drugset / Trial / NCT04012606

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

NCT04012606

Phase 3 Completed 442 enrolled Shanghai Junshi Bioscience Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

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).

Timeline

Start
2019-07-23
Primary completion
2023-04-20
Completion
2023-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified
Background Etoposide Small molecule