A phase 2 study of encorafenib in combination with binimetinib for Chinese participants with BRAF V600E mutated metastatic non-small cell lung cancer: Results from the OCEAN II study
Published report from the OCEANII trial registered as NCT05195632, in Lung cancer (2026), chosen as the most cited paper whose own text cites the registry id.
Overview
Purpose: The ongoing OCEAN II study (ClinicalTrials.gov identifier: NCT05195632) evaluates encorafenib in combination with binimetinib (E+B) in Chinese participants with BRAF V600E -mutated metastatic non-small cell lung cancer (NSCLC).
Methods: Participants with metastatic unresectable stage IV BRAF V600E -mutated NSCLC (treatment-naïve or with prior systemic therapy excluding BRAF/MEK-inhibitors), were enrolled in a phase 2 study with two parts: safety lead-in (SLI) and pivotal part (PP). Participants received daily oral encorafenib (450mg) and twice daily oral binimetinib (90mg total). Primary endpoints were dose-limiting toxicities (DLT) during SLI and confirmed objective response rate by independent central review (cORR-ICR) during PP. Secondary endpoints were other measures of efficacy, safety, and pharmacokinetics.
Results: In total, 63 participants were enrolled. One DLT (non-serious Grade 3 lipase increased) during SLI considered possibly related to E+B resolved without intervention, supporting initiation of PP. Pre-defined statistical efficacy criteria on the first 50 participants were met. In the main analysis, cORR-ICRwas59% (95%CI 45-72). At a later ad hoc analysis, cORR-ICR was 61% (95%CI 47-74), disease control rate 87% (95%CI 75-95). Medians (95%CI) were, time-to-response 1.8 months, duration of response 17.5 months, progression-free survival 13.8 months (7.5-not estimable), overall survival 27.9 months (14.7-30.0). 98.4% of participants experienced ≥1 treatment-related TEAE, and 55.6% had any Grade ≥3 TEAE. Nine (14.3%) participants discontinued any drug due to adverse events.
Conclusion: These data confirm the clinical benefit of E+B in Chinese participants with BRAF V600E -mNSCLC, a population with distinct genomic and disease characteristics. No new safety concerns were identified in Chinese participants.
Indexed on Europe PMC as PubMed record 42612509 (DOI 10.1016/j.lungcan.2026.109580). Its abstract cites the registry id NCT05195632, which is how it was matched to this trial; no figure has been checked by an editor.
This is the paper Europe PMC returns for registry id NCT05195632 with the most citations, so it is the natural first reading for anyone following the OCEANII trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.