Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04892173

RecruitingPhase 3

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Conditions: Carcinoma, Squamous Cell

Interventions: JNJ-90301900 (NBTXR3), Cetuximab, Radiation Therapy

Countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (191)
  • Birmingham, Alabama, United States
  • Duarte, California, United States
  • La Jolla, California, United States
  • Laguna Hills, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • San Francisco, California, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Lexington, Kentucky, United States
  • Boston, Massachusetts, United States
  • Santa Fe, New Mexico, United States
  • New York, New York, United States
  • Staten Island, New York, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Charlottesville, Virginia, United States
  • Norfolk, Virginia, United States
  • Graz, Austria
  • Linz, Austria
  • Vienna, Austria
  • Brussels, Belgium
  • + 161 more on CT.gov