CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
encorafenib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed stage IV NSCLC
  • BRAFV600 mutation (V600E or other variants K or D)
  • Treatment-naïve OR prior platinum-based chemotherapy OR prior PD-1/PD-L1 inhibitor (given alone or with platinum)
  • Measurable disease per RECIST v1.1
Key exclusion· 8
  • EGFR mutation, ALK fusion, or ROS1 rearrangement
  • More than 1 prior line of systemic therapy in advanced/metastatic setting
  • Prior BRAF inhibitor or MEK inhibitor
  • Impaired cardiovascular function or clinically significant cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03915951
NCT03915951Phase 2Completed

A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer

Pfizer·interventional·Posted Apr 16, 2019·Updated Mar 24, 2026

In Brief

A Phase 2 clinical trial evaluating encorafenib and binimetinib for Non-small Cell Lung Cancer. Completed, enrolled 98 participants across 143 sites in 5 countries.

Detailed Summary

This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, Netherlands, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartJun 4, 2019
Primary CompletionSep 22, 2022
Study CompletionOct 3, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.2 years ago

Interventions

encorafenibdrug

self-administered orally

binimetinibdrug

self-administered orally