Difference between revisions of "Non-small cell lung cancer, HER2-mutated"
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− | {{#lst: | + | <span id="BackToTop"></span> |
+ | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | ||
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | {{#lst:Editorial board transclusions|nsclc}} | ||
Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens. | Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens. | ||
+ | <br>There are several related dedicated pages: | ||
+ | *'''Histology-specific:''' | ||
+ | **'''[[Non-small_cell_lung_cancer,_nonsquamous|NSCLC, Nonsquamous]]''' | ||
+ | **'''[[Non-small_cell_lung_cancer,_squamous|NSCLC, Squamous]]''' | ||
+ | *'''Site-specific:''' | ||
+ | **'''[[Non-small cell lung cancer, CNS metastases|NSCLC, CNS metastases]]''' | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
+ | ==[https://www.asco.org/ ASCO]== | ||
+ | *'''2022:''' Singh et al. [https://doi.org/10.1200/jco.22.00824 Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline] [https://pubmed.ncbi.nlm.nih.gov/35816666 PubMed] | ||
+ | |||
+ | ==[https://www.esmo.org/ ESMO]== | ||
+ | *'''2023:''' Hendriks et al. [https://doi.org/10.1016/j.annonc.2022.12.009 Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/36872130 PubMed] | ||
+ | |||
+ | ==NCCN== | ||
+ | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450 NCCN Guidelines - Non-Small Cell Lung Cancer].'' | ||
+ | |||
=Metastatic disease, all lines of therapy= | =Metastatic disease, all lines of therapy= | ||
+ | ==Carboplatin, Pemetrexed, Pembrolizumab {{#subobject:a3c8c5|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:04328c|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://www.clinicaltrials.gov/study/NCT05048797 Awaiting publication (DESTINY-Lung04)] | ||
+ | |2021-ongoing | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[#Trastuzumab_deruxtecan_monotherapy|T-DXd]] | ||
+ | |style="background-color:#d3d3d3"|TBD if different primary endpoint of PFS | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Carboplatin (Paraplatin)]] | ||
+ | *[[Pemetrexed (Alimta)]] | ||
+ | ====Immunotherapy==== | ||
+ | *[[Pembrolizumab (Keytruda)]] | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''DESTINY-Lung04:''' [https://clinicaltrials.gov/study/NCT05048797 NCT05048797] | ||
+ | ==Cisplatin, Pemetrexed, Pembrolizumab {{#subobject:a3csc5|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:04sp8c|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://www.clinicaltrials.gov/study/NCT05048797 Awaiting publication (DESTINY-Lung04)] | ||
+ | |2021-ongoing | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[#Trastuzumab_deruxtecan_monotherapy|T-DXd]] | ||
+ | |style="background-color:#d3d3d3"|TBD if different primary endpoint of PFS | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] | ||
+ | *[[Pemetrexed (Alimta)]] | ||
+ | ====Immunotherapy==== | ||
+ | *[[Pembrolizumab (Keytruda)]] | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''DESTINY-Lung04:''' [https://clinicaltrials.gov/study/NCT05048797 NCT05048797] | ||
==Trastuzumab deruxtecan monotherapy {{#subobject:7hg71v|Regimen=1}}== | ==Trastuzumab deruxtecan monotherapy {{#subobject:7hg71v|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen variant #1, 5.4 mg/kg {{#subobject:f3hug9|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="color:white; background-color:#404040" | ||
+ | |<small>'''FDA-recommended dose'''</small> | ||
|- | |- | ||
− | |||
|} | |} | ||
− | |||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ Goto et al. 2023 (DESTINY-Lung02)] |
+ | |2021-03 to 2022-03 | ||
+ | |style="background-color:#91cf61"|Phase 2 (RT) | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
+ | ====Biomarker eligibility criteria==== | ||
+ | *HER2 mutations | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Antibody-drug conjugate therapy==== | ||
+ | *[[Trastuzumab deruxtecan (Enhertu)]] 5.4 mg/kg IV once on day 1 | ||
+ | '''21-day cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2, 6.4 mg/kg {{#subobject:f3eig9|Variant=1}}=== | ||
+ | {| class="wikitable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9066448/ Li et al. 2021 (DESTINY-Lung01)] | ||
|2018-2020 | |2018-2020 | ||
