NCT04892173From ClinicalTrials.govRecruiting

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

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

Carcinoma, Squamous Cell

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Enrolment target: 500
Started: 10 December 2021
Main results due: 30 June 2028
Study sites: 193
Registry updated: 25 September 2026

Can you take part?

Aged 60 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(193)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
University of California at San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, United States
Completed
UCLA Hematology Oncology
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital
Newport Beach, California, United States
Completed
University of California San Francisco
San Francisco, California, United States
Recruiting
George Washington University Cancer Center
Washington D.C., District of Columbia, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
AdventHealth Orlando
Orlando, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Completed
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Completed
Richmond University Medical Center
Staten Island, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Recruiting
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
Norfolk, Virginia, United States
Recruiting
Medizinische Universitat Graz
Graz, Austria
Completed
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria
Recruiting
Medizinische Universitaet Wien
Vienna, Austria
Recruiting
Cliniques Universitaires Saint Luc
Brussels, Belgium
Recruiting
Grand Hopital De Charleroi Site Les Viviers
Charleroi, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Fundacao Pio XII
Barretos, Brazil
Recruiting
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, Brazil
Recruiting
Centro Regional Integrado de Oncologia CRIO
Fortaleza, Brazil
Completed
Instituto Do Cancer Do Ceara
Fortaleza, Brazil
Recruiting
Fundacao Sao Francisco Xavier
Ipatinga, Brazil
Recruiting
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Recruiting
Hospital do Cancer de Londrina
Londrina, Brazil
Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Recruiting
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Recruiting
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil
Completed
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Recruiting
Ensino e Terapia de Inovacao Clinica AMO Etica
Salvador, Brazil
Recruiting
Funfarme Sjrp
São José do Rio Preto, Brazil
Recruiting
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil
Recruiting
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil
Recruiting
MHAT Uni Hospital
Panagyurishte, Bulgaria
Completed
Specialized Hospital for Active Treatment in Oncology
Sofia, Bulgaria
Completed
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Recruiting
The Affiliated Hospital of Bengbu Medical College
Bengbu, China
Completed
Xiangya Hospital Central South University
Changsha, China
Completed
Hunan Cancer hospital
Changsha, China
Recruiting
Sichuan Cancer Hospital
Chengdu, China
Recruiting
Dongguan People s Hospital
Dongguan, China
Recruiting
Fujian Medical University Union Hospital
Fuzhou, China
Completed
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Recruiting
Fujian Medical University Fujian Provincial Cancer Hospital
Fuzhou, China
Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China
Recruiting

Showing 60 of 193 sites — filter to narrow it down. 133 of the 193 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04892173. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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