Phase 3 Study of NBTXR3 Injection Activated by Radiotherapy With or Without Cetuximab in Elderly Patients Unsuitable for Platinum Chemotherapy With Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and efficacy of JNJ-90301900 NBTXR3 activated by radiotherapy, with or without cetuximab, compared to radiotherapy with or without cetuximab alone. This Phase 3 study focuses on elderly participants aged 60 years and older who have locally advanced head and neck squamous cell carcinoma LA-HNSCC and are ineligible for platinum chemotherapy. The study is randomized and open-label, aiming to provide insights for this specific patient group. Participants will be assigned to one of two groups. One group receives an intratumoral or intranodal injection of JNJ-90301900 NBTXR3 at a dose of 33% of the gross tumor volume, followed by radiotherapy alone or combined with cetuximab, based on the investigators choice. The other group receives radiotherapy alone or combined with cetuximab. Radiotherapy is intensity-modulated, delivering 70 Gray over 35 fractions across 7 weeks. During the study, participants will be monitored for up to 48 months following the first randomized participant. Researchers will assess progression-free survival as the primary outcome, measured at 30 months, along with secondary outcomes such as overall survival, local-regional control, distant control, quality of life, safety, response rates, and head and neck cancer-specific survival. Regular assessments include clinical evaluations and quality of life questionnaires to track treatment effects and safety over time.

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