Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy

Trial status:Recruiting
Trial ID:
BNT327-07
NCT ID:
NCT06841055
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2024-518279-80-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy.

Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially.

Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel.

Medical Condition
  • Lung Cancer
    • Trial Drug
  • BNT327
    • See more
  • Docetaxel
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    60
    Estimated Trial Date
    Mar 2025 - Oct 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Baptist Health Hardin
    Elizabethtown, Kentucky, United States, 42701
    Status
    Recruiting
    Location
    NYU Langone - NYU Grossman School of Medicine
    New York, New York, United States, 10016
    Status
    Recruiting
    Location
    Millennium Research and Clinical Development, LLC
    Houston, Texas, United States, 77090
    Status
    Active, not recruiting
    Location
    Gyeongsang National University Hospital (GNUH)
    Jinju-si, Gyeongsangnam-do, Republic of Korea, 52727
    Status
    Recruiting
    Location
    Gachon University Gil Medical Center
    Incheon, Republic of Korea, 21565
    Status
    Recruiting
    Location
    Velindre NHS Trust, Velindre Cancer Centre
    Cardiff, United Kingdom, CF14 2TL
    Status
    Recruiting
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