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).

Trial Details

NCT ID
NCT04892173
Phase
PHASE3
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • JNJ-90301900 (NBTXR3)
  • Cetuximab
  • Radiation Therapy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • La Jolla, California, United States|32.84727,-117.2742
  • Laguna Hills, California, United States|33.61252,-117.71283
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility 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 radiati…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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