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

StatusActive, Not Recruiting
PhasePhase 3
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (44)v13 See this version in full on ClinicalTrials.gov ↗
  2. Completion date: Oct 31, 2025 to Mar 31, 2027v12
  3. Primary completion date changed from estimate of Jun 2025 to Aug 21, 2023 Completion date: Nov 2025 to Oct 31, 2025v11 Show 1 more changeShow less
    • Completion date: Nov 2025 to Oct 31, 2025
  4. Study sites: 48 to 44v10
  5. 2 versions Re-verified since Jan 22, 2024, no change to tracked fieldsv8-v9
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Feb 2023 to Jun 2025v7
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 450 to confirmed 453 · Site details revised at 48 of 48 sitesv6 Show 2 more changesShow less
    • Enrollment target: estimated 450 to confirmed 453
    • Site details revised at 48 of 48 sites
  3. Enrollment target: 380 to 450 Site details revised at 1 of 48 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 48 sites
  4. Study sites: 42 to 48v4
  5. Study sites: 41 to 42v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 18 to 41 · Start date changed from estimate of May 2020 to May 29, 2020v2 Show 2 more changesShow less
    • Study sites: 18 to 41
    • Start date changed from estimate of May 2020 to May 29, 2020
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04379635
Lead Sponsor BeiGene
Conditions Non Small Cell Lung Cancer
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov