Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer (OCEANII)
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研究单位：[1]Pierre Fabre Medicament[2]Beijing Chest Hospital, Capital Medical University Beijing, China[3]Peking University First Hospital Beijing, China[4]The First Hospital of Jilin University Changchun, China[5]Xiangya Hospital Central South University Changsha, China[6]Sichuan Cancer Hospital Chengdu, China[7]Chongqing University Cancer Hospital Chongqing, China[8]The Second Hospital of Dalian University Dalian, China[9]Fujian Medical University Union Hospital Fuzhou, China[10]Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian) Fuzhou, China[11]Guangdong Provincial People's Hospital Guangzhou, China[12]Sun Yat-sen University Cancer Center Guangzhou, China[13]Hainan General Hospital Haikou, China[14]First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, China[15]Zhejiang Cancer Hospital Hangzhou, China[16]Zhejiang University School of Medicine, Sir Run Run Shaw Hospital Hangzhou, China[17]Harbin Medical University Cancer Hospital Harbin, China[18]Shandong Cancer Hospital Jinan, China[19]The First Affiliated Hospital of Jinzhou Medical University Jinzhou, China[20]Linyi Cancer Hospital Linyi, China[21]The First Affiliated Hospital of Nanchang University Nanchang, China[22]Guangxi Medical University Affiliated Tumor Hospital Nanning, China[23]Fudan University Shanghai Cancer Center Shanghai, China[24]Liaoning Cancer Hospital & Institute Shenyang, China[25]The First Hospital of China Medical University Shenyang, China[26]Peking University Shenzhen Hospital Shenzhen, China[27]The Fourth Hospital of Hebei Medical University Shijiazhuang, China河北医科大学第四医院[28]Shanxi Provincial Cancer Hospital Taiyuan, China[29]Tianjin Cancer Hospital Airport Hospital Tianjin, China[30]Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, China[31]Union Hospital Tongji medical college Huazhong University of Science and Technology Wuhan, China[32]The Northern Jiangsu People's Hospital Yangzhou, China[33]Yantai Yuhuangding Hospital Yantai, China[34]Henan Cancer Hospital Zhengzhou, China[35]National Taiwan University Hospital Taipei, Taiwan[36]Taipei Veterans General Hospital Taipei, Taiwan[37]Beijing Cancer Hospital Beijing, China
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.
