Study of Gotistobart (ONC-392/BNT316) vs. Docetaxel in PD-1 Resistant Non-small Cell Lung Cancer (PRESERVE-003)

Phase 3, Two-stage, Randomized Study of Gotistobart (ONC-392/BNT316) Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

  • Clinical Trial Information

    Trial Contact: Casillas, Bridey L; Ribacchi, Stephanie; Durand, Jennifer

  • IRB No: 20230079

    Protocol Abbrev: PRESERVE-003

    Principal Investigator: Tirrell Tremayne Johnson, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: PRESERVE-003 ID: NCT05671510

  • Objective

    The goal of this Phase 3 clinical trial is studying 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.

  • Key Eligibility

    Inclusion Criteria (Major criteria):
    1. Adult (≥ 18 years), all genders, capable of signing informed consent.
    2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.
    3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
    a. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy.
    b. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.
    Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.
    4. At least one measurable tumor lesion according to RECIST 1.1.
    5. ECOG score of 0 or 1.
    6. Adequate organ functions. Serum LDH level ≤ 2xULN.
    7. Life expectancy ≥ 3 months.