Actively Recruiting
A Study of AK112 Compared to Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer After Concurrent Chemoradiation Therapy
Led by Akeso · Updated on 2026-03-05
560
Participants Needed
53
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AK112, a PD-1/VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups: one receiving AK112 at a dose of 20 mg/kg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.
CONDITIONS
Brief Title
A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who voluntarily provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed small cell lung cancer
- Limited-stage small cell lung cancer (Stage I-III, M0) as defined by AJCC 8th Edition or VALG staging
- Completed concurrent chemoradiotherapy and have not progressed after treatment
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to effective contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Presence of mixed small cell lung cancer or non-small cell lung cancer components
- Unresolved toxicities from prior anti-tumor treatments above grade 1 except alopecia
- Clinically unacceptable disease deterioration such as cachexia
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- History of active malignant tumors within past 5 years
- Major surgery within 28 days before first dose or planned surgery within 28 days after first dose
- Uncontrolled comorbid conditions including severe liver, kidney, metabolic, or gastrointestinal diseases
- Serious neurological or mental illnesses including dementia or seizures
- Pregnant or breastfeeding women
- Cardiovascular or cerebrovascular diseases or risk factors
- Prior systemic non-specific immunomodulatory therapy within 2 weeks before first dose
- Prior immune-targeting treatments including checkpoint inhibitors or immune cell therapy
- Prior anti-angiogenic therapy
- Need for systemic corticosteroids or immunosuppressants above specified doses within 14 days before first dose
- Known severe hypersensitivity to monoclonal antibodies or study drug components
- Active autoimmune diseases requiring systemic treatment within 2 years or judged recurrent
- Known interstitial lung disease or non-infectious pneumonia requiring corticosteroids
- Severe infection within 4 weeks prior to first dose, active tuberculosis, syphilis, or immunodeficiency
- History of allogeneic organ or stem cell transplantation
- Active hepatitis B or C
- Receipt of live vaccine within 30 days before first dose or planned during study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately up to 6 years
Participants receive AK112 or placebo as consolidation treatment through intravenous infusion every 3 weeks.
Infusions every 3 weeks
Trial Site Locations
Total: 53 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
3
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
4
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
5
Cancer Hospital, Chinese Academy of Medical Sciences
Beijin, Beijin, China, 100021
Actively Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
7
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
8
PLA No. 900 Hospital of the Joint Support Force
Fuzhou, Fujian, China, 350025
Actively Recruiting
9
Longyan First Hospital
Longyan, Fujian, China, 364000
Actively Recruiting
10
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China, 363000
Actively Recruiting
11
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
12
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529030
Actively Recruiting
13
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545006
Actively Recruiting
14
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
15
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
16
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China, 510080
Actively Recruiting
17
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 400042
Actively Recruiting
18
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
Actively Recruiting
19
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
20
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Actively Recruiting
21
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
22
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
Actively Recruiting
23
Anyang Cancer Hospital
Anyang, Henan, China, 455000
Actively Recruiting
24
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Actively Recruiting
25
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
26
Jingzhou First People's Hospital
Jingzhou, Hubei, China, 434000
Actively Recruiting
27
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
28
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
29
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
30
The First Affiliated Hospital of South China University
Hengyang, Hunan, China, 421001
Actively Recruiting
31
General Hospital of the PLA Eastern Theater Command
Nanjing, Jiangsu, China, 210002
Actively Recruiting
32
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
33
Xuzhou Municipal Hospital
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
34
The First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China, 341000
Actively Recruiting
35
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
36
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
37
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
38
Ningxia Medical University General Hospital
Yinchuan, Ningxia, China, 750004
Actively Recruiting
39
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
40
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
41
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
42
Linyi People's Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
43
Qingdao Central Hospital of Health and Rehabilitation Sciences University
Qingdao, Shandong, China, 266000
Actively Recruiting
44
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China, 277100
Actively Recruiting
45
Weifang No.2 People's Hospital
Weifang, Shangdong, China, 261041
Actively Recruiting
46
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
47
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
48
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 300013
Actively Recruiting
49
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China, 710038
Actively Recruiting
50
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
51
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
52
The First Affiliated Hospital of Xi'an Jiaotong University
Shaxi, Xi'an, China, 710061
Actively Recruiting
53
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Z
Zhifang Yao, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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