๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (NCT05671510)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: OncoC4, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: XCancer/Dothan Hematology & Oncology - 1114 โ€” Dothan, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (152 Sites)

Showing the first 25 of 152 sites.

  • XCancer/Dothan Hematology & Oncology - 1114 โ€” Dothan, Alabama
  • Genesis Cancer and Blood Institute - 1123 โ€” Russellville, Arkansas
  • The Oncology Institute (TOI) Clinical Research - 1109 โ€” Cerritos, California
  • Emad Ibrahim MD Inc. - 1147 โ€” Redlands, California
  • UC Davis Comprehensive Cancer Center - 1103 โ€” Sacramento, California
  • Bass Medical Group - 1155 โ€” Walnut Creek, California
  • Nuvance Health - 1118 โ€” Norwalk, Connecticut
  • D&H Cancer Research Center LLC - 1153 โ€” Margate, Florida
  • Ocala Oncology Center PL - 1102 โ€” Ocala, Florida
  • AdventHealth Cancer Institute - 1105 โ€” Orlando, Florida
  • Orlando Health - 1130 โ€” Orlando, Florida
  • Florida Cancer Specialists -South - 1126 โ€” Sarasota, Florida
  • Florida Cancer Specialists -North - 1125 โ€” The Villages, Florida
  • Florida Cancer Specialists -East - 1124 โ€” West Palm Beach, Florida
  • Orchard Healthcare Research, Inc. - 1116 โ€” Skokie, Illinois
  • Springfield Clinic - The Cancer Center - 1110 โ€” Springfield, Illinois
  • Fort Wayne Medical Oncology - 1133 โ€” Fort Wayne, Indiana
  • Deaconess Chancellor Center for Oncology - 1131 โ€” Newburgh, Indiana
  • Cotton O'Neil Clinical Research Center - 1151 โ€” Topeka, Kansas
  • University of Kentucky - Markey Cancer Center - 1112 โ€” Lexington, Kentucky
  • Norton Cancer Institute - 1108 โ€” Louisville, Kentucky
  • Jefferson City Medical Group - 1145 โ€” Jefferson City, Missouri
  • MidAmerica Cancer Care - 1163 โ€” Kansas City, Missouri
  • Astera Cancer Care - 1128 โ€” East Brunswick, New Jersey
  • Duke University Medical Center - 1158 โ€” Durham, North Carolina

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—