Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Tests NBTXR3 with radiotherapy for older adults with head and neck cancer
Tests NBTXR3 with radiotherapy in older adults with advanced head and neck cancer.
Key facts
- Who runs it
- Johnson & Johnson Enterprise Innovation Inc.
- Where
- Atlanta, Birmingham, Boston, Chapel Hill, Charlotte, Charlottesville, Cincinnati, Duarte, Jacksonville, La Jolla, Laguna Hills, Lexington, Los Angeles, New York, Newport Beach, Norfolk, Oklahoma City, Orlando, Philadelphia, Portland, San Francisco, Santa Fe, Staten Island, Tampa, The Bronx, and Washington D.C., United StatesSee the 26 sitesAlso in 26 other countries, 170 sites
- Trial code
- Registry title
- JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 500 people, planned
- Started
- 10 Dec 2021
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- JNJ-90301900 (NBTXR3)
- Cetuximab
- Radiation Therapy
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 60 or older with newly diagnosed, locally advanced squamous cell cancer of the head and neck who cannot have platinum-based chemotherapy.
- Age
- 60 years or older
- Sex
- All sexes
- Disease stage
- Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx. Clinical stage T3-4 NX or T2 N2-3 (AJCC 8th edition). One tumor that can be injected directly.
- Earlier treatment
- The trial is looking for people who cannot have platinum-based chemotherapy with radiation. The reasons listed include reduced kidney function, hearing loss or ringing in the ears, nerve damage in the limbs, heart failure (NYHA Class 3), or older age. Cancer that came back after earlier surgery, radiation or chemotherapy cannot be included.
Main reasons for not taking part
- Cancer of the nasopharynx, paranasal sinus, salivary gland or thyroid, or a non-squamous type
- Stage T1-2 N0, T2 N1, or M1 disease
- Head and neck cancer that came back after earlier surgery, radiation or chemotherapy
- Another primary cancer in the last 2 years that could affect the results
- Infection needing antimicrobial treatment within 2 weeks of randomization
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
Where in United States
Also in 26 other countries, 170 sites
- Emory University Hospital MidtownAtlanta, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Boston Medical CenterBoston, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Atrium Health Levine Cancer InstituteCharlotte, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- University of CincinnatiCincinnati, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- Mayo Clinic- JacksonvilleJacksonville, United StatesTaking people
- University of California at San Diego - Moores Cancer CenterLa Jolla, United StatesTaking people
- Memorial Radiation Oncology Medical Group Laguna HillsLaguna Hills, United StatesNo longer taking part
- University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
- UCLA Hematology-OncologyLos Angeles, United StatesTaking people
- Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew York, United StatesNo longer taking part
- Hoag Memorial HospitalNewport Beach, United StatesNo longer taking part
- Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion UniversityNorfolk, United StatesTaking people
- Stephenson Cancer CenterOklahoma City, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
- University of Pennsylvania - Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- CHRISTUS St. Vincent Regional Cancer CenterSanta Fe, United StatesNo longer taking part
- Richmond University Medical CenterStaten Island, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- George Washington University Cancer CenterWashington D.C., United StatesTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Arm A: JNJ-90301900 (NBTXR3)Treatment being tested
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
Treatment: JNJ-90301900 (NBTXR3), Cetuximab, and Radiation Therapy
- Arm B: RT alone or RT in combination with cetuximabExisting treatment, for comparison
Investigator's choice of RT alone or RT in combination with cetuximab.
Treatment: Cetuximab and Radiation Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
- Plain-language title
- Tests NBTXR3 with radiotherapy for older adults with head and neck cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026