Study Name: PRESERVE-003

Recruiting

Lung

PRESERVE-003, A PHASE 3, TWO-STAGE, RANDOMIZED STUDY OF ONC-392 VERSUS DOCETAXEL IN METASTATIC NON-SMALL CELL LUNG CANCER THAT PROGRESSED ON PD-1/PD-L1 INHIBITORS

NCT#05671510

clinicaltrials.gov/show/NCT05671510

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.

Male and Female – 18 years and older

• Metastatic Non-Small Cell Lung Cancer; Metastasis can be regional lymph nodes or distant
• Disease progression after treatment with the most recent line of treatment being either:
• At least 12 weeks of standard doses of PD-1/PD-L1 inhibitor in combination with platinum-containing doublet chemotherapy, or
• Prior treatment with at least 2 cycles of platinum-containing doublet chemotherapy, followed by at least 12 weeks of standard doses of PD-1/PD-L1 inhibitor-based immunotherapy
• Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD- L1 inhibitors are allowed

• Pts who have documented targetable mutations or genomic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK, or HER2. Patients with mutation or genomic alterations in KRAS are not excluded