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NCT05671510 · ClinicalTrials.gov registry record · Phase 3
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by OncoC4.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
- 20
- Study locations
NCT05671510 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by OncoC4. The registered enrollment target is 630 participants, roughly in line with the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 9 states.
The verdict
NCT05671510, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by OncoC4.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Gotistobart
Study Locations (20)
Florida
- D&H Cancer Research Center LLC - 1153 - Margate
- Ocala Oncology Center PL - 1102 - Ocala
- AdventHealth Cancer Institute - 1105 - Orlando
- Orlando Health - 1130 - Orlando
- Florida Cancer Specialists -South - 1126 - Sarasota
- Florida Cancer Specialists -North - 1125 - The Villages
- Florida Cancer Specialists -East - 1124 - West Palm Beach
California
- The Oncology Institute (TOI) Clinical Research - 1109 - Cerritos
- Emad Ibrahim MD Inc. - 1147 - Redlands
- UC Davis Comprehensive Cancer Center - 1103 - Sacramento
- Bass Medical Group - 1155 - Walnut Creek
Illinois
- Orchard Healthcare Research, Inc. - 1116 - Skokie
- Springfield Clinic - The Cancer Center - 1110 - Springfield
Indiana
- Fort Wayne Medical Oncology - 1133 - Fort Wayne
- Deaconess Chancellor Center for Oncology - 1131 - Newburgh
Alabama
- XCancer/Dothan Hematology & Oncology - 1114 - Dothan
Arkansas
- Genesis Cancer and Blood Institute - 1123 - Russellville
Connecticut
- Nuvance Health - 1118 - Norwalk
Kansas
- Cotton O'Neil Clinical Research Center - 1151 - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2023-06-28 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05671510
The ClinicalTrials.gov registry entry for NCT05671510 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The listed sponsor is OncoC4, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT05671510 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05671510 about?
NCT05671510 is a clinical study titled "ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors". 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 got...
What is the current status of trial NCT05671510?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 630 participants. The study started on 2023-06-28. Estimated completion is 2028-08-31.
What conditions does trial NCT05671510 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05671510?
The interventions under investigation include: Docetaxel (DRUG), Gotistobart (DRUG).
Who is sponsoring clinical trial NCT05671510?
This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05671510 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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