Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

NCT04892173 · View on ClinicalTrials.gov ↗

Study Summary

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Interventions

  • RADIATION Radiation Therapy
  • DRUG Cetuximab
  • DRUG JNJ-90301900 (NBTXR3)

Study Locations (20)

California

  • City of Hope — Duarte
  • University of California at San Diego Moores Cancer Center — La Jolla
  • Memorial Radiation Oncology Medical Group Laguna Hills — Laguna Hills
  • UCLA Hematology Oncology — Los Angeles
  • Hoag Memorial Hospital — Newport Beach
  • University of California San Francisco — San Francisco

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • AdventHealth Orlando — Orlando
  • Moffitt Cancer Center — Tampa

New York

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York
  • Richmond University Medical Center — Staten Island
  • Montefiore Medical Center — The Bronx

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill
  • Atrium Health Levine Cancer Institute — Charlotte

Alabama

  • University of Alabama at Birmingham — Birmingham

District of Columbia

  • George Washington University Cancer Center — Washington D.C.

Georgia

  • Emory University Hospital Midtown — Atlanta

Kentucky

  • University of Kentucky Markey Cancer Center — Lexington

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2021-12-10
Est. Completion 2028-06-30
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04892173

The ClinicalTrials.gov registry entry for NCT04892173 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Enterprise Innovation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Locally Advanced Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Radiation Therapy 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: NCT04892173 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, New York. 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 NCT04892173 about?

NCT04892173 is a clinical study titled "JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC". This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advan...

What is the current status of trial NCT04892173?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2021-12-10. Estimated completion is 2028-06-30.

What conditions does trial NCT04892173 study?

This clinical trial studies the following conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma, Aged. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04892173?

The interventions under investigation include: Radiation Therapy (RADIATION), Cetuximab (DRUG), JNJ-90301900 (NBTXR3) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04892173?

This trial is sponsored by Johnson & Johnson Enterprise Innovation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04892173 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial