Encorafenib 75 MG / Binimetinib 15 MG / BRAF V600E · Phase 2 Trial

ENCOrafenib With Binimetinib in bRAF NSCLC

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 registration for a combination BRAF and MEK inhibitor trial in BRAF V600E-mutant metastatic NSCLC. No results are yet posted in this registry record, and the study remains active but not recruiting. Any assessment of efficacy or clinical utility must await peer-reviewed publication of primary endpoint data.

What was studied

Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Non Small Cell Lung Cancer, BRAF V600E; age from 18 Years. Intervention: Cohort 1 (1st line); Cohort 2 (2nd line). n = 119. 36 sites: France.

Key findings

Safety

This is a registry record only; no efficacy, safety, or outcome data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registration with no reported results; the study is active but not yet recruiting, so efficacy and safety data are not yet available for clinical assessment.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Objective response rate (assessed at 6 months)

DesignPhase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose

PopulationNon Small Cell Lung Cancer, BRAF V600E; age from 18 Years

Sample size119

InterventionCohort 1 (1st line); Cohort 2 (2nd line)

Setting36 sites: France

Reported figures

Quoted from the source exactly as published.

Phase2

Estimated enrollment119

Primary outcome measureObjective response rate at 6 months

Intervention dose: Encorafenib75 mg

Intervention dose: Binimetinib15 mg

Caveats

This is a registry record only; no efficacy, safety, or outcome data are reported.
Study arm structure (single-arm vs. comparative) is not specified in the registry entry.
Recruitment status is 'active, not recruiting,' so results may not yet be available.
Primary endpoint timing (6 months) and response criteria are noted but no results are posted.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design; single-arm or comparative structure not specified in registry.

Directness

strong

Targets BRAF V600E-mutant metastatic NSCLC with direct BRAF/MEK inhibitor combination.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry entry alone.

Risk of bias

insufficient

Blinding, allocation concealment, and other methodological details not stated in registry.

Sample adequacy

moderate

Estimated enrollment 119 participants; adequacy for Phase 2 objective response endpoint unclear.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04526782). This is a study registration, not published results. Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 119 participants (ESTIMATED). Conditions: Non Small Cell Lung Cancer, BRAF V600E. Interventions: DRUG: Encorafenib 75 MG; DRUG: Binimetinib 15 MG. Primary outcome measures: Objective response rate , 6 months. Brief summary: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Encorafenib 75 MGBinimetinib 15 MGIntergroupe Francophone de Cancerologie ThoraciqueBRAF V600ENCT04526782Non Small Cell Lung Cancer