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Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 5 changed
See other at-risk trials from BioNTech SE

Record History

  1. Trial sites expanded: 262 → 365 locations Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 8 of 18 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 8 of 18 entries
  2. Study sites: 261 to 262v18
  3. Primary endpoint(s) modified Enrollment increased: 1260 → 1580 participants · Primary completion moved earlier from Feb 2029 to Jan 2029 · Completion pushed from Mar 2030 to Dec 2031 · 5 morev17 Show 8 more changesShow less
    • Enrollment increased: 1260 → 1580 participants
    • Primary completion moved earlier from Feb 2029 to Jan 2029
    • Completion pushed from Mar 2030 to Dec 2031
    • Trial arms changed: 8 → 10
    • Secondary endpoints revised (18)
    • Study description expanded, about 68 words
    • Site details revised at 1 of 261 sites
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial sites expanded: 225 → 261 locationsv16
  5. Trial sites expanded: 206 → 225 locationsv15
  6. Trial sites expanded: 184 → 206 locationsv14
  7. Study sites: 172 to 184v13
  8. Study sites: 120 to 172v12
  9. Primary endpoints: 6 to 5 Enrollment target: 982 to 1260 · Study sites: 110 to 120 · Primary completion date: Dec 2029 to Feb 2029 · 6 morev11 Show 9 more changesShow less
    • Enrollment target: 982 to 1260
    • Study sites: 110 to 120
    • Primary completion date: Dec 2029 to Feb 2029
    • Completion date: Dec 2030 to Mar 2030
    • Secondary endpoints: 17 to 18
    • Study description shortened, about 55 words
    • Collaborator revised
    • Study title revised
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 99 to 110 Interventions: BNT327 (Drug), Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug) to Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Pumitamig (Drug) · Eligibility criteria revised · Study description expanded, about 1 wordv10 Show 3 more changesShow less
    • Interventions: BNT327 (Drug), Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug) to Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Pumitamig (Drug)
    • Eligibility criteria revised
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 81 to 99v9
  12. Study sites: 65 to 81v8
  13. Primary endpoints revised (6) Study sites: 47 to 65 · Secondary endpoints: 15 to 17 · Study description shortened, about 6 words · 1 morev7 Show 4 more changesShow less
    • Study sites: 47 to 65
    • Secondary endpoints: 15 to 17
    • Study description shortened, about 6 words
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 27 to 47v6
  15. Study sites: 8 to 27v5
  16. Study sites: 4 to 8v4
  17. Study sites: 2 to 4v3
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Dec 2024 to Jan 7, 2025 · Study title shortened, about 14 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 2024 to Jan 7, 2025
    • Study title shortened, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  19. 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.
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Trial Details
NCT Number NCT06712316
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Non-small Cell Lung Cancer
Enrollment 1,580 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov