Non-small cell lung cancer, BRAF-mutated

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Eric K. Singhi, MD
MD Anderson Cancer Center
Houston, TX

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Amit Kulkarni, MBBS
University of Minnesota
Minneapolis, MN

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Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.

2 regimens on this page
2 variants on this page


Advanced or metastatic disease, first-line

Dabrafenib & Trametinib

Regimen

FDA-recommended dose
Study Years of enrollment Evidence
Planchard et al. 2017 (BRF113928 untreated) 2014-2015 Phase 2 (RT)

Biomarker eligibility criteria

  • Biomarker: BRAF V600E

Targeted therapy

Continued indefinitely

References

  1. 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
    1. 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

Dabrafenib & Trametinib

Regimen

FDA-recommended dose
Study Years 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

Continued indefinitely

References

  1. 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 contains dosing details in manuscript link to PMC article PubMed NCT01336634
    1. 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