A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
AK112: AK112 20mg/kg, intravenous \[IV\]),Q3W
Placebo: Placebo, intravenous \[IV\]),Q3W
Study 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
Primary outcome measure(s)
- Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC) — Approximately 6 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1 - Overall Survival (OS) — Approximately 6 years
OS is defined as the time from randomization or first dosing to death due to any cause.
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Medical Center of Chinese PLA General Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Chest Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijin | Beijin | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Recruiting |
| PLA No. 900 Hospital of the Joint Support Force | Fuzhou | Fujian | Recruiting |
| Longyan First Hospital | Longyan | Fujian | Recruiting |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | Recruiting |
| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | Recruiting |
| Jiangmen Central Hospital | Jiangmen | Guangdong | Recruiting |
| Liuzhou People's Hospital | Liuzhou | Guangxi | Recruiting |
| Affiliated Cancer Hospital of Guangxi Medical University | Nanning | Guangxi | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangzhou | Recruiting |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | Recruiting |
| The Second Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| Tangshan People's Hospital | Tangshan | Hebei | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Recruiting |
| Anyang Cancer Hospital | Anyang | Henan | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Jingzhou First People's Hospital | Jingzhou | Hubei | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| The First Affiliated Hospital of South China University | Hengyang | Hunan | Recruiting |
| General Hospital of the PLA Eastern Theater Command | Nanjing | Jiangsu | Recruiting |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | Recruiting |
| Xuzhou Municipal Hospital | Xuzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital of Gannan Medical University | Gannan | Jiangxi | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| Jilin Cancer Hospital | Changchun | Jilin | Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| Ningxia Medical University General Hospital | Yinchuan | Ningxia | Recruiting |
| Shandong Provincial Hospital | Jinan | Shandong | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
+ 13 more sites — see the full list on the official registry below.
More Akeso trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07010263 on ClinicalTrials.gov ↗ ← All trials in China