NCT03711305

Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Randomized, Double-blinded, Placebo Controlled, Multicenter, Phase III Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.

Detailed description

Participants will be randomized in a 1:1 ratio to receive either SHR-1316 + carboplatin + etoposide or placebo + carboplatin + etoposide for 4-6 cycles in the induction phase followed by maintenance with SHR-1316 or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or or unacceptable toxicity.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SHR-1316	SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
DRUG	Carboplatin	Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUG	Etoposide	Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUG	Placebo	Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

Timeline

• Start date: 2018-12-30
• Primary completion: 2022-10-01
• Completion: 2023-12-01
• First posted: 2018-10-18
• Last updated: 2022-04-18

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study