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Study identifier: NCT05671510 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non Small Cell Lung Cancer  ·  Sponsor: OncoC4, Inc.

PhasePhase 3
Planned participants630
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this Phase 3 clinical trial is to 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.

This description comes directly from the study's public registry record.

Talk to the study team

Pan Zheng, MD, PhD  ·  2027516823  ·  pzheng@oncoc4.com

Always discuss trial participation with your own doctor first.

Locations (152)

XCancer/Dothan Hematology & Oncology - 1114Dothan, Alabama, United StatesRecruiting
Genesis Cancer and Blood Institute - 1123Russellville, Arkansas, United StatesRecruiting
The Oncology Institute (TOI) Clinical Research - 1109Cerritos, California, United StatesRecruiting
Emad Ibrahim MD Inc. - 1147Redlands, California, United StatesRecruiting
UC Davis Comprehensive Cancer Center - 1103Sacramento, California, United StatesRecruiting
Bass Medical Group - 1155Walnut Creek, California, United StatesRecruiting
Nuvance Health - 1118Norwalk, Connecticut, United StatesRecruiting
D&H Cancer Research Center LLC - 1153Margate, Florida, United StatesRecruiting
Ocala Oncology Center PL - 1102Ocala, Florida, United StatesRecruiting
AdventHealth Cancer Institute - 1105Orlando, Florida, United StatesRecruiting
Orlando Health - 1130Orlando, Florida, United StatesRecruiting
Florida Cancer Specialists -South - 1126Sarasota, Florida, United StatesRecruiting

+ 140 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05671510