A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non‑small Cell Lung Cancer (NSCLC) (ROSETTA Lung‑201)

Trial status:Will Be Recruiting
Trial ID:
CA266-0001
NCT ID:
NCT07361497
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
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.
Bristol-Myers Squibb
Collaborator:
BioNTech SE
Will Be Recruiting

Trial Details

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Medical Condition
  • Lung Cancer
    • Study Drug
  • Pumitamig
    • See more
  • Durvalumab
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    850
    Estimated Trial Date
    Apr 2026 - Sep 2030

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria

    • Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
    • Participants must have received at least 2 cycles of platinum-based concurrent chemotherapy (a total dose of radiation of at least 54 Gy).
    • Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
    • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

      • Exclusion Criteria

    • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
    • Participants must not have an active autoimmune disease.
    • Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
    • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
    • Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
    • Other protocol-defined Inclusion/Exclusion criteria apply.

    Trial Locations

    Location
    Status
    Location
    Local Institution - 0898
    Mobile, Alabama, United States, 36607
    Status
    Location
    Local Institution - 0585
    Golden, Colorado, United States, 80401
    Status
    Location
    Local Institution - 0896
    Newark, Delaware, United States, 19713
    Status
    Location
    Local Institution - 0614
    Jacksonville, Florida, United States, 32216
    Status
    Location
    Local Institution - 0711
    Ocala, Florida, United States, 34474
    Status
    Location
    Local Institution - 0429
    Tampa, Florida, United States, 33612
    Status
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