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

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).

Eligibility

Age range

60+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  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.

• Drug
  Cetuximab

  Solution for infusion

• Radiation
  Radiation Therapy

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

Locations (190)