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Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 30 sitesv13
  2. Primary endpoints revised (4) Study sites: 23 to 30 · Eligibility criteria expanded, about 63 words · Secondary endpoints revised (8) · 3 morev12 Show 6 more changesShow less
    • Study sites: 23 to 30
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 51 words
    • Collaborators expanded, about 5 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 15 to 23v11
  4. Study sites: 12 to 15v10
  5. Primary endpoints revised (4) Study sites: 10 to 12 · Interventions: BNT327 (Drug), Docetaxel (Drug) to Docetaxel (Drug), Pumitamig (Drug) · Secondary endpoints revised (8) · 1 morev9 Show 4 more changesShow less
    • Study sites: 10 to 12
    • Interventions: BNT327 (Drug), Docetaxel (Drug) to Docetaxel (Drug), Pumitamig (Drug)
    • Secondary endpoints revised (8)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 8 to 10v8
  2. Study sites: 7 to 8v7
  3. Study sites: 5 to 7v6
  4. Study sites: 4 to 5v5
  5. Site details revised at 1 of 4 sitesv4
  6. Study sites: 1 to 4v3
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 2025 to Mar 3, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2025 to Mar 3, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
Trial Details
NCT Number NCT06841055
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov