ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Recruiting now · Phase 3
Conditions studied: Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT05671510
- Run by
- OncoC4, Inc.
- People needed
- 630
- Starts
- 2023-06-28
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Genesis Cancer and Blood Institute - 1123 — Russellville, Arkansas, United States (enrolling)
- The Oncology Institute (TOI) Clinical Research - 1109 — Cerritos, California, United States (enrolling)
- Emad Ibrahim MD Inc. - 1147 — Redlands, California, United States (enrolling)
- UC Davis Comprehensive Cancer Center - 1103 — Sacramento, California, United States (enrolling)
- Bass Medical Group - 1155 — Walnut Creek, California, United States (enrolling)
- Nuvance Health - 1118 — Norwalk, Connecticut, United States (enrolling)
- D&H Cancer Research Center LLC - 1153 — Margate, Florida, United States (enrolling)
- Ocala Oncology Center PL - 1102 — Ocala, Florida, United States (enrolling)
- AdventHealth Cancer Institute - 1105 — Orlando, Florida, United States (enrolling)
- Orlando Health - 1130 — Orlando, Florida, United States (enrolling)
- Florida Cancer Specialists -South - 1126 — Sarasota, Florida, United States (enrolling)
- Florida Cancer Specialists -North - 1125 — The Villages, Florida, United States (enrolling)
- Florida Cancer Specialists -East - 1124 — West Palm Beach, Florida, United States (enrolling)
- Orchard Healthcare Research, Inc. - 1116 — Skokie, Illinois, United States (enrolling)
- Springfield Clinic - The Cancer Center - 1110 — Springfield, Illinois, United States (enrolling)
- Fort Wayne Medical Oncology - 1133 — Fort Wayne, Indiana, United States (enrolling)
- Deaconess Chancellor Center for Oncology - 1131 — Newburgh, Indiana, United States (enrolling)
- Cotton O'Neil Clinical Research Center - 1151 — Topeka, Kansas, United States (enrolling)
- University of Kentucky - Markey Cancer Center - 1112 — Lexington, Kentucky, United States (enrolling)
- Norton Cancer Institute - 1108 — Louisville, Kentucky, United States (enrolling)
- Jefferson City Medical Group - 1145 — Jefferson City, Missouri, United States (enrolling)
- MidAmerica Cancer Care - 1163 — Kansas City, Missouri, United States (enrolling)
- Astera Cancer Care - 1128 — East Brunswick, New Jersey, United States (enrolling)
- Duke University Medical Center - 1158 — Durham, North Carolina, United States (enrolling)
- XCancer/Dothan Hematology & Oncology - 1114 — Dothan, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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