At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed NSCLC Stage IV
- ✓Cohorts A & B: prior progression after ≥1 platinum-based chemotherapy regimen (or alternate if intolerant); Cohort B: ≤3 prior systemic treatments for metastatic disease; Cohort C: no prior systemic therapy for metastatic disease
- ✓Measurable disease per RECIST 1.1
- ✓BRAF V600E mutation confirmed in CLIA-certified laboratory with adequate tumor tissue available for central validation
- ✕Prior treatment with any BRAF inhibitor (dabrafenib, vemurafenib, LGX818, XL281/BMS-908662) or MEK inhibitor (trametinib, AZD6244, RDEA119) — exception: prior dabrafenib allowed for Cohort A crossover subjects
- ✕Anti-cancer therapy within 14 days prior to start of study treatment (exception: dabrafenib monotherapy within 14 days allowed for Cohort A crossover)
- ✕Investigational anti-cancer drug within 14 days or 5 half-lives (min 14 days) prior to study start (exception: dabrafenib monotherapy allowed for Cohort A crossover)
- ✕Unresolved Grade ≥2 toxicity from prior anti-cancer therapy (except alopecia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Dabrafenib and Trametinib for Cancer. Completed, enrolled 177 participants across 50 sites in 11 countries.
Detailed Summary
This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.
Study Details
Timeline
Interventions
Dabrafenib study treatment was provided as 50 mg and 75 mg hydroxypropyl methylcellulose (HPMC) capsules. Each capsule contains 50 mg or 75 mg of free base (present as the mesylate salt)
Trametinib study treatment was provided as 0.5 mg and 2 mg tablets. Each tablet contained 0.5 mg or 2 mg of trametinib parent (present as the dimethyl sulfoxide solvate)