A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
AK112-311
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
1 other identifier
interventional
560
1 country
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Typical duration for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
March 5, 2026
March 1, 2026
3.6 years
May 25, 2025
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC)
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
Approximately 6 years
Overall Survival (OS)
OS is defined as the time from randomization or first dosing to death due to any cause.
Approximately 6 years
Secondary Outcomes (8)
PFS assessed by investigator per RECIST v1.1
Approximately 6 years
Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1
Approximately 6 years
ORR assessed by investigator Per RECIST v1.1
Approximately 6 years
Disease control rate(DCR) assessed by BICR per RECIST v1.1
Approximately 6 years
DCR assessed by investigator per RECIST v1.1
Approximately 6 years
- +3 more secondary outcomes
Study Arms (2)
Ak112 arm
EXPERIMENTALAK112 intravenous \[IV\]),every 3 weeks
Placebo arm
PLACEBO COMPARATORPlacebo intravenous \[IV\]),every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
- Aged ≥18 years on day fo signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months
- Histologically or cytologically confirmed small cell lung cancer.
- Documented limited-stage SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\] or the Veterans Administration Lung Study Group (VALG) stage.
- Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy.
- Adequate organ function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.
You may not qualify if:
- Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
- Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
- Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
- History of active malignant tumors within the previous 5 years.
- Received major surgery within 28 days prior to the first dose of study drug, or expected to undergo major surgery during the study period within 28 days after the first dose of study drug.
- Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, and other related diseases..
- Have serious neurological or mental illnesses, including dementia and epileptic seizures.
- Pregnant or lactating women.
- Have cardiovascular or cerebrovascular diseases or risk factors.
- Prior treatments with systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration of the study drugs. Prior treatment with Chinese herbal medicine or traditional Chinese patent medicines with anti-tumor indications within 1 weeks before the first administration of the study drugs.
- Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy.
- Prior treatments with anti-angiogenic therapy.
- Subjects requiring systemic treatment with corticosteroids (\>10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
- Known history of severe hypersensitivity reactions to other monoclonal antibodies or with a known history of allergy or hypersensitivity reactions to any of study drugs or their components.
- Active autoimmune diseases that require systemic treatment within 2 years prior to the study, or autoimmune diseases that the investigator judges to be potentially recurrent or require planned treatment.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (53)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijin, Beijin, 100021, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
PLA No. 900 Hospital of the Joint Support Force
Fuzhou, Fujian, 350025, China
Longyan First Hospital
Longyan, Fujian, 364000, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, 510080, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 400042, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Tangshan People's Hospital
Tangshan, Hebei, 063001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of South China University
Hengyang, Hunan, 421001, China
General Hospital of the PLA Eastern Theater Command
Nanjing, Jiangsu, 210002, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Xuzhou Municipal Hospital
Xuzhou, Jiangsu, 221002, China
The First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, 341000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
Qingdao Central Hospital of Health and Rehabilitation Sciences University
Qingdao, Shandong, 266000, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100, China
Weifang No.2 People's Hospital
Weifang, Shangdong, 261041, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 300013, China
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi, 710038, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Xi'an Jiaotong University
Shaxi, Xi'an, 710061, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2025
First Posted
June 8, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
July 31, 2029
Last Updated
March 5, 2026
Record last verified: 2026-03