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Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 221 → 225 locationsv14
  2. Trial sites expanded: 211 → 221 locationsv13
  3. Trial sites expanded: 202 → 211 locationsv12
  4. Trial sites expanded: 138 → 202 locationsv11
  5. Study sites: 107 to 138v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 72 to 107v9
  2. Study sites: 64 to 72v8
  3. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Apr 2028 to Dec 2028 · Enrollment target: 439 to 621 · Study sites: 57 to 64 · 8 morev7 Show 11 more changesShow less
    • Primary completion date: Apr 2028 to Dec 2028
    • Enrollment target: 439 to 621
    • Study sites: 57 to 64
    • Completion date: Sep 2028 to Mar 2029
    • Interventions: Atezolizumab (Drug), BNT327 (Drug), Carboplatin (Drug), Etoposide (Drug) to Atezolizumab (Drug), Carboplatin (or cisplatin if carboplatin is not tolerated) (Drug), Etoposide (Drug), Pumitamig (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints revised (13)
    • Study description expanded, about 48 words
    • Collaborator revised
    • Study title revised
    • Study arms: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 57 of 57 sitesv6 Show 1 more changeShow less
    • Site details revised at 57 of 57 sites
  5. Study sites: 9 to 57v5
  6. Study sites: 5 to 9 Eligibility criteria expanded, about 12 words · Secondary endpoints revised (13) · Study description revisedv4 Show 3 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (13)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 3 to 5 Start date changed from estimate of Jan 2025 to Feb 3, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Jan 2025 to Feb 3, 2025
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date: Dec 2024 to Jan 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date: Dec 2024 to Jan 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
Trial Details
NCT Number NCT06712355
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Extensive-stage Small-cell Lung Cancer
Enrollment 621 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov