ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
Public ClinicalTrials.gov record NCT05671510. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05671510
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 630 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2023
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2028
- Last update posted
- Aug 12, 2026
2023 – 2028
United States locations
- U.S. sites
- 46
- U.S. states
- 20
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| XCancer/Dothan Hematology & Oncology - 1114 | Dothan | Alabama | 36303 | — |
| Genesis Cancer and Blood Institute - 1123 | Russellville | Arkansas | 72801 | — |
| The Oncology Institute (TOI) Clinical Research - 1109 | Cerritos | California | 90703 | — |
| Emad Ibrahim MD Inc. - 1147 | Redlands | California | 92373 | — |
| UC Davis Comprehensive Cancer Center - 1103 | Sacramento | California | 95817 | — |
| Bass Medical Group - 1155 | Walnut Creek | California | 94598 | — |
| Nuvance Health - 1118 | Norwalk | Connecticut | 06850 | — |
| D&H Cancer Research Center LLC - 1153 | Margate | Florida | 33063 | — |
| Ocala Oncology Center PL - 1102 | Ocala | Florida | 34474 | — |
| AdventHealth Cancer Institute - 1105 | Orlando | Florida | 32804 | — |
| Orlando Health - 1130 | Orlando | Florida | 32806 | — |
| Florida Cancer Specialists -South - 1126 | Sarasota | Florida | 34232 | — |
| Florida Cancer Specialists -North - 1125 | The Villages | Florida | 32159 | — |
| Florida Cancer Specialists -East - 1124 | West Palm Beach | Florida | 33401 | — |
| Orchard Healthcare Research, Inc. - 1116 | Skokie | Illinois | 60077 | — |
| Springfield Clinic - The Cancer Center - 1110 | Springfield | Illinois | 62702 | — |
| Fort Wayne Medical Oncology - 1133 | Fort Wayne | Indiana | 46805 | — |
| Deaconess Chancellor Center for Oncology - 1131 | Newburgh | Indiana | 47630 | — |
| Cotton O'Neil Clinical Research Center - 1151 | Topeka | Kansas | 66606 | — |
| University of Kentucky - Markey Cancer Center - 1112 | Lexington | Kentucky | 40536 | — |
| Norton Cancer Institute - 1108 | Louisville | Kentucky | 40202 | — |
| Jefferson City Medical Group - 1145 | Jefferson City | Missouri | 65109 | — |
| MidAmerica Cancer Care - 1163 | Kansas City | Missouri | 64132 | — |
| Astera Cancer Care - 1128 | East Brunswick | New Jersey | 08816 | — |
| Duke University Medical Center - 1158 | Durham | North Carolina | 27710 | — |
| Miami Valley Hospital - 1115 | Centerville | Ohio | 45459 | — |
| University of Cincinnati Cancer Center - 1107 | Cincinnati | Ohio | 45219 | — |
| The Ohio State University James Cancer Center - 1104 | Columbus | Ohio | 43210 | — |
| Tri County Hematology & Oncology Associates, Inc - 1156 | Massillon | Ohio | 44646 | — |
| Oklahoma Cancer Specialists and Research Institute - 1154 | Tulsa | Oklahoma | 74146 | — |
| Oncology Associates of Oregon - 1138 | Eugene | Oregon | 97401 | — |
| St. Luke's University Health Network - 1179 | Bethlehem | Pennsylvania | 18015 | — |
| Donald Guthrie Foundation - 1135 | Sayre | Pennsylvania | 18840 | — |
| Cancer Care Associates of York, Inc. - 1113 | York | Pennsylvania | 17403 | — |
| University of Tennessee Medical Center - 1146 | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119 | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140 | Dallas | Texas | 75246 | — |
| Texas Oncology - Denison - 1139 | Denison | Texas | 75020 | — |
| Oncology Consultants, P.A. - 1120 | Houston | Texas | 77024 | — |
| Oncology and Hematology of South Texas - 1165 | Laredo | Texas | 78041 | — |
| Texas Oncology - McAllen - 1132 | McAllen | Texas | 78503 | — |
| Texas Oncology -San Antonio - 1122 | San Antonio | Texas | 78240 | — |
| NEXT Oncology - Virginia - 1129 | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Institute - 1149 | Henrico | Virginia | 23226 | — |
| Virginia Oncology Associates - 1136 | Norfolk | Virginia | 23502 | — |
| West Virginia University Cancer Institute - 1172 | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05671510, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05671510 live on ClinicalTrials.gov.