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NCT Number: NCT04892173

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

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).

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Key information

Conditions

Carcinoma, Squamous Cell Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universitat Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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

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

Treatment and study plan

JNJ-90301900 (NBTXR3)

Drug

Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.

Other names: Functionalized hafnium oxide nanoparticles, NBTXR3

Cetuximab

Drug

Solution for infusion

Other names: Erbitux

radiation therapy

Radiation

Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Primary outcomes

  1. Progression-free Survival (PFS) Based on Independent Central Review (ICR)

    Time frame: 30 months following first randomized participant

    PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 48 months following first randomized participant

    Time from randomization to death from any cause.

  2. Local-regional control

    Time frame: 48 months following first randomized participant

    Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.

  3. Distant control

    Time frame: 48 months following first randomized participant

    Time to distant progression: time from randomization to distant progression or death, whichever occurs first.

  4. Quality of Life over time - QLQ H&N35

    Time frame: 48 months following first randomized participant

    Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H&N35).

  5. Quality of Life over time - EQ 5D 5L

    Time frame: 48 months following first randomized participant

    Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.

  6. Safety across duration of study - AEs

    Time frame: 48 months following first randomized participant

    Adverse events (AEs).

  7. Objective Response Rate (ORR)

    Time frame: 48 months following first randomized participant

    Rate of complete response (CR)+partial response (PR) [RESIST 1.1].

  8. Duration of Overall Response

    Time frame: 48 months following first randomized participant

    Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.

  9. Head and Neck Cancer Specific Event-Free Survival

    Time frame: 48 months following first randomized participant

    Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first.

  10. Head and Neck Cancer-Specific Survival

    Time frame: 48 months following first randomized participant

    Time from randomization to head and neck cancer-related death.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 19, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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