NCT04005716

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg administered intravenously on Day 1 of each 21-day cycle
DRUG	Cisplatin	75 mg/m² was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of two hours. Treatment with cisplatin was discontinued starting in Cycle 5 and beyond.
DRUG	Carboplatin	An area under the curve (AUC) of 5 mg/mL/min was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of 15 to 60 minutes. Treatment with carboplatin was discontinued starting in Cycle 5 and beyond.
DRUG	Etoposide	100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond.
DRUG	Placebo	200 mg was administered intravenously on Day 1 of each 21-day cycle to match tislelizumab.

Timeline

• Start date: 2019-07-22
• Primary completion: 2023-04-19
• Completion: 2023-12-29
• First posted: 2019-07-02
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

50 sites across 1 country: China