A trial to evaluate whether the combination encorafenib and binimetinib is safe and effective in Chinese participants with BRAFV600E lung cancer
A trial to evaluate whether the combination encorafenib and binimetinib is safe and effective in Chinese participants with BRAFV600E lung cancer
Multicenter, Open-label, Phase II Study with a Safety Lead-in part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAFV600E mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer who are BRAF- and MEK inhibitor treatment-naïve
Brief summary
At the time of the initiation of the OCEAN II trial, there was no therapy available in China for the treatment of patients with lung cancer targeting the specific genetic mutation called BRAFV600E mutation.
The combination of encorafenib and binimetinib is a marketed therapy (Braftovi® and Mektovi®) approved to treat patients with certain skin cancer (melanoma) in several countries (European Union, USA, Australia, Japan, Switzeland...).
Data of previous clinical studies have shown that the same type (BRAF and MEK inhibitors) is effective for lung cancer.
This trial is a two-part trial to evaluate whether the combination of encorafenib and binimetinib is safe and effective in a specific group of metastatic BRAFV600E mutated lung cancer (non-small cell lung cancer) in Chinese participants.
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