NCT04892173

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 LA-HNSCC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Johnson & Johnson Enterprise Innovation Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Participants will undergo a screening assessment over a period of less than or equal to (\<=) 28 days to determine eligibility. Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio: * Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab * Arm B: Investigator's choice of RT alone or RT in combination with cetuximab All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period. An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Aged

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-10
• Primary completion: 2026-06-30
• Completion: 2028-06-30
• First posted: 2021-05-19
• Last updated: 2026-03-13

Locations

189 sites across 27 countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, India, Israel, Japan, Philippines, Portugal, Romania, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study