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.
Non Small Cell Lung Cancer
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.
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
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XCancer/Dothan Hematology & Oncology - 1114, Dothan, Alabama, United States, 36303
Genesis Cancer and Blood Institute - 1123, Russellville, Arkansas, United States, 72801
The Oncology Institute (TOI) Clinical Research - 1109, Cerritos, California, United States, 90703
Emad Ibrahim MD Inc. - 1147, Redlands, California, United States, 92373
UC Davis Comprehensive Cancer Center - 1103, Sacramento, California, United States, 95817
Bass Medical Group - 1155, Walnut Creek, California, United States, 94598
Nuvance Health - 1118, Norwalk, Connecticut, United States, 06850
D&H Cancer Research Center LLC - 1153, Margate, Florida, United States, 33063
Ocala Oncology Center PL - 1102, Ocala, Florida, United States, 34474
AdventHealth Cancer Institute - 1105, Orlando, Florida, United States, 32804
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
OncoC4, Inc.,
Mark Socinski, MD, PRINCIPAL_INVESTIGATOR, Advent Health System
Tianhong Li, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis
Kai He, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University
2027-06-30