ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Trial status:Recruiting
Trial ID:
PRESERVE-003
NCT ID:
NCT05671510
EudraCT ID:
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.
OncoC4, Inc.
Recruiting

Trial Details

The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Medical Condition
  • Lung Cancer
    • Trial Drug
  • Gotistobart
    • See more
  • Docetaxel
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    600
    Estimated Trial Date
    Jun 2023 - Jun 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    XCancer/Dothan Hematology & Oncology - 1114
    Dothan, Alabama, United States, 36303
    Status
    Recruiting
    Location
    Genesis Cancer and Blood Institute - 1123
    Russellville, Arkansas, United States, 72801
    Status
    Recruiting
    Location
    The Oncology Institute (TOI) Clinical Research - 1109
    Cerritos, California, United States, 90703
    Status
    Recruiting
    Location
    Emad Ibrahim MD Inc. - 1147
    Redlands, California, United States, 92373
    Status
    Recruiting
    Location
    UC Davis Comprehensive Cancer Center - 1103
    Sacramento, California, United States, 95817
    Status
    Recruiting
    Location
    Bass Medical Group - 1155
    Walnut Creek, California, United States, 94598
    Status
    Recruiting