UPCC 06325 A Phase 3 (Pivotal Stage) 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 (NANORAY-312)

Investigating the Effects of Investigational Medication with Radiotherapy for Elderly Patients with Advanced Head and Neck Cancer

Enrolling By Invitation
60 years or above
All
Phase 3
500 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Carcinoma, Squamous Cell
  • Age: 60 years or above
  • Gender: All

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

This study investigates the effectiveness and safety of an investigational medication activated by radiotherapy, with or without cetuximab, for elderly patients who cannot receive platinum-based chemotherapy. The focus is on individuals with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Participants are divided into two study arms to compare the outcomes of the investigational medication and radiotherapy against radiotherapy alone, with the option of adding cetuximab.

Participants in this study will receive radiotherapy, which uses high-energy rays to target and destroy cancer cells. Some participants may also receive cetuximab, a medication that targets specific proteins on cancer cells. The investigational medication is injected directly into the tumor to enhance the effects of radiotherapy. This study will involve regular monitoring and assessments to evaluate treatment effects and safety.

  • Who can participate: Participants must be 60 years or older with confirmed squamous cell carcinoma of certain head and neck areas. They must be candidates for radiation therapy, with a primary tumor suitable for injection, and unable to receive platinum-based chemotherapy due to specific health criteria.
  • Study details: Participants will undergo radiotherapy and may receive cetuximab or the investigational medication. The investigational medication is injected into the tumor, and cetuximab is administered to enhance treatment.
Updated on 06 Jul 2026. Study ID: 25-1155
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