Difference between revisions of "Non-small cell lung cancer, ROS1-positive"
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Guidelines= | =Guidelines= | ||
| − | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any | + | '''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]== | ==[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://www.ncbi.nlm.nih.gov/pubmed/35816666 PubMed] | *'''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://www.ncbi.nlm.nih.gov/pubmed/35816666 PubMed] | ||
==[https://www.esmo.org/ ESMO]== | ==[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://www.ncbi.nlm.nih.gov/pubmed/36872130 PubMed] | *'''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://www.ncbi.nlm.nih.gov/pubmed/36872130 PubMed] | ||
| − | == | + | ==NCCN== |
| − | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/ | + | *''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].'' |
=Advanced or metastatic disease, ROS1 inhibitor-naive= | =Advanced or metastatic disease, ROS1 inhibitor-naive= | ||
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<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:47c6e4|Variant=1}}=== | ===Regimen {{#subobject:47c6e4|Variant=1}}=== | ||
| − | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
| − | !style="width: | + | !style="width: 25%"|Study |
| − | !style="width: | + | !style="width: 25%"|Dates of enrollment |
| − | !style="width: | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| + | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
|[https://doi.org/10.1200/JCO.2016.71.3701 Lim et al. 2017] | |[https://doi.org/10.1200/JCO.2016.71.3701 Lim et al. 2017] | ||
| + | |2013-06-07 to 2016-02-01 | ||
| style="background-color:#91cf61" |Phase 2 | | style="background-color:#91cf61" |Phase 2 | ||
| style="background-color:#bfd3e6" |ORR: 67% (95% CI, 48-81) | | style="background-color:#bfd3e6" |ORR: 67% (95% CI, 48-81) | ||
| Line 97: | Line 99: | ||
===References=== | ===References=== | ||
# '''PROFILE 1001 ROS1:''' Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. [https://doi.org/10.1056/NEJMoa1406766 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25264305/ PubMed] [https://clinicaltrials.gov/study/NCT00585195 NCT00585195] | # '''PROFILE 1001 ROS1:''' Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. [https://doi.org/10.1056/NEJMoa1406766 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25264305/ PubMed] [https://clinicaltrials.gov/study/NCT00585195 NCT00585195] | ||
| − | ##'''Update:''' Shaw AT, Riely GJ, Bang YJ, Kim DW, Camidge DR, Solomon BJ, Varella-Garcia M, Iafrate AJ, Shapiro GI, Usari T, Wang SC, Wilner KD, Clark JW, Ou SI. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019 Jul 1;30(7):1121-1126. [https://doi.org/10.1093/annonc/mdz131 link to original article] [ | + | ##'''Update:''' Shaw AT, Riely GJ, Bang YJ, Kim DW, Camidge DR, Solomon BJ, Varella-Garcia M, Iafrate AJ, Shapiro GI, Usari T, Wang SC, Wilner KD, Clark JW, Ou SI. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019 Jul 1;30(7):1121-1126. [https://doi.org/10.1093/annonc/mdz131 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6637370/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30980071/ PubMed] |
==Entrectinib monotherapy {{#subobject:bcja91|Regimen=1}}== | ==Entrectinib monotherapy {{#subobject:bcja91|Regimen=1}}== | ||
| Line 153: | Line 155: | ||
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
| − | |[https:// | + | |[https://doi.org/10.1056/nejmoa2302299 Drilon et al. 2024 (TRIDENT-1)] |
| − | |2017- | + | |2017-02-27 to 2022-12-19 |
| style="background-color:#91cf61" |Phase 1/2 (RT) | | style="background-color:#91cf61" |Phase 1/2 (RT) | ||
|- | |- | ||
| Line 166: | Line 168: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''TRIDENT-1:''' [https://clinicaltrials.gov/study/NCT03093116 NCT03093116] | + | #'''TRIDENT-1:''' Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. [https://doi.org/10.1056/nejmoa2302299 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/38197815/ PubMed] [https://clinicaltrials.gov/study/NCT03093116 NCT03093116] |
=Advanced or metastatic disease, ROS1 inhibitor-exposed= | =Advanced or metastatic disease, ROS1 inhibitor-exposed= | ||
| Line 204: | Line 206: | ||
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
| − | |[https:// | + | |[https://doi.org/10.1056/nejmoa2302299 Drilon et al. 2024 (TRIDENT-1)] |
| − | |2017- | + | |2017-02-27 to 2022-12-19 |
| style="background-color:#91cf61" |Phase 1/2 (RT) | | style="background-color:#91cf61" |Phase 1/2 (RT) | ||
|- | |- | ||
| Line 217: | Line 219: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''TRIDENT-1:''' [https://clinicaltrials.gov/study/NCT03093116 NCT03093116] | + | #'''TRIDENT-1:''' Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. [https://doi.org/10.1056/nejmoa2302299 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/38197815/ PubMed] [https://clinicaltrials.gov/study/NCT03093116 NCT03093116] |
=Additional resources= | =Additional resources= | ||
Latest revision as of 19:47, 2 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.
6 regimens on this page
8 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.
