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Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
MinorCompletion date: Sep 5, 2026 to Dec 14, 2026v20
MinorPrimary completion date changed from estimate of May 2025 to May 27, 2024Completion date: May 2025 to Sep 5, 2026v19Show 1 more changeShow less
Completion date: May 2025 to Sep 5, 2026
MinorRe-verified, no change to tracked fieldsv18
MinorStudy Identification, Study Statusv17
Show 15 earlier versionsHide 15 earlier versions
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 55 to confirmed 63 · Primary and study completion dates: Mar 2025 to May 2025 · Site details revised at 34 of 34 sitesv16Show 3 more changesShow less
Enrollment target: estimated 55 to confirmed 63
Primary and study completion dates: Mar 2025 to May 2025
Site details revised at 34 of 34 sites
MinorSite details revised at 1 of 34 sitesv15
MinorStudy sites: 35 to 34v14
MinorSecondary endpoints: details revised at 27 of 51 entriesv13
MinorStudy sites: 36 to 35v12
MinorSite details revised at 2 of 36 sitesv11
MinorSite details revised at 2 of 36 sitesv10
MinorSite details revised at 5 of 36 sitesv9
MinorSite details revised at 2 of 36 sitesv8
MinorSite details revised at 2 of 36 sitesv7
MinorSite details revised at 8 of 36 sitesv6
MinorSite details revised at 3 of 36 sitesv5
MinorStart date changed from estimate of May 2022 to Jun 2, 2022Study sites revised (36)v4Show 1 more changeShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 35 to 36 · Start date: Apr 2022 to May 2022v3Show 2 more changesShow less
Study sites: 35 to 36
Start date: Apr 2022 to May 2022
NotableStart date: Feb 2022 to Apr 2022Study sites: 36 to 35 · Primary and study completion dates: Dec 2024 to Mar 2025v2Show 2 more changesShow less
Study sites: 36 to 35
Primary and study completion dates: Dec 2024 to Mar 2025
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.