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This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum(Cisplatin or Carboplatin) plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.
The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum(Cisplatin or Carboplatin) plus etoposide in treatment naive extensive stage small cell lung cancer.
Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TORIPALIMAB | Experimental |
| |
| Chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo | Drug | TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression Free Survival) by investigator | Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1) | Approximately 2 years |
| Overall suvival (OS) | Overall suvival (OS) | Approximately 2.8 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board) | PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria; | Approximately 2 years |
| ORR (Objective Response Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ying Cheng | Changchun | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39541202 | Derived | Cheng Y, Zhang W, Wu L, Zhou C, Wang D, Xia B, Bi M, Fu X, Li C, Lv D, Zhao Y, Chen G, Yi T, Huang J, Li M, Yang R, Huang X, Wang Y, Zhang M, Pan Y, Sun Y, Hu S, Zhang X, Zhou M, Fang J, Jin F, Liu Y, Li Y, Zhang Z, Hu J, Liu L, Wang R, Li Y, Gu K, Ding C, Fan Q, Zhang G, Chen Y, Jiang L, Zheng WE, Chen S, Huang C, Han Z, Yang H, Wang J, Wang B, Wu H, Bao Y, Li M, Luo X, Gu S, Yu W, Xu K, Zhang S, Yu J. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):16-25. doi: 10.1001/jamaoncol.2024.5019. |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;
| Approximately 2 years |
| DOR (Duration of Response) | Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1; | Approximately 2 years |
| DCR (Disease of Response) | Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1; | Approximately 2 years |
| TTR (Time to Response) | Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1; | Approximately 2 years |
| OS (Overall Survival) rate | OS rates at 1 and 2 years | Approximately 2 years |
| Incidence of AEs/SAEs | Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0 | Approximately 2 years |
| PFS (Progression Free Survival) Rate | PFS rates at 6-month(inestigators and BICR) and at 1-year | Approximately 1year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |