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Back|NCT04892173Recruiting
Official 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 LA-HNSCC

Phase
Phase 3
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Enrollment
500
Timeline
Dec 2021 → Jun 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Age greater than or equal to (\>=) 60 years old
  • 2Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
  • 3Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
  • 4One primary tumor lesion amendable for intratumoral injection
  • 5Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
  • 6Estimated 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, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
  • 7Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14
  • 8Age \>= 75 years old

Exclusion Criteria

  • 1Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
  • 2Non-squamous cell histology
  • 3Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
  • 4Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
  • 5Prior 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
  • 6Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Locations

186 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

City of Hope

Duarte, California 91010

Recruiting

Memorial Radiation Oncology Medical Group Laguna Hills

Laguna Hills, California 92653

Completed
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →