Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer (OCEANII)
研究单位:[1]Pierre Fabre Medicament[2]Chongqing University Cancer Hospital Chongqing,China[3]Sichuan Cancer Hospital Chengdu,China[4]Fujian Medical University Union Hospital Fuzhou,China[5]Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian) Fuzhou,China[6]Guangdong Provincial People's Hospital Guangzhou,China[7]Sun Yat-sen University Cancer Center Guangzhou,China[8]Hainan General Hospital Haikou,China[9]First Affiliated Hospital,Zhejiang University School of Medicine Hangzhou,China[10]Zhejiang Cancer Hospital Hangzhou,China
研究目的:
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.