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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ak112 arm | Experimental | AK112 intravenous [IV]),every 3 weeks |
|
| Placebo arm | Placebo Comparator | Placebo intravenous [IV]),every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | AK112 20mg/kg, intravenous [IV]),Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigator per RECIST v1.1 | 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 |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifang Yao, M.D. | Contact | +86-0760-89873999 | clinicaltrials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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Parallel assignment
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| Placebo | Other | Placebo, intravenous [IV]),Q3W |
|
| 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 |
| Duration of Response (DOR) assessed by BICR per RECIST v1.1 | Approximately 6 years |
| DOR assessed by investigator per RECIST v1.1 | Approximately 6 years |
| Number of participants with adverse event (AE) | 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 |
| The First Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| Beijing Chest Hospital | Recruiting | Beijing | Beijing Municipality | 101149 | China |
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| Beijing Luhe Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101149 | China |
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| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijin | Beijin | 100021 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
|
| PLA No. 900 Hospital of the Joint Support Force | Recruiting | Fuzhou | Fujian | 350025 | China |
|
| Longyan First Hospital | Recruiting | Longyan | Fujian | 364000 | China |
|
| Zhangzhou Municipal Hospital of Fujian Province | Recruiting | Zhangzhou | Fujian | 363000 | China |
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| Gansu Provincial Cancer Hospital | Recruiting | Lanzhou | Gansu | 730050 | China |
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| Jiangmen Central Hospital | Recruiting | Jiangmen | Guangdong | 529030 | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | Guangxi | 545006 | China |
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| Affiliated Cancer Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangzhou | 510080 | China |
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| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | 400042 | China |
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| The Second Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Tangshan People's Hospital | Recruiting | Tangshan | Hebei | 063001 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150086 | China |
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| Anyang Cancer Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453100 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Jingzhou First People's Hospital | Recruiting | Jingzhou | Hubei | 434000 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| The First Affiliated Hospital of South China University | Recruiting | Hengyang | Hunan | 421001 | China |
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| General Hospital of the PLA Eastern Theater Command | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Xuzhou Municipal Hospital | Recruiting | Xuzhou | Jiangsu | 221002 | China |
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| The First Affiliated Hospital of Gannan Medical University | Recruiting | Gannan | Jiangxi | 341000 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | 130000 | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Ningxia Medical University General Hospital | Recruiting | Yinchuan | Ningxia | 750004 | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | 276000 | China |
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| Linyi People's Hospital | Recruiting | Linyi | Shandong | 276000 | China |
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| Qingdao Central Hospital of Health and Rehabilitation Sciences University | Recruiting | Qingdao | Shandong | 266000 | China |
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| Zaozhuang Municipal Hospital | Recruiting | Zaozhuang | Shandong | 277100 | China |
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| Weifang No.2 People's Hospital | Recruiting | Weifang | Shangdong | 261041 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | 300013 | China |
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| Tangdu Hospital, The Fourth Military Medical University | Recruiting | Xi’an | Shanxi | 710038 | China |
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| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Shaxi | Xi'an | 710061 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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