+ | |style="background-color:#91cf61"|Phase 2 | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ Goto et al. 2023 (DESTINY-Lung02)] | ||
+ | |2021-03 to 2022-03 | ||
|style="background-color:#91cf61"|Phase 2 | |style="background-color:#91cf61"|Phase 2 | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*HER2 mutations | *HER2 mutations | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Antibody-drug conjugate therapy==== | ====Antibody-drug conjugate therapy==== | ||
− | |||
*[[Trastuzumab deruxtecan (Enhertu)]] 6.4 mg/kg IV once on day 1 | *[[Trastuzumab deruxtecan (Enhertu)]] 6.4 mg/kg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | #'''DESTINY-Lung01:''' Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2021 Sep 18 | + | #'''DESTINY-Lung01:''' Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. [https://doi.org/10.1056/nejmoa2112431 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9066448/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34534430/ PubMed] [https://clinicaltrials.gov/study/NCT03505710 NCT03505710] |
− | + | #'''DESTINY-Lung02:''' Goto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, Ahn MJ, Smit EF, de Langen AJ, Pérol M, Pons-Tostivint E, Novello S, Hayashi H, Shimizu J, Kim DW, Kuo CH, Yang JC, Pereira K, Cheng FC, Taguchi A, Cheng Y, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. J Clin Oncol. 2023 Nov 1;41(31):4852-4863. Epub 2023 Sep 11. Erratum in: J Clin Oncol. 2023 Dec 19;:JCO2302574. [https://doi.org/10.1200/jco.23.01361 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/37694347/ PubMed] [https://clinicaltrials.gov/study/NCT04644237 NCT04644237] | |
[[Category:Non-small cell lung cancer regimens]] | [[Category:Non-small cell lung cancer regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Non-small cell lung cancers]] | [[Category:Non-small cell lung cancers]] |
Latest revision as of 12:26, 18 July 2024
Page editor | Section editor | ||
---|---|---|---|
Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX, USA |
Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN, USA |
Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
There are several related dedicated pages:
- Histology-specific:
- Site-specific:
3 regimens on this page
4 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ASCO
- 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline PubMed
ESMO
- 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Non-Small Cell Lung Cancer.
Metastatic disease, all lines of therapy
Carboplatin, Pemetrexed, Pembrolizumab
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (DESTINY-Lung04) | 2021-ongoing | Phase 3 (C) | T-DXd | TBD if different primary endpoint of PFS |
References
- DESTINY-Lung04: NCT05048797
Cisplatin, Pemetrexed, Pembrolizumab
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (DESTINY-Lung04) | 2021-ongoing | Phase 3 (C) | T-DXd | TBD if different primary endpoint of PFS |
References
- DESTINY-Lung04: NCT05048797
Trastuzumab deruxtecan monotherapy
Regimen variant #1, 5.4 mg/kg
FDA-recommended dose |
Study | Dates of enrollment | Evidence |
---|---|---|
Goto et al. 2023 (DESTINY-Lung02) | 2021-03 to 2022-03 | Phase 2 (RT) |
Biomarker eligibility criteria
- HER2 mutations
Antibody-drug conjugate therapy
- Trastuzumab deruxtecan (Enhertu) 5.4 mg/kg IV once on day 1
21-day cycles
Regimen variant #2, 6.4 mg/kg
Study | Dates of enrollment | Evidence |
---|---|---|
Li et al. 2021 (DESTINY-Lung01) | 2018-2020 | Phase 2 |
Goto et al. 2023 (DESTINY-Lung02) | 2021-03 to 2022-03 | Phase 2 |
Biomarker eligibility criteria
- HER2 mutations
Antibody-drug conjugate therapy
- Trastuzumab deruxtecan (Enhertu) 6.4 mg/kg IV once on day 1
21-day cycles
References
- DESTINY-Lung01: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT03505710
- DESTINY-Lung02: Goto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, Ahn MJ, Smit EF, de Langen AJ, Pérol M, Pons-Tostivint E, Novello S, Hayashi H, Shimizu J, Kim DW, Kuo CH, Yang JC, Pereira K, Cheng FC, Taguchi A, Cheng Y, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. J Clin Oncol. 2023 Nov 1;41(31):4852-4863. Epub 2023 Sep 11. Erratum in: J Clin Oncol. 2023 Dec 19;:JCO2302574. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT04644237