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Brief Title: A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy
Study ID: NCT04308785
Brief Summary: This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.
Detailed Description: Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hu Nan Provincial Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital, Chengdu City, , China
Southwest Hospital , Third Military Medical University, Chongqing, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Cancer Hospital, Hefei City, , China
Shandong Cancer Hospital, Jinan, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning, , China
Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai City, , China
Tianjin Cancer Hospital, Tianjin, , China
Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Henan Cancer Hospital, Zhengzhou, , China
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR