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Clinical Trials in India / NCT04892173
Recruiting Phase 3

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

NCT04892173 · tracked via the Priya Life Science India tracker
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Phase
Phase 3
Started
2021-12-10
Last updated
2026-08-28

Condition(s) studied

Carcinoma, Squamous Cell

Investigational drug(s) / intervention(s)

JNJ-90301900 (NBTXR3)CetuximabRadiation Therapy

JNJ-90301900 (NBTXR3): Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.

Cetuximab: Solution for infusion

Radiation Therapy: Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

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).

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age greater than or equal to (\>=) 60 years old * Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab * Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC * One primary tumor lesion amendable for intratumoral injection * Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following): 1. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation), 2. Grade \>= 2 hearing loss or tinnitus, 3. Grade \>= 2 peripheral neuropathy, 4. New York Heart Association Class 3 5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14 or Aged \>= 75 years old * Eastern cooperative oncology group (ECOG) performance status 0 to 1 * Life expectancy \>= 6 months Exclusion Criteria: * Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin * Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC * Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy * 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 * Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Primary outcome measure(s)

Trial sites (193)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
City of Hope Duarte California Recruiting
University of California at San Diego Moores Cancer Center La Jolla California Recruiting
Memorial Radiation Oncology Medical Group Laguna Hills Laguna Hills California Completed
UCLA Hematology Oncology Los Angeles California Recruiting
Hoag Memorial Hospital Newport Beach California Completed
University of California San Francisco San Francisco California Recruiting
George Washington University Cancer Center Washington D.C. District of Columbia Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
University of Kentucky Markey Cancer Center Lexington Kentucky Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Christus St. Vincent Regional Cancer Center Santa Fe New Mexico Completed
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center New York New York Completed
Richmond University Medical Center Staten Island New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Atrium Health Levine Cancer Institute Charlotte North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
Oregon Health And Science University Portland Oregon Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia Pennsylvania Recruiting
University of Virginia Charlottesville Virginia Recruiting
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University Norfolk Virginia Recruiting
Medizinische Universitat Graz Graz Austria Completed
Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Austria Recruiting
Medizinische Universitaet Wien Vienna Austria Recruiting
Cliniques Universitaires Saint Luc Brussels Belgium Recruiting
Grand Hopital De Charleroi Site Les Viviers Charleroi Belgium Recruiting
Universitair Ziekenhuis Leuven Leuven Belgium Recruiting
Fundacao Pio XII Barretos Brazil Recruiting
Nucleo de Ensino e Pesquisa do Instituto Mario Penna Belo Horizonte Brazil Recruiting
Centro Regional Integrado de Oncologia CRIO Fortaleza Brazil Completed
Instituto Do Cancer Do Ceara Fortaleza Brazil Recruiting
Fundacao Sao Francisco Xavier Ipatinga Brazil Recruiting
Fundacao Doutor Amaral Carvalho Jaú Brazil Recruiting
Hospital do Cancer de Londrina Londrina Brazil Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil Recruiting

+ 153 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04892173 on ClinicalTrials.gov ↗ ← All trials in India