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

Trial status:Recruiting
Trial ID:
BNT327-06
NCT ID:
NCT06712316
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2024-515764-31-00
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
Collaborator:
Biotheus Inc.
Recruiting

Trial Details

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.

Medical Condition
  • Lung Cancer
    • Study Drug
  • Pumitamig
    • See more
  • Pembrolizumab
  • Carboplatin
  • Pemetrexed
  • Paclitaxel
    • Phase
    Phase 2/Phase 3
    Type
    Interventional
    Estimated Enrolment
    982
    Estimated Trial Date
    Jan 2025 - Dec 2029

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria
    • Have histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 8th edition without actionable epidermal growth factor receptor mutation or anaplastic lymphoma kinase (ALK) rearrangement.
    • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
    • Eastern Cooperative Oncology Group performance status of 0 or 1.
    • Adequate organ function.
    Exclusion criteria
    • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic component.
    • Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
      • Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody or received platinum-based chemotherapy and/or anti-PD(L)-1 as part of adjuvant or neo-adjuvant treatment
      • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
    • Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
    • Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
    • Participants with evidence of major coagulation disorders or other significant risks of hemorrhage.
    • Have superior vena cava syndrome or symptoms of spinal cord compression.

      • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Trial Locations

    Location
    Status
    Location
    Alaska Oncology and Hematology, LLC
    Anchorage, Alaska, United States, 99508
    Status
    Recruiting
    Location
    Clermont Oncology Center
    Clermont, Florida, United States, 34711
    Status
    Recruiting
    Location
    H. Lee Moffit Cancer center and research institute
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    Physicians Clinic of Iowa
    Cedar Rapids, Iowa, United States, 52401-2112
    Status
    Recruiting
    Location
    Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
    Iowa City, Iowa, United States, 52242
    Status
    Recruiting
    Location
    Baptist Health
    Lexington, Kentucky, United States, 40503
    Status
    Recruiting
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