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Study of NBTXR3 and Cetuximab for Elderly Patients with Advanced Head and Neck Cancer Ineligible for Platinum Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Locally Advanced Head and Neck Squamous Cell Carcinoma. This is a condition where cancer cells form in the tissues of the head and neck area. The study is testing a treatment involving a substance called JNJ-90301900, also known as NBTXR3, which is injected directly into the tumor. This treatment is being tested with or without the use of another medication called cetuximab, which is given through an infusion into a vein. The purpose of the study is to evaluate how well these treatments work in improving survival outcomes for patients who cannot receive a common chemotherapy treatment based on platinum.

Participants in the study will receive either the NBTXR3 treatment activated by radiotherapy, with or without cetuximab, or they will receive radiotherapy with or without cetuximab alone. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. The study will compare the outcomes of these different treatment options to see which is more effective in preventing the cancer from coming back or spreading.

The study will follow participants over a period of time to monitor their health and the progression of their cancer. The main goal is to see how long patients live without the cancer getting worse, which is known as progression-free survival. This information will help doctors understand the best treatment options for patients with this type of cancer who are not able to undergo standard chemotherapy treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, medical condition, and other criteria.

    The medical condition being studied is locally advanced head and neck squamous cell carcinoma.

  2. Step 2

    Treatment plan discussion

    A treatment plan will be discussed, which may involve intratumoral injection of JNJ-90301900 (also known as NBTXR3) and radiotherapy.

    The plan may also include the use of cetuximab, a medication given through an intravenous infusion.

  3. Step 3

    Treatment administration

    The treatment involves injecting JNJ-90301900 directly into the tumor. This is known as intratumoral use.

    If included in the plan, cetuximab will be administered through an intravenous infusion.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the response to treatment and any side effects.

    Follow-up appointments will be scheduled to evaluate progress and make any necessary adjustments to the treatment plan.

  5. Step 5

    End of trial

    The trial is expected to conclude by June 30, 2027.

    Final assessments will be conducted to determine the overall outcomes of the treatment.

Who can join the trial?

9 criteria

  • Must be 60 years old or older.
  • Must have a type of cancer called squamous cell carcinoma located in the oral cavity, oropharynx, hypopharynx, or supraglottic larynx, and be a candidate for radiation therapy, with or without a drug called cetuximab.
  • Must have a clinical stage of T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC. This refers to the size and extent of the cancer.
  • Must have one primary tumor that can be directly injected with the treatment.
  • Must be ineligible to receive a type of chemotherapy called platinum-based chemotherapy with radiation. This includes:
    • Having an estimated creatinine clearance (a measure of kidney function) between 30 and 50 mL/min, or having significant hearing loss, tinnitus (ringing in the ears), or peripheral neuropathy (nerve damage).
    • Having an ECOG Performance Status of 2, which means being able to walk and capable of all self-care but unable to carry out any work activities.
    • Having a New York Heart Association Class 3, which indicates a certain level of heart failure.
    • Being aged 70-74 years old with a Geriatric 8 (G8) score of 14 or less, which is a tool used to assess the health status of older adults.
    • Being 75 years old or older.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer that is not Locally Advanced Head & Neck Squamous Cell Carcinoma cannot participate.
  • Patients who have received any other experimental treatment within the last 30 days are not eligible.
  • Patients with severe, uncontrolled medical conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with known allergies to the study drugs or similar compounds are not eligible.
  • Patients with active infections that require treatment are excluded.
  • Patients who have had a major surgery within the last 4 weeks are not eligible.
  • Patients with a history of other significant health issues that could affect participation are excluded.
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Investigated drugs

  • NBTXR3

    is a special type of treatment that is injected directly into the tumor. It is designed to make cancer cells more sensitive to radiation therapy. This means that when the tumor is exposed to radiation, the treatment helps to enhance the effects of the radiation, potentially making it more effective at killing cancer cells.

  • Cetuximab

    is a medication used to treat certain types of cancer. It works by targeting and blocking a specific protein on the surface of cancer cells, which can slow down or stop the growth of the cancer. In this trial, cetuximab is used in combination with radiation therapy to see if it can improve treatment outcomes for patients who cannot undergo platinum-based chemotherapy.

What is already known about the treatment

NBTXR3 – NBTXR3 is administered directly into the tumor through an injection, and it is activated by radiotherapy, which can be used alone or with a drug called cetuximab. This medication is currently being studied in clinical trials for its effectiveness in treating elderly patients with a type of cancer called locally advanced head and neck squamous cell carcinoma, especially those who cannot undergo standard platinum-based chemotherapy. NBTXR3 works by enhancing the effects of radiotherapy at the molecular level, making cancer cells more sensitive to radiation, which helps to destroy them more effectively. It is classified as a radio-enhancer, a type of drug that boosts the impact of radiation therapy.

Investigated diseases

Locally Advanced Head and Neck Squamous Cell Carcinoma – This disease is a type of cancer that occurs in the squamous cells lining the surfaces of the head and neck region. It is considered locally advanced when the cancer has spread from its original site to nearby tissues or lymph nodes but not to distant parts of the body. The progression of this carcinoma involves the growth of tumors in areas such as the throat, mouth, or nasal passages. As the disease advances, it can cause symptoms like difficulty swallowing, changes in voice, or persistent sore throat. The cancer may continue to grow and invade surrounding structures, potentially affecting breathing or speech. Over time, it can lead to further complications if not managed effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520386-31-00Protocol codeNANORAY-312Estimated enrolment507 patientsSponsorJohnson & Johnson Enterprise Innovation Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).