NCT04012606

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo	TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

Timeline

• Start date: 2019-07-23
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2019-07-09
• Last updated: 2025-01-16

Locations

1 site across 1 country: China