 95% CI 0.65-1.02) |
Chemotherapy
- Docetaxel (Taxotere) 60 mg/m2 IV once on day 1
- Nedaplatin (Aqupla) 100 mg/m2 IV once on day 1
21-day cycle for 4 to 6 cycles
References
- WJOG5208L: Shukuya T, Yamanaka T, Seto T, Daga H, Goto K, Saka H, Sugawara S, Takahashi T, Yokota S, Kaneda H, Kawaguchi T, Nagase S, Oguri T, Iwamoto Y, Nishimura T, Hattori Y, Nakagawa K, Nakanishi Y, Yamamoto N; West Japan Oncology Group. Nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung (WJOG5208L): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Dec;16(16):1630-8. Epub 2015 Oct 28. link to original article contains dosing details in abstract PubMed UMIN000002015
- 5501068: Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung - a multicenter, open-label, randomized, phase III trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. Epub 2018 Jul 11. link to original article contains dosing details in manuscript PubMed NCT02088515
Maintenance after first-line therapy
Ipilimumab monotherapy
Regimen
Study | Evidence |
---|---|
Govindan et al. 2017 (CA184-104) | Non-randomized portion of RCT |
Preceding treatment
References
- CA184-104: Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M. Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol. 2017 Oct 20;35(30):3449-3457. Epub 2017 Aug 30. link to original article contains dosing details in manuscript PubMed NCT01285609
S-1 monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tanaka et al. 2020 (WJOG7512L) | 2013-2017 | Phase 3 (E-esc) | Observation | Superior PFS |
Preceding treatment
- Carboplatin & S-1 induction
Chemotherapy
- Tegafur, gimeracil, oteracil (S-1) 40 mg/m2 PO twice per day on days 1 to 14
21-day cycles
References
- WJOG7512L: Tanaka K, Morita S, Ando M, Yokoyama T, Nakamura A, Yoshioka H, Ishiguro T, Miura S, Toyozawa R, Oguri T, Daga H, Ko R, Bessho A, Tachihara M, Iwamoto Y, Hirano K, Nakanishi Y, Nakagawa K, Yamamoto N, Okamoto I. A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L). Cancer. 2020 Aug 15;126(16):3648-3656. Epub 2020 Jun 2. link to original article contains dosing details in manuscript PubMed UMIN000010396
Advanced or metastatic disease, second-line
Afatinib monotherapy
Regimen variant #1, 30 mg/day
FDA-recommended dose |
Note: This is the FDA-recommended dose for patients with "severe renal impairment".
Regimen variant #2, 40 mg/day
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Soria et al. 2015 (LUX-Lung 8) | 2012-2014 | Phase 3 (E-RT-switch-ic) | Erlotinib | Seems to have superior OS1 Median OS: 7.8 vs 6.8 mo (HR 0.84, 95% CI 0.73-0.97) |
1Reported efficacy is based on the 2021 update.
Targeted therapy
- Afatinib (Gilotrif) 40 mg PO once per day, given 1 hour before eating food
Continued indefinitely
References
- LUX-Lung 8: Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. Epub 2015 Jul 5. link to original article contains dosing details in abstract PubMed NCT01523587
- Update: Goss GD, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Isla D, Morabito A, Min YJ, Ardizzoni A, Bender S, Cseh A, Felip E. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial. EClinicalMedicine. 2021 Jun 18;37:100940. link to original article link to PMC article PubMed
Advanced or metastatic disease, subsequent lines of therapy
Note: this section includes regimens that were tested in second-line and beyond.
Docetaxel monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Brahmer et al. 2015 (CheckMate 017) | 2012-2013 | Phase 3 (C) | Nivolumab | Inferior OS |
Prior treatment criteria
- CheckMate 017: One prior platinum-containing regimen
References
- CheckMate 017: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. Epub 2015 May 31. link to original article link to PMC article PubMed NCT01642004
- Pooled update: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. Epub 2017 Oct 12. link to original article PubMed
- HRQoL analysis: Reck M, Taylor F, Penrod JR, DeRosa M, Morrissey L, Dastani H, Orsini L, Gralla RJ. Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. J Thorac Oncol. 2018 Feb;13(2):194-204. Epub 2017 Nov 10. link to original article PubMed
- Pooled update: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. link to original article PubMed
Nivolumab monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Rizvi et al. 2015 (CheckMate 063) | 2012-2013 | Phase 2 | ||
Brahmer et al. 2015 (CheckMate 017) | 2012-2013 | Phase 3 (E-RT-switch-ooc) | Docetaxel | Superior OS Median OS: 9 vs 6 mo (HR 0.59, 95% CI 0.44-0.79) |
Gettinger et al. 2021 (Lung-MAP) | 2015-2018 | Phase 3 (C) | Ipilimumab & Nivolumab | Did not meet primary endpoint of OS |
Prior treatment criteria
- CheckMate 017: One prior platinum-containing regimen
- Lung-MAP: Previously treated with platinum-doublet chemotherapy, no prior immunotherapy
Immunotherapy
- Nivolumab (Opdivo) 3 mg/kg IV once on day 1
- Notably, on 9/13/16 the FDA recommended that dosing for this indication be changed to 240 mg with the same schedule based on updated pharmacokinetic data.
14-day cycles
References
- CheckMate 063: Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Feb 19. link to original article contains dosing details in manuscript PubMed NCT01721759
- CheckMate 017: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. Epub 2015 May 31. link to original article link to PMC article PubMed NCT01642004
- Pooled update: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. Epub 2017 Oct 12. link to original article PubMed
- HRQoL analysis: Reck M, Taylor F, Penrod JR, DeRosa M, Morrissey L, Dastani H, Orsini L, Gralla RJ. Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. J Thorac Oncol. 2018 Feb;13(2):194-204. Epub 2017 Nov 10. link to original article PubMed
- Pooled update: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. Epub 2021 Jan 15. link to original article PubMed
- Lung-MAP: Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer: The Lung-MAP S1400I Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1368-1377. link to original article link to PMC article contains dosing details in abstract PubMed NCT02785952