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)

March 4, 2026 updated by: Akeso

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijin
      • Beijin, Beijin, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Zhijie Wang, M.D.
        • Principal Investigator:
          • Zhijie Wang, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital
        • Contact:
          • Rong Yu, M.D.
        • Principal Investigator:
          • Rong Yu, M.D.
      • Beijing, Beijing Municipality, China, 101149
        • Recruiting
        • Beijing Chest Hospital
        • Principal Investigator:
          • Gen Lin, M.D.
        • Contact:
          • Gen Lin, M.D.
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • The First Medical Center of Chinese PLA General Hospital
        • Contact:
          • Yi Hu, M.D.
        • Principal Investigator:
          • Yi Hu, M.D.
      • Beijing, Beijing Municipality, China, 101149
        • Recruiting
        • Beijing Luhe Hospital, Capital Medical University
        • Contact:
          • Dong Yan, M.D.
        • Principal Investigator:
          • Dong Yan, M.D.
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Ge Luo, M.D.
        • Principal Investigator:
          • Ge Luo, M.D.
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Haipeng Xu, M.D.
        • Principal Investigator:
          • Haipeng Xu, M.D.
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • PLA No. 900 Hospital of the Joint Support Force
        • Contact:
          • Zongyang Yu, M.D.
        • Principal Investigator:
          • Zongyang Yu, M.D.
      • Longyan, Fujian, China, 364000
        • Recruiting
        • Longyan First Hospital
        • Contact:
          • Chunyue Wang, M.D.
        • Principal Investigator:
          • Chunyue Wang, M.D.
      • Zhangzhou, Fujian, China, 363000
        • Recruiting
        • Zhangzhou Municipal Hospital of Fujian Province
        • Contact:
          • Li Lin, M.D.
        • Principal Investigator:
          • Li Lin, M.D.
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Shihong Wei, M.D.
        • Principal Investigator:
          • Shihong Wei, M.D.
    • Guangdong
      • Jiangmen, Guangdong, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
          • Gengsheng Yu, M.D.
        • Principal Investigator:
          • Gengsheng Yu, M.D.
    • Guangxi
      • Liuchow, Guangxi, China, 545006
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
          • Leili Wang, M.D.
        • Principal Investigator:
          • Leili Wang, M.D.
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Qing Bu, M.D.
        • Principal Investigator:
          • Qing Bu, M.D.
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Affiliated Cancer Hospital of Guangxi Medical University
        • Contact:
          • Jiangqiong Huang, M.D.
        • Principal Investigator:
          • Jiangqiong Huang, M.D.
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Jing Li, M.D.
        • Principal Investigator:
          • Jing Li, M.D.
    • Guizhou
      • Guiyang, Guizhou, China, 400042
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
          • Yu Zhang, M.D.
        • Principal Investigator:
          • Yu Zhang, M.D.
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • The Second Affiliated Hospital of Zunyi Medical University
        • Contact:
          • Shiyun Xing, M.D.
        • Principal Investigator:
          • Shiyun Xing, M.D.
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Jun Wang, M.D.
        • Contact:
          • Jun Wang, M.D.
      • Tangshan, Hebei, China, 063001
        • Recruiting
        • Tangshan People's Hospital
        • Contact:
          • Zhiwu Wang, M.D.
        • Principal Investigator:
          • Zhiwu Wang, M.D.
        • Principal Investigator:
          • Guilan Dong, M.D.
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Yan Yu, M.D.
        • Principal Investigator:
          • Yan Yu, M.D.
      • Harbin, Heilongjiang, China, 150086
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
          • Yu Yang, M.D.
        • Principal Investigator:
          • Yu Yang, M.D.
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang Cancer Hospital
        • Contact:
          • Anping Zheng, M.D.
        • Principal Investigator:
          • Anping Zheng, M.D.
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Qingqin Zhang, M.D.
        • Principal Investigator:
          • Qingqin Zhang, M.D.
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Yanqiu Zhao, M.D.
        • Contact:
          • Yanqiu Zhao, M.D.
    • Hubei
      • Jingzhou, Hubei, China, 434000
        • Recruiting
        • Jingzhou First People's Hospital
        • Contact:
          • Yonghua Yang, M.D.
        • Principal Investigator:
          • Yonghua Yang, M.D.
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Xiaorong Dong, M.D.
        • Contact:
          • Xiaorong Dong, M.D.
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Lin Wu, M.D.
        • Principal Investigator:
          • Huai Liu, M.D.
        • Contact:
          • Lin Wu, M.D.
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The First Affiliated Hospital of South China University
        • Contact:
          • Yuehua Li, M.D.
        • Principal Investigator:
          • Yuehua Li, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Lin Shi, M.D.
        • Principal Investigator:
          • Lin Shi, M.D.
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • General Hospital of the PLA Eastern Theater Command
        • Contact:
          • Xiangfeng Lv, M.D.
        • Principal Investigator:
          • Xiangfeng Lv, M.D.
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • Xuzhou Municipal Hospital
        • Contact:
          • Haitao Yin, M.D.
        • Principal Investigator:
          • Haitao Yin, M.D.
    • Jiangxi
      • Gannan, Jiangxi, China, 341000
        • Recruiting
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Jie Li, M.D.
        • Principal Investigator:
          • Jie Li, M.D.
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Longhua Sun, M.D.
        • Principal Investigator:
          • Longhua Sun, M.D.
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
          • Haifeng Liu, M.D.
        • Principal Investigator:
          • Haifeng Liu, M.D.
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Bo Jin, M.D.
        • Principal Investigator:
          • Bo Jin, M.D.
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • Ningxia Medical University General Hospital
        • Contact:
          • Yanyang Wang, M.D.
        • Principal Investigator:
          • Yanyang Wang, M.D.
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Zhe Yang, M.D.
        • Principal Investigator:
          • Zhe Yang, M.D.
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Principal Investigator:
          • Hui Zhu, M.D.
        • Contact:
          • Hui Zhu, M.D.
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jianhua Shi, M.D.
        • Principal Investigator:
          • Jianhua Shi, M.D.
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi People's Hospital
        • Contact:
          • Zhongmin Zhang, M.D.
        • Principal Investigator:
          • Zhongmin Zhang, M.D.
        • Sub-Investigator:
          • Xueliang Xu, M.D.
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Qingdao Central Hospital of Health and Rehabilitation Sciences University
        • Contact:
          • Zhen Zhang, M.D.
        • Contact:
          • Xiaotao Zhang, M.D.
        • Principal Investigator:
          • Zhen Zhang, M.D.
        • Principal Investigator:
          • Xiaotao Zhang, M.D.
      • Zaozhuang, Shandong, China, 277100
        • Recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
          • Shifeng Kan, M.D.
        • Principal Investigator:
          • Shifeng Kan, M.D.
    • Shangdong
      • Weifang, Shangdong, China, 261041
        • Recruiting
        • Weifang NO.2 People's Hospital
        • Contact:
          • Kunning Yang, M.D.
        • Principal Investigator:
          • Kunning Yang, M.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Zhengfei Zhu, M.D.
        • Principal Investigator:
          • Zhengfei Zhu, M.D.
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
          • Fengying Wu, M.D.
        • Principal Investigator:
          • Fengying Wu, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China, 300013
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Hongwei Li, M.D.
        • Principal Investigator:
          • Hongwei Li, M.D.
      • Xi’an, Shanxi, China, 710038
        • Recruiting
        • Tangdu Hospital, The Fourth Military Medical University
        • Contact:
          • Xiaolong Yan, M.D.
        • Principal Investigator:
          • Xiaolong Yan, M.D.
    • Sichuan
      • Mianyang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
          • Xiaobo Du, M.D.
        • Principal Investigator:
          • Xiaobo Du, M.D.
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Principal Investigator:
          • Dingzhi Huang, M.D.
        • Contact:
          • Dingzhi Huang, M.D.
    • Xi'an
      • Shaxi, Xi'an, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Yu Yao, M.D.
        • Contact:
          • Yu Yao, M.D.
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The first Affiliated hospital of Wenzhou medical University
        • Contact:
          • Yuping Li, M.D.
        • Principal Investigator:
          • Yuping Li, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion Criteria:

