OncRef

Clinical Trial: NCT04379635

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:BeiGene
Information Provided By:BeOne Medicines
Last Update Posted:2026-03-18

Study Overview

Brief Summary

The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Tislelizumab
  • Drug: Cisplatin injection
  • Drug: Paclitaxel injection
  • Drug: Pemetrexed Disodium
  • Drug: Placebos
  • Drug: Carboplatin

Other Study ID Numbers

  • BGB-A317-315
  • CTR20200821

Start Date (Actual)

2020-05-29

Primary Completion Date (Actual)

2023-08-21

Study Completion Date (Estimated)

2027-03-31

Enrollment (Actual)

453

Study Type

Interventional

Phase

Phase 3