NCT04379635

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	administered via Intravenous (IV) injection
DRUG	Cisplatin injection	administered via IV infusion
DRUG	Paclitaxel injection	administered via IV infusion
DRUG	Pemetrexed Disodium	administered via IV infusion
DRUG	Placebos	Placebo to match tislelizumab IV infusion
DRUG	Carboplatin	administered via IV infusion

Timeline

• Start date: 2020-05-29
• Primary completion: 2023-08-21
• Completion: 2027-03-31
• First posted: 2020-05-07
• Last updated: 2026-03-18

Locations

44 sites across 1 country: China