A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
NCT ID: NCT07010263
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-05-29
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ak112 arm
AK112 intravenous \[IV\]),every 3 weeks
AK112
AK112 20mg/kg, intravenous \[IV\]),Q3W
Placebo arm
Placebo intravenous \[IV\]),every 3 weeks
Placebo
Placebo, intravenous \[IV\]),Q3W
Interventions
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AK112
AK112 20mg/kg, intravenous \[IV\]),Q3W
Placebo
Placebo, intravenous \[IV\]),Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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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
Fujian Cancer Hospital
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 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
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
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, 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
Ningxia Medical University General Hospital
Yinchuan, Ningxia, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, 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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Sichuan People's Hospital
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Qujing First People's Hospital
Qujing, Yunnan, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Rong Yu, M.D.
Role: primary
Yi Hu, M.D.
Role: primary
Gen Lin, M.D.
Role: primary
Haipeng Xu, M.D.
Role: primary
Chunyue Wang, M.D.
Role: primary
Li Lin, M.D.
Role: primary
Gengsheng Yu, M.D.
Role: primary
Leili Wang, M.D.
Role: primary
Jiangqiong Huang, M.D.
Role: primary
Qing Bu, M.D.
Role: primary
Shiyun Xing, M.D.
Role: primary
Jun Wang, M.D.
Role: primary
Zhiwu Wang, M.D.
Role: primary
Yan Yu, M.D.
Role: primary
Yu Yang, M.D.
Role: primary
Anping Zheng, M.D.
Role: primary
Qingqin Zhang, M.D.
Role: primary
Yanqiu Zhao, M.D.
Role: primary
Yonghua Yang, M.D.
Role: primary
Yongzhong Luo, M.D.
Role: primary
Lin Wu, M.D.
Role: primary
Haitao Yin, M.D.
Role: primary
Jie Li, M.D.
Role: primary
Longhua Sun, M.D.
Role: primary
Ying Cheng, M.D.
Role: primary
Yanyang Wang, M.D.
Role: primary
Zhe Yang, M.D.
Role: primary
Hui Zhu, M.D.
Role: primary
Zhongmin Zhang, M.D.
Role: primary
Zhen Zhang, M.D.
Role: primary
Xiaotao Zhang, M.D.
Role: backup
Shifeng Kan, M.D.
Role: primary
Xuwei Cai, M.D.
Role: primary
Fengying Wu, M.D.
Role: primary
Hongwei Li, M.D.
Role: primary
Haitao Lan, M.D.
Role: primary
Xiaobo Du, M.D.
Role: primary
Dingzhi Huang, M.D.
Role: primary
Gaofeng Li, M.D.
Role: primary
Runxiang Yang, M.D.
Role: primary
Chao Zhang, M.D.
Role: primary
Dongqing Lv, M.D.
Role: primary
Yuping Li, M.D.
Role: primary
Other Identifiers
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AK112-311
Identifier Type: -
Identifier Source: org_study_id
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