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Treatment for elderly patients with advanced head and neck cancer using a new drug and radiation

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

Phase 3 Interventional Johnson & Johnson Enterprise Innovation Inc. · NCT04892173

This study is testing a new drug combined with radiation to see if it helps elderly patients with advanced head and neck cancer feel better compared to just radiation or radiation with another drug.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages60 Years and up
SexAll
SponsorJohnson & Johnson Enterprise Innovation Inc. Industry-sponsored
Drugs / interventionscetuximab, chemotherapy, radiation
Locations191 sites (Birmingham, Alabama and 190 other locations)
Trial IDNCT04892173 on ClinicalTrials.gov

What this trial studies

This global, open-label, randomized Phase 3 study aims to evaluate the efficacy and safety of JNJ-90301900 (NBTXR3) in combination with radiation therapy, with or without cetuximab, in treatment-naïve, platinum-ineligible elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Participants will be screened for eligibility and then randomized into two arms: one receiving NBTXR3 with radiation and the other receiving radiation alone or with cetuximab. The treatment will involve a total radiation dose of 70 Gy over 35 fractions, followed by regular follow-up visits for up to two years. The study seeks to determine the potential benefits of this novel approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 60 and above with locally advanced head and neck squamous cell carcinoma who are not suitable for platinum-based chemotherapy.

Not a fit: Patients with carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, or thyroid gland will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for elderly patients with advanced head and neck cancer who are ineligible for platinum-based chemotherapy.

How similar studies have performed: While this approach is novel, similar studies have shown promise in enhancing the efficacy of radiation therapy with novel agents.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 190 other locations

+141 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Squamous CellLA-HNSCCNBTXR3hafnium oxideradioenhancerRadiotherapyRTHNSCC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.