Advanced or metastatic disease, ROS1 inhibitor-naive
Ceritinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Lim et al. 2017 | 2013-06-07 to 2016-02-01 | Phase 2 | ORR: 67% (95% CI, 48-81) |
Targeted therapy
- Ceritinib (Zykadia) 750 mg PO once per day on days 1 to 28, taken on an empty stomach
28-day cycles
References
- Lim SM, Kim HR, Lee JS, Lee KH, Lee YG, Min YJ, Cho EK, Lee SS, Kim BS, Choi MY, Shim HS, Chung JH, La Choi Y, Lee MJ, Kim M, Kim JH, Ali SM, Ahn MJ, Cho BC. Open-label, multicenter, phase II study of ceritinib in patients with non-small-cell lung cancer harboring ROS1 rearrangement. J Clin Oncol. 2017 Aug 10;35(23):2613-2618. Epub 2017 May 18. link to original article contains dosing details in manuscript PubMed NCT01964157
Crizotinib monotherapy
Regimen variant #1, standard-dose
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Shaw et al. 2014 (PROFILE 1001 ROS1) | 2010-2013 | Phase 1 (RT) | ORR: 72% (95% CI, 58-84) |
Note: this was an expansion cohort of a phase 1 study.
Regimen variant #2, 200 mg twice per day
| FDA-recommended dose |
Note: this is the FDA-recommended dosing for "moderate" hepatic impairment.
Regimen variant #3, 250 mg/day
| FDA-recommended dose |
Note: this is the FDA-recommended dosing for "severe" hepatic or renal impairment.
References
- PROFILE 1001 ROS1: Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00585195
- Update: Shaw AT, Riely GJ, Bang YJ, Kim DW, Camidge DR, Solomon BJ, Varella-Garcia M, Iafrate AJ, Shapiro GI, Usari T, Wang SC, Wilner KD, Clark JW, Ou SI. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019 Jul 1;30(7):1121-1126. link to original article link to PMC article PubMed
Entrectinib monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2017 (ALKA-372-001) | 2012-2018 | Phase 1 (RT) |
| Drilon et al. 2017 (STARTRK-1) | 2012-2018 | Phase 1 (RT) |
Note: this is the MTD used in the phase 2 portion; it is also the FDA-recommended dose for adults.
References
- ALKA-372-001: Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. link to original article link to PMC article contains dosing details in manuscript PubMed EudraCT 2012-000148-88
- Pooled update: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Erratum in: Lancet Oncol. 2020 Jul;21(7):e341. link to original article link to PMC article PubMed
- Pooled update: Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. Epub 2021 Mar 1. link to original article link to PMC article PubMed
- STARTRK-1: Drilon A, Siena S, Ou SI, Patel M, Ahn MJ, Lee J, Bauer TM, Farago AF, Wheler JJ, Liu SV, Doebele R, Giannetta L, Cerea G, Marrapese G, Schirru M, Amatu A, Bencardino K, Palmeri L, Sartore-Bianchi A, Vanzulli A, Cresta S, Damian S, Duca M, Ardini E, Li G, Christiansen J, Kowalski K, Johnson AD, Patel R, Luo D, Chow-Maneval E, Hornby Z, Multani PS, Shaw AT, De Braud FG. Safety and antitumor activity of the multitargeted pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I trials (ALKA-372-001 and STARTRK-1). Cancer Discov. 2017 Apr;7(4):400-409. Epub 2017 Feb 9. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02097810
- Pooled update: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Erratum in: Lancet Oncol. 2020 Jul;21(7):e341. link to original article link to PMC article PubMed
- Pooled update: Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. Epub 2021 Mar 1. link to original article link to PMC article PubMed
Repotrectinib monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2024 (TRIDENT-1) | 2017-02-27 to 2022-12-19 | Phase 1/2 (RT) |
Targeted therapy
- Repotrectinib (Augtyro) as follows:
- Cycle 1: 160 mg PO once per day on days 1 to 14, then 160 mg PO twice per day on days 15 to 28
- Cycle 2 onwards: 160 mg PO twice per day on days 1 to 28
28-day cycles
References
- TRIDENT-1: Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. link to original article contains dosing details in abstract PubMed NCT03093116
Advanced or metastatic disease, ROS1 inhibitor-exposed
Lorlatinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Shaw et al. 2017 (B7461001) | 2014-2016 | Phase 1/2 |
References
- B7461001: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. Epub 2017 Oct 23. link to original article contains dosing details in abstract link to PMC article PubMed NCT01970865
- Update: Shaw AT, Solomon BJ, Chiari R, Riely GJ, Besse B, Soo RA, Kao S, Lin CC, Bauer TM, Clancy JS, Thurm H, Martini JF, Peltz G, Abbattista A, Li S, Ou SI. Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2019 Dec;20(12):1691-1701. Epub 2019 Oct 25. link to original article PubMed
Repotrectinib monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Drilon et al. 2024 (TRIDENT-1) | 2017-02-27 to 2022-12-19 | Phase 1/2 (RT) |
Targeted therapy
- Repotrectinib (Augtyro) as follows:
- Cycle 1: 160 mg PO once per day on days 1 to 14, then 160 mg PO twice per day on days 15 to 28
- Cycle 2 onwards: 160 mg PO twice per day on days 1 to 28
28-day cycles
References
- TRIDENT-1: Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. link to original article contains dosing details in abstract PubMed NCT03093116