  1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
  2. Aged ≥18 years on day fo signing the informed consent.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Life expectancy ≥ 3 months
  5. Histologically or cytologically confirmed small cell lung cancer.
  6. 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.
  7. Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy.
  8. Adequate organ function.
  9. 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.

Exclusion Criteria:

  1. Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
  2. Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in inclusion/exclusion criteria, except for alopecia.
  3. Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
  4. Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
  5. History of active malignant tumors within the previous 5 years.
  6. 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.
  7. 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..
  8. Have serious neurological or mental illnesses, including dementia and epileptic seizures.
  9. Pregnant or lactating women.
  10. Have cardiovascular or cerebrovascular diseases or risk factors.
  11. 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.
  12. Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy.
  13. Prior treatments with anti-angiogenic therapy.
  14. 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.
  15. 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.
  16. 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.
  17. Known interstitial lung disease or non infectious pneumonia, which currently has symptoms or requires systemic corticosteroid treatment in the past,or investigator juges may affect the toxicity assessment or management related to the study treatment.
  18. Known severe infection within 4 weeks prior to the first dose of study drug. Known active tuberculosis. Known active syphilis infection. Known history of immunodeficiency or positive HIV test results.
  19. .Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  20. Active hepatitis B or active hepatitis C.
  21. Received a live vaccine within 30 days prior to the first dose of study drug, or planning to receive a live vaccine during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ak112 arm
AK112 intravenous [IV]),every 3 weeks
Drug: AK112
AK112 20mg/kg, intravenous [IV]),Q3W
Other Names:
  • Ivonescimab
Placebo Comparator: Placebo arm
Placebo intravenous [IV]),every 3 weeks
Other: Placebo
Placebo, intravenous [IV]),Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC)
Time Frame: 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
Approximately 6 years
Overall Survival (OS)
Time Frame: Approximately 6 years
OS is defined as the time from randomization or first dosing to death due to any cause.
Approximately 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS assessed by investigator per RECIST v1.1
Time Frame: 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
Approximately 6 years
Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
ORR assessed by investigator Per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
Disease control rate(DCR) assessed by BICR per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
DCR assessed by investigator per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
Duration of Response (DOR) assessed by BICR per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
DOR assessed by investigator per RECIST v1.1
Time Frame: Approximately 6 years
Approximately 6 years
Number of participants with adverse event (AE)
Time Frame: Approximately 6 years
The number of participants experiencing an AE and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

May 25, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 8, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK112-311

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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