ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Trial status:Recruiting
Study Identifier:
PRESERVE-003
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
OncoC4, Inc.
Recruiting
Trial details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+
Estimated Trial Date
Jun 2023 - Jun 2026
Protocol summary
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.
Trial locations
Location
Status
Location
XCancer/Dothan Hematology & Oncology - 1114
Dothan, Alabama, United States, 36303
Status
Recruiting
Location
Genesis Cancer and Blood Institute - 1123
Russellville, Arkansas, United States, 72801
Status
Recruiting
Location
The Oncology Institute (TOI) Clinical Research - 1109
Cerritos, California, United States, 90703
Status
Recruiting
Location
Emad Ibrahim MD Inc. - 1147
Redlands, California, United States, 92373
Status
Recruiting
Location
UC Davis Comprehensive Cancer Center - 1103
Sacramento, California, United States, 95817
Status
Recruiting
Location
Bass Medical Group - 1155
Walnut Creek, California, United States, 94598
Status
Recruiting