Clinical Trial

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

Study acronym: OCEANII
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2022-01-04; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2023-10-25
Status change: Not Yet Recruiting → Recruiting 2022-05-12
Trial Details
NCT Number NCT05195632
Lead Sponsor Pierre Fabre Medicament
Conditions Non-Small Cell Lung Cancer
Enrollment 63 participants
Start Date 2022-06-02
Primary Completion 2024-05-27 (estimated)
Study Completion 2026-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-05-01