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Small Cell Lung Cancer

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Carboplatin

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TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo

Ying Cheng, prof

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).

Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

A Phase III Randomized, Double-Blind, Placebo-controlled Study of Platinum(Cisplatin or Carboplatin) Plus Etoposide With or Without Toripalimab as First Line Therapy in Patients With ExtensiveStage Small Cell Lung Cancer

Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0

PFS rates at 6-month（inestigators and BICR） and at 1-year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer	NCT04012606	Small Cell Lung...	TORIPALIMAB INJ...	18 Years -	Shanghai Junshi Bioscience Co., Ltd.
Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer	NCT04012606	Small Cell Lung...	TORIPALIMAB INJ...	18 Years -	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for toripalimab injection(js001 ) carboplatin cisplatin etoposide placebo