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The study is being conducted to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate vs. pembrolizumab in treatment naïve subjects with programmed death-ligand 1(PD-L1)-positive recurrent or metastatic non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab + famitinib | Experimental |
| |
| pembrolizumab | Experimental |
| |
| camrelizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab + famitinib | Drug | Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by BIRC | Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of RECIST v1.1 or death from any cause, whichever occurs first. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigator | Progression-Free-Survival | up to 3 years |
| ORR | Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| weixia Li, M.M | Contact | +86-15005136260 | Weixia.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | Anhui | 233000 | China |
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Camrelizumab Combined with Famitinib Malate versus Pembrolizumab
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| pembrolizumab | Drug | pembrolizumab 200 mg. |
|
| camrelizumab | Drug | Camrelizumab for injection, 200 mg. |
|
| up to 3 years |
| DCR | Disease Control Rate, determined using RECIST v1.1 criteria | up to 3 years |
| DoR | Duration of Response, determined using RECIST v1.1 criteria | up to 3 years |
| TTF | Time to Treatment Failure, defined as the time from randomization to treatment discontinuation. | up to 3 years |
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 90 days for the last SHR-1210 dose |
| OS | OS is the time interval from the date of randomization to death due to any reason or lost of follow-up | up to 4 years |
| Anhui Chest Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| The First Affiliated Hospital Of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| Beijing Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Beijing Chest Hospital,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ChongQing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361000 | China |
|
| The Second Affiliated Hospital of Xiamen Medical College | Recruiting | Xiamen | Fujian | 361000 | China |
|
| The People's Hospital of Gaozhou | Not yet recruiting | Gaozhou | Guangdong | 525200 | China |
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| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| Meizhou People's Hospital (Huangtang Hospital) | Not yet recruiting | Meizhou | Guangdong | 514000 | China |
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| Shantou Central Hospital | Not yet recruiting | Shantou | Guangdong | 515000 | China |
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| Affiliated Hospital of Guangdong Medical University | Not yet recruiting | Zhanjiang | Guangdong | 524000 | China |
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| Affiliated Hospital of Guilin Medical University | Not yet recruiting | Guilin | Guangxi | 541000 | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Not yet recruiting | Nanning | Guangxi | 530000 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530000 | China |
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| Affiliated Hospital of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | 563000 | China |
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| Hainan General Hospital | Not yet recruiting | Haikou | Hainan | 570100 | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| North China University Of Science And Technology Affiliated Hospital | Not yet recruiting | Tangshan | Hebei | 063000 | China |
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| Xingtai People's Hospital | Not yet recruiting | Xingtai | Hebei | 054000 | China |
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| Haerbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| Anyang Cancer Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| The First Affiliated Hosptial of Henan University of Science & Technology | Recruiting | Luoyang | Henan | 471000 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Shiyan Taihe Hospital | Not yet recruiting | Shiyan | Hubei | 442000 | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441000 | China |
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| Army Medical Center of PLA | Recruiting | Changsha | Hunan | 410000 | China |
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| Hunan Cancer Hospital-Thoracic Medicine Department I | Recruiting | Changsha | Hunan | 410000 | China |
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| Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ | Recruiting | Changsha | Hunan | 410000 | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| Shaoyang Central Hospital | Recruiting | Shaoyang | Hunan | 422000 | China |
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| Zhuzhou Central Hospital | Not yet recruiting | Zhuzhou | Hunan | 412000 | China |
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| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nantong Tumor Hospital | Not yet recruiting | Nantong | Jiangsu | 226000 | China |
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| Affiliated Hospital of JiangNan University | Recruiting | Wuxi | Jiangsu | 214000 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225000 | China |
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| First Affiliated Hospital of Gannan Medical University | Not yet recruiting | Ganzhou | Jiangxi | 341000 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| Liaoning Cancer Hospital | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| Shengjing Hospital Affiliated to China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| Chifeng City Hospital | Not yet recruiting | Chifeng | Neimenggu | 024000 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Neimenggu | 010000 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Shandong Cancer Hospital&Institute | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| The Affiliated of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266000 | China |
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| LinYi Cancer Hospital | Not yet recruiting | Linyi | Shangdong | 276000 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Baoji Central Hospital | Not yet recruiting | Baoji | Shanxi | 721000 | China |
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| Changzhi People's Hospital | Not yet recruiting | Changzhi | Shanxi | 046000 | China |
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| General Hospital of TISCO | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| The Second Affiliated Hospital of Air Force Military University Tangdu Hospital | Recruiting | Xi’an | Shanxi | 710000 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| Mianyang Central Hospital | Not yet recruiting | Mianyang | Sichuan | 621000 | China |
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| Yibin Second People's Hospital | Not yet recruiting | Yibin | Sichuan | 644000 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650000 | China |
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| Hangzhou Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ZheJiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
| C582435 | pembrolizumab |
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