Non-small cell lung cancer, ROS1-positive
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| Section editor | |
|---|---|
 |
Travis Osterman, DO, MS Nashville, TN Twitter: TravisOsterman |
Note: these are biomarker-specific regimens, please see the main NSCLC page for other regimens.
6 regimens on this page
8 variants on this page
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Advanced or metastatic disease, ROS1 inhibitor-naive
Ceritinib monotherapy
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Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Lim et al. 2017 | Phase II | ORR: 67% (95% CI, 48-81) |
Chemotherapy
- Ceritinib (Zykadia) 750 mg PO once per day 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 verified protocol PubMed
Crizotinib monotherapy
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Variant #1, standard-dose
| FDA-recommended dose |
| Study | Evidence | Efficacy |
|---|---|---|
| Shaw et al. 2014 (PROFILE 1001) | Non-randomized | ORR: 72% (95% CI, 58-84) |
Note: this was an expansion cohort of a phase I study.
Chemotherapy
- Crizotinib (Xalkori) 250 mg PO BID
28-day cycles
Variant #2, 200 mg BID
| FDA-recommended dose |
Note: this is the FDA-recommended dosing for "moderate" hepatic impairment.
Chemotherapy
- Crizotinib (Xalkori) 200 mg PO BID
Continued indefinitely
Variant #3, 250 mg/d
| FDA-recommended dose |
Note: this is the FDA-recommended dosing for "severe" hepatic or renal impairment.
Chemotherapy
- Crizotinib (Xalkori) 250 mg PO once per day
Continued indefinitely
References
- PROFILE 1001: 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 verified protocol PubMed
Advanced or metastatic disease, ROS1 inhibitor-exposed
Lorlatinib monotherapy
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Regimen
| Study | Evidence |
|---|---|
| Shaw et al. 2017 (B7461001) | Phase I, <20 pts in this subgroup |
Chemotherapy
- Lorlatinib (Lorbrena) 100 mg PO once per day
Continued indefinitely
References
- Phase 1: 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 protocol PubMed
Additional resources
Investigational agents
Drugs with some degree of promising activity in clinical trials.