OncoMatch/Clinical Trials/NCT04892173
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Is NCT04892173 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including JNJ-90301900 (NBTXR3) and Cetuximab for carcinoma, squamous cell.
Treatment: JNJ-90301900 (NBTXR3) · Cetuximab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Disease stage
Required: Stage T3-4 NX, T2 N2-3 (other)
Excluded: Stage T1-2 N0, T2 N1
Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: surgery, radiation therapy, and/or chemotherapy for loco-regionally recurrent head & neck cancer
Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
Cannot have received: primary malignancy (including second synchronous head & neck cancer)
Exception: within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
Lab requirements
Kidney function
Estimated creatinine clearance >= 30 and < 50 mL/min (per Cockcroft-Gault equation)
Cardiac function
New York Heart Association Class 3
Estimated creatinine clearance >= 30 and < 50 mL/min (per Cockcroft-Gault equation); New York Heart Association Class 3
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- City of Hope · Duarte, California
- University of California at San Diego Moores Cancer Center · La Jolla, California
- Memorial Radiation Oncology Medical Group Laguna Hills · Laguna Hills, California
- UCLA Hematology Oncology · Los Angeles, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04892173 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgery, radiation therapy, and/or chemotherapy for loco-regionally recurrent head & neck cancer, primary malignancy (including second synchronous head & neck cancer) disqualifies patients from enrollment.
What disease stage is eligible?
Stage T3-4 NX or T2 N2-3 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify