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This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC148 Plus Platinum-Based Chemotherapy | Experimental |
| |
| Tislelizumab Plus Platinum-Based Chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC148 plus Carboplatin and Paclitaxel | Drug | RC148, Carboplatin, Paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is assessed in accordance with RECIST v1.1 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS | 24 months |
| PFS (assessed by the investigator(s)) | PFS assessed by the investigator(s) is assessed in accordance with RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongfeng Yang | Contact | 010-65384976 | yongfeng.yang@remegen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China | ||
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| Tislelizumab plus Carboplatin and Paclitaxel | Drug | Tislelizumab, Carboplatin, Paclitaxel |
|
|
| 24 months |
| Objective Response Rate (ORR) | ORR is assessed in accordance with RECIST v1.1 | 24 months |
| Duration of Response (DoR) | DoR is assessed in accordance with RECIST v1.1 | 24 months |
| Time to Response (TTR) | TTR is assessed in accordance with RECIST v1.1 | 24 months |
| Treatment-Emergent Adverse Event (TEAE) | Adverse events during treatment | 46 months |
| Peking University Cancer Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Cancer Hospital Affiliated to Chongqing University | Recruiting | Chongqing | Chongqing Municipality | China |
| Chongqing Medical University First Affiliated Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
| Union Hospital Affiliated to Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
| Gansu Cancer Hospital | Recruiting | Lanzhou | Gansu | China |
| The First Affiliated Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | China |
| Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | China |
| Cancer Hospital Affiliated to Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
| Sun Yat-sen University First Affiliated Hospital | Recruiting | Guangzhou | Guangdong | China |
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
| Jiangmen Central Hospital | Recruiting | Jiangmen | Guangdong | China |
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | China |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | China |
| The Second Affiliated Hospital of Guilin Medical University | Recruiting | Guilin | Guangxi | China |
| Cancer Hospital Affiliated to Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangzhou | China |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | China |
| The Fourth Affiliated Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| Cancer Hospital Affiliated to Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
| Anyang Cancer Hospital | Recruiting | Anyang | Henan | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | China |
| Nanyang Second People's Hospital | Recruiting | Nanyang | Henan | China |
| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | China |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | China |
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | China |
| Zhongda Hospital Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
| Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | China |
| Liaoning Cancer Hospital | Recruiting | Shenyang | Liaoning | China |
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | China |
| The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army | Recruiting | Xi'an | Shaanxi | China |
| Affiliated Hospital of Binzhou Medical University | Recruiting | Binzhou | Shandong | China |
| Jinan Central Hospital | Recruiting | Jinan | Shandong | China |
| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | China |
| Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | China |
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| Tianjin Chest Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| Affiliated Cancer Hospital of Xinjiang University | Recruiting | Ürümqi | Xinjiang | China |
| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | China |
| Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 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 |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D017671 | Platinum Compounds |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D007287 | Inorganic Chemicals |
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