RecruitingPhase 3NCT07010263

A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

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

Sponsor

Akeso

Enrollment

560 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called AK112 as a maintenance (consolidation) treatment for patients with limited-stage small cell lung cancer whose disease has not worsened after completing combined chemotherapy and radiation therapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with limited-stage small cell lung cancer (confined to one side of the chest) - Your cancer did not progress during or after chemoradiation therapy - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to the brain (unless treated and stable) - You have an active autoimmune disease or are taking long-term steroids - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK112

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

OTHERPlacebo

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

Liuzhou, 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

View Full Details on ClinicalTrials.gov

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NCT07010263

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