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

NCT04379635 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2026-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2023-08-21
Completion
2027-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04379635 on ClinicalTrials.gov