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

Recruiting now · Phase 3

Conditions studied: Carcinoma, Squamous Cell

In brief

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).

Key facts

Study ID

NCT04892173

Run by

Johnson & Johnson Enterprise Innovation Inc.

People needed

500

Starts

2021-12-10

Expected to finish

2028-06-30

Last updated by the study team

2026-07-31

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
• Grade >= 2 hearing loss or tinnitus,
• Grade >= 2 peripheral neuropathy,
• New York Heart Association Class 3
• 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

You may not qualify if…

• 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

Where it is running

• Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University — Norfolk, Virginia, United States (enrolling)
• Medizinische Universitaet Wien — Vienna, Austria (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• UCLA Hematology Oncology — Los Angeles, California, United States (enrolling)
• University of California at San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz, Austria (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• George Washington University Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
• Richmond University Medical Center — Staten Island, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health And Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Cliniques Universitaires Saint Luc — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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