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ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
NCT05671510 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoC4, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05671510 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05671510?
The interventions under investigation include: Docetaxel (DRUG), Gotistobart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05671510?
This trial is sponsored by OncoC4, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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