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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: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by OncoC4.
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 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
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 |
What NCT05671510 shows while recruiting
NCT05671510 is an interventional study that assigns participants to a tested intervention. The registered 630 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT05671510's enrollment target sits among peer trials
630 50th of 454 higher than 403 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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