Non-small cell lung cancer, BRAF-mutated
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| 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:
| Last updated on 2024-07-23: 3 regimens on this page
3 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.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Non-Small Cell Lung Cancer.
Advanced or metastatic disease, first-line
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2017 (BRF113928 untreated) | 2014-2015 | Phase 2 (RT) |
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 untreated: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. link to original article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed
Advanced or metastatic disease, previously treated, BRAF inhibitor-naive
Binimetinib & Encorafenib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Riely et al. 2023 (PHAROS) | 2019-06-04 to 2022-06-02 | Phase 2 (RT) |
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Binimetinib (Mektovi) 45 mg PO twice per day on days 1 to 28
- Encorafenib (Braftovi) 450 mg PO once per day on days 1 to 28
28-day cycles
References
- PHAROS: Riely GJ, Smit EF, Ahn MJ, Felip E, Ramalingam SS, Tsao A, Johnson M, Gelsomino F, Esper R, Nadal E, Offin M, Provencio M, Clarke J, Hussain M, Otterson GA, Dagogo-Jack I, Goldman JW, Morgensztern D, Alcasid A, Usari T, Wissel P, Wilner K, Pathan N, Tonkovyd S, Johnson BE. Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Jul 20;41(21):3700-3711. Epub 2023 Jun 4. Erratum in: J Clin Oncol. 2023 Dec 5;:JCO2302518. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03915951
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2016 (BRF113928 previously treated) | 2013-2015 | Phase 2 (RT) |
Prior treatment criteria
- 1 to 3 prior regimens, with progression
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 previously treated: Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed