OncRef

Clinical Trial: NCT04005716

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:BeiGene
Information Provided By:BeiGene
Last Update Posted:2025-02-28

Study Overview

Brief 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).

Official Title

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

Conditions

Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Tislelizumab
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Placebo

Other Study ID Numbers

  • BGB-A317-312
  • CTR20190511

Start Date (Actual)

2019-07-22

Primary Completion Date (Actual)

2023-04-19

Study Completion Date (Actual)

2023-12-29

Enrollment (Actual)

457

Study Type

Interventional

Phase

Phase 3