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Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

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

Record History

  1. Completion moved earlier from May 2028 to Feb 2028v19
  2. 7 versions Re-verified since Aug 12, 2025, no change to tracked fieldsv12-v18
  3. Study sites: 65 to 64v11
  4. Re-verified, no change to tracked fieldsv10
  5. Primary completion date: Mar 2025 to Jun 2027 Completion date: Aug 2026 to May 2028v9 Show 1 more changeShow less
    • Completion date: Aug 2026 to May 2028
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 67 to 65v8 Show 1 more changeShow less
    • Study sites: 67 to 65
  2. Study sites: 42 to 67v7
  3. Study sites: 30 to 42 Primary completion date: Jan 2025 to Mar 2025 · Interventions: Alkylating agent (Drug), BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 2 (DL2) (Drug), Taxane (Drug), Topoisomerase Inhibitor A… to BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 2 (DL2) (Drug), Carboplatin (Drug), Etoposide (Drug), Paclitaxel (Drug), Topotecan… · Eligibility criteria expanded, about 118 words · 2 morev6 Show 5 more changesShow less
    • Primary completion date: Jan 2025 to Mar 2025
    • Interventions: Alkylating agent (Drug), BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 2 (DL2) (Drug), Taxane (Drug), Topoisomerase Inhibitor A… to BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 2 (DL2) (Drug), Carboplatin (Drug), Etoposide (Drug), Paclitaxel (Drug), Topotecan…
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 105 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 17 to 30v5
  5. Study sites: 13 to 17v4
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 13 · Start date changed from estimate of Aug 2024 to Aug 5, 2024v3 Show 2 more changesShow less
    • Study sites: 3 to 13
    • Start date changed from estimate of Aug 2024 to Aug 5, 2024
  7. Start date: Jun 2024 to Aug 2024 Study sites: 0 to 3 · Primary completion date: Feb 2025 to Jan 2025 · Completion date: Apr 2026 to Aug 2026v2 Show 3 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Feb 2025 to Jan 2025
    • Completion date: Apr 2026 to Aug 2026
  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 II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.
Trial Details
NCT Number NCT06449209
Lead Sponsor BioNTech SE
Conditions Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov