OncRef

Clinical Trial: NCT05195632

Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Pierre Fabre Medicament
Information Provided By:Pierre Fabre Medicament
Last Update Posted:2026-05-01

Study Overview

Brief Summary

This is a phase 2, multicenter, single-arm study with a safety lead-in to investigate the efficacy, safety and pharmacokinetics of encorafenib 450 mg once daily (QD) in combination with binimetinib 45 mg twice daily (BID) (Combo450) in adult Chinese participants with metastatic unresectable stage IV BRAF V600E mutant NSCLC, who are BRAF- and MEK-inhibitor treatment-naïve and are either previously untreated or have had one line of prior therapy in metastatic setting.

Official Title

Multicenter, Open-label, Phase II Study With a Safety Lead-in Part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer Who Are BRAF- and MEK Inhibitor Treatment-naïve

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Encorafenib
  • Drug: Binimetinib

Other Study ID Numbers

  • W00090GE203
  • CTR20212962
  • CTR20212961

Start Date (Actual)

2022-06-02

Primary Completion Date (Actual)

2024-05-27

Study Completion Date (Estimated)

2026-12-14

Enrollment (Actual)

63

Study Type

Interventional

Phase

Phase 2