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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

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研究单位： [1]Celgene [2]Fudan University Shanghai Cancer Center Shanghai, China, 200032 [3]Chongqing Cancer Hospital Shapingbaqu, China, 400030 [4]Liaoning Cancer Hospital & Institute Shenyang Shi, China, 110042 [5]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, China, 430022 [6]Zhongnan Hospital of Wuhan University Wuhan, China, 430023 [7]The First Affiliated Hospital of Xi'an Jiaotong University Xi'an City, China, 710061 [8]Tampereen yliopistollinen sairaala Tampere, Finland, 33521 [9]Centre Francois Baclesse Caen Cedex 5, France, 14076 [10]Medical Study Company NORD-WEST GmbH Oncology Aurich Aurich, Germany, 26603

关键词： Locally Advanced Unresectable Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer NSCLC Randomized BGB-A317 Tislelizumab PD-1

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