Recruiting
Phase 3

JNJ-90301900 & Cetuximab

Sponsor:

Johnson & Johnson Enterprise Innovation Inc.

Code:

NCT04892173

Conditions

Carcinoma, Squamous Cell

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

JNJ-90301900 (NBTXR3)

Cetuximab

Radiation Therapy

Study Details

Brief summary:

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).

Conditions

Carcinoma, Squamous Cell

Study ID

NCT04892173

Start date

Dec 10, 2021

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: JNJ-90301900 (NBTXR3)

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.

active comparator: Arm B: RT alone or RT in combination with cetuximab

Investigator's choice of RT alone or RT in combination with cetuximab.

Interventions

JNJ-90301900 (NBTXR3)

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

Cetuximab

Solution for infusion

Radiation Therapy

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

Primary outcome measure

  • Progression-free Survival (PFS) Based on Independent Central Review (ICR) [ Time Frame: 30 months following first randomized participant ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

City of Hope

Recruiting

Duarte, California, United States, 91010

University of California at San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

UCLA Hematology Oncology

Recruiting

Los Angeles, California, United States, 90095

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

George Washington University Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20052

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

University of Kentucky Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

University of Pennsylvania Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23507

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • LA-HNSCC
  • NBTXR3
  • hafnium oxide
  • radioenhancer
  • Radiotherapy
  • RT
  • HNSCC
  • radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Johnson & Johnson Enterprise Innovation Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.