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A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv34
  2. Study sites revised (61)v33 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 61 sitesv32
  4. Site details revised at 1 of 61 sitesv31
  5. Re-verified, no change to tracked fieldsv30
Show 28 earlier versionsHide 28 earlier versions
  1. Primary completion date: Oct 2025 to Dec 31, 2025 Completion date: Oct 2025 to Oct 2026v29 Show 1 more changeShow less
    • Completion date: Oct 2025 to Oct 2026
  2. Study sites: 62 to 61v28
  3. Study sites: 63 to 62v27
  4. Study sites: 64 to 63v26
  5. Study sites: 65 to 64v25
  6. Primary and study completion dates: Jul 2025 to Oct 2025 Eligibility criteria expanded, about 81 words · Secondary endpoints: 12 to 5 · Site details revised at 15 of 65 sitesv24 Show 3 more changesShow less
    • Eligibility criteria expanded, about 81 words
    • Secondary endpoints: 12 to 5
    • Site details revised at 15 of 65 sites

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites revised (65)v23 See this version in full on ClinicalTrials.gov ↗
  8. Trial status: Recruiting to Active, Not Recruiting Study sites: 61 to 65v22 Show 1 more changeShow less
    • Study sites: 61 to 65
  9. Study sites: 64 to 61v21
  10. Study sites revised (64)v20 See this version in full on ClinicalTrials.gov ↗
  11. Study sites revised (64)v19 See this version in full on ClinicalTrials.gov ↗
  12. Site details revised at 3 of 64 sitesv18
  13. Re-verified, no change to tracked fieldsv17
  14. Study sites: 65 to 64v16
  15. Study sites: 63 to 65v15
  16. Re-verified, no change to tracked fieldsv14
  17. Study sites: 68 to 63v13
  18. Study sites: 63 to 68v12
  19. Study sites: 59 to 63v11
  20. Enrollment target: 200 to 400 Study sites: 49 to 59 · Interventions: BGB-A445 (Drug), Carboplatin (Drug), Cisplatin (Drug), LBL-007 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Tislelizumab (Drug)… to BGB-15025 (Drug), BGB-A445 (Drug), Carboplatin (Drug), Cisplatin (Drug), LBL-007 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug)… · Eligibility criteria expanded, about 8 words · 2 morev10 Show 5 more changesShow less
    • Study sites: 49 to 59
    • Interventions: BGB-A445 (Drug), Carboplatin (Drug), Cisplatin (Drug), LBL-007 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Tislelizumab (Drug)… to BGB-15025 (Drug), BGB-A445 (Drug), Carboplatin (Drug), Cisplatin (Drug), LBL-007 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug)…
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 11 to 12
    • Study arms: 6 to 8

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 48 to 49v9
  22. Study sites: 31 to 48v8
  23. Study sites: 28 to 31v7
  24. Study sites: 22 to 28v6
  25. Study sites: 15 to 22v5
  26. Study sites: 5 to 15v4
  27. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 300 to 200 · Study sites: 0 to 5 · Primary and study completion dates: Nov 2025 to Jul 2025 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 300 to 200
    • Study sites: 0 to 5
    • Primary and study completion dates: Nov 2025 to Jul 2025
    • Start date changed from estimate of Mar 2023 to Mar 7, 2023
  28. Eligibility criteria shortened, about 20 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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 purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).
Trial Details
NCT Number NCT05635708
Lead Sponsor BeiGene
Conditions Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov