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RECRUITING
NCT07010263
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

AK112

AK112 20mg/kg, intravenous \[IV\]),Q3W

OTHER

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