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This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 +chemotherapy | Experimental | subject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles |
|
| chemotherapy | Active Comparator | carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first. | up to 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1 | up to 24 month |
| Overall Survival (OS) | defined as time from the randomized to the time of the patient's death from any reason assessed by researchers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianjun Zou, MD, PhD | Jiangsu HengRui Medicine Co., Ltd. | Study Director |
| Caicun Zhou, MD, PhD | Tongji University, Shanghai Pulmonary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230036 | China | ||
| The Second Affiliated Hospital Of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34980131 | Derived | Jiang T, Chen J, Xu X, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Zhang Y, Zhang J, Yang Z, Shi W, Zou J, Zhou C, Ren S. On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial. Mol Cancer. 2022 Jan 3;21(1):4. doi: 10.1186/s12943-021-01479-4. | |
| 34923163 |
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| The placebo | Drug | in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip. |
|
| up to 24 month |
| Objective Response Rate (ORR) | The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1. | up to 24 month |
| disease control rate (DCR) | The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1. | up to 24 month |
| Duration of response (DoR) | According to Recist v 1.1 accessed by investigators | up to 24 month |
| Adverse events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03 | up to 24 month |
| Hefei |
| Anhui |
| 230036 |
| China |
| Anhui Chest Hospital | Hefei | Anhui | MD | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China |
| The Fifth Medical Center of PLA Ceneral Hospital | Beijing | Beijing Municipality | 100000 | China |
| The Seventh Medical Center of PLA Ceneral Hospital | Beijing | Beijing Municipality | 100000 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| 900TH Hospital of Joint Logistics Support Force | Fuzhou | Fujian | 350001 | China |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | Guangdong | 510095 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Jieyang People's Hospital | Jieyang | Guangdong | 522000 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563003 | China |
| Affiliated Hospital of Chengde Medical College | Chengde | Hebei | 067000 | China |
| The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital) | Shijiazhuang | Hebei | 50000 | China |
| Tangshan People's Hospital | Tangshan | Hebei | 63001 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430000 | China |
| Tongji Hospital, Tongji Medical College of Hust | Wuhan | Hubei | 430000 | China |
| Xiang yang Central Hospital | Xiangyang | Hubei | 441000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | Hunan | 410008 | China |
| The Third Xiangya Hospital Of Central South University | Changsha | Hunan | 410013 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | 214122 | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | 330006 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130012 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130012 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| LinYi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Shanghai Pulmonary Hospital, Tongji University | Shanghai | Shanghai Municipality | 200433 | China |
| Baoji Central Hospital | Baoji | Shanxi | 721000 | China |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | 046000 | China |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 030000 | China |
| Shaanxi Provincial Cancer Hospital | Xian | Shanxi | 710061 | China |
| Sichuan Provincial Cancer Hospital | Chengdu | Sichuan | 610000 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center | Kunming | Yunnan | 650118 | China |
| The First Affiliated Hospital,ZheJiang University | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital ZheJiang University School Of Medicine | Hangzhou | Zhejiang | 310018 | China |
| ZheJiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The Second Affiliated Hospital of Zhejiang University of Medicine | Hangzhou | Zhejiang | 310052 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317000 | China |
| Derived |
| Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. doi: 10.1016/j.jtho.2021.11.018. Epub 2021 Dec 16. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| 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 |
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