Spots Global Cancer Trial Database for Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
Official Title: Multicenter, Open-label, Phase II Study With a Safety Lead-in Part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer Who Are BRAF- and MEK Inhibitor Treatment-naïve
Study ID: NCT05195632
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, , China
Beijing Chest Hospital, Capital Medical University, Beijing, , China
Peking University First Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun, , China
Xiangya Hospital Central South University, Changsha, , China
Sichuan Cancer Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
The Second Hospital of Dalian University, Dalian, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian), Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Hainan General Hospital, Haikou, , China
First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, , China
Linyi Cancer Hospital, Linyi, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
The First Hospital of China Medical University, Shenyang, , China
Peking University Shenzhen Hospital, Shenzhen, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
Shanxi Provincial Cancer Hospital, Taiyuan, , China
Tianjin Cancer Hospital Airport Hospital, Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Union Hospital Tongji medical college Huazhong University of Science and Technology, Wuhan, , China
The Northern Jiangsu People's Hospital, Yangzhou, , China
Yantai Yuhuangding Hospital, Yantai, , China
Henan Cancer Hospital, Zhengzhou, , China
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Li Zhang, MD
Affiliation: Sun Yat-sen Univ. Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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