A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed,Stage III Subjects With Locally Advanced,Unresectable Non-small Cell Lung Cancer (RATIONALE001)
研究单位:[1]Celgene[2]Sichuan Cancer Hospital & Institute Chengdu,China,610041[3]Foshan First People's Hospital Foshan,China,528000[4]Fujian Medical University - Fujian Provincial Cancer Hospital Fuzhou Shi,China,350014[5]Cancer Center of Guangzhou Medical University Guangzhou,China,510095[6]The First Affiliated Hospital of Guangzhou Medical University Guangzhou,China,510120[7]Zhejiang University School of Medicine - The Second Affiliated Hospital Hangzhou,China,310016[8]Zhejiang Medical University - Zhejiang Cancer Hospital Hangzhou,China,310022[9]The First Affiliated Hospital of Harbin Medical University Harbin,China,150081[10]Yunnan Cancer Hospital Kunming Shi,China,650118
研究目的:
This is a Phase 3,randomized,double-blind,placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone,and tislelizumab given sequentially after cCRT versus cCRT alone,in newly diagnosed stage III subjects with locally advanced,unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .