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NCT04892173 · ClinicalTrials.gov registry record · Phase 3
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
A Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma and Aged, sponsored by Johnson & Johnson Enterprise Innovation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT04892173: Recruiting Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma and Aged, sponsored by Johnson & Johnson Enterprise Innovation.
NCT04892173 is a Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma and Aged that is actively recruiting participants, run by Johnson & Johnson Enterprise Innovation. The registered enrollment target is 500 participants, above the 248-participant average among 5 other Locally Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (102% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04892173, a Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma and Aged, is actively recruiting participants, sponsored by Johnson & Johnson Enterprise Innovation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
What NCT04892173 shows while recruiting
NCT04892173 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 248-participant average among 5 other Locally Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (102% higher).
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.
NCT04892173 names 20 study sites across 10 states, led by California, Florida, New York.
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.
What interventions are being tested in trial NCT04892173?
The interventions under investigation include: Radiation Therapy (RADIATION), Cetuximab (DRUG), JNJ-90301900 (NBTXR3) (DRUG).
Who is sponsoring clinical trial NCT04892173?
This trial is sponsored by Johnson & Johnson Enterprise Innovation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
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