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A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Sponsor: Akeso
Summary
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.
Official title: A Multicenter, Randomized, Double-blind, Phase III Clinical Study of Comparing the Efficacy and Safety of AK112 (PD-1/VEGF Bispecific Antibody) Versus Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
560
Start Date
2025-06-13
Completion Date
2029-07-31
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
AK112
AK112 20mg/kg, intravenous \[IV\]),Q3W
Placebo
Placebo, intravenous \[IV\]),Q3W
Locations (53)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijin, Beijin, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
PLA No. 900 Hospital of the Joint Support Force
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan People's Hospital
Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of South China University
Hengyang, Hunan, China
General Hospital of the PLA Eastern Theater Command
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Xuzhou Municipal Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Ningxia Medical University General Hospital
Yinchuan, Ningxia, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Central Hospital of Health and Rehabilitation Sciences University
Qingdao, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Weifang No.2 People's Hospital
Weifang, Shangdong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Shaxi, Xi'an, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China