Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy (NCT05283226)
A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.
Who can join: Review the eligibility criteria below.
Location: Providence Medical Foundation -Fullerton — Fullerton, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Providence Medical Foundation -Fullerton — Fullerton, California
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California
- Lynn Cancer Center — Boca Raton, Florida
- Miami Cancer Center — Miami, Florida
- Norton Cancer Institute - Downtown — Louisville, Kentucky
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland
- Washington University - Siteman Cancer Center — St Louis, Missouri
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
- Salib Oncology — Easton, Pennsylvania
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
- Daycare Angels under AOH — Mumbai, Maharashtra
- Grant Medical Foundation Ruby Hall Clinic — Pune, Maharashtra
- Basavatarakam Indo American Cancer Hospital & Research Institute — Hyderabad, Telangana
📞 Contact the Study Coordinator
Phone: +91 40 23547532
Email: drpraveen@natcopharma.co.in
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.