A Phase 3 study of NBTXR3 with or without cetuximab in LA-HNSCC
Research type
Research Study
Full title
A Phase 3 (Pivotal Stage) 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
IRAS ID
1011758
Contact name
Jack Brady
Contact email
Sponsor organisation
Janssen Global Clinical Operations, Janssen Research and Development
Eudract number
2024-530386-31
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to evaluate the safety and effectiveness of JNJ-90301900 (NBTRX3) injected directly into tumour and used together with radiotherapy or radiotherapy combined with cetuximab, and how it compares with radiotherapy alone, or radiotherapy combined with cetuximab in patients suffering from head and neck squamous cell cancer.
JNJ-90301900 (NBTRX3) is a radio enhancer composed of hafnium nanoparticles. When injected into a tumour, they may increase the dose of energy within the tumour when exposed to radiotherapy. As a result, this can increase death of cancer cells and tumour shrinkage.
Cetuximab stops growth factor proteins from attaching to cancer cells. This can stop stimulating the cancer cells to divide and grow.This study is split up into three different periods: Screening, Treatment, and Follow-up Period. The screening and treatment period will last around 17 weeks. The follow-up period will last until death, lost to follow-up, withdrawal of consent, or end of study (expected 48 months after first randomised patient), whichever occurs first.
Treatment Period:
Participants in Arm A (with JNJ-90301900 (NBTRX3))
JNJ-90301900 (NBTRX3) will be administered around Day 5 after randomisation. Participants will stay at the clinic for up to 6 hours after the injection for observation. They will return to the clinic at least 24 hours after the injection in order to evaluate how the injected product is located within the tumour
If receiving cetuximab, this will be given around 1 week before the start of radiotherapy.
Radiotherapy will start between Day 10 and Day 19 after randomisation. Participants will have a daily radiotherapy treatments (around 30 minutes) with a rest on the weekends. Consecutive doses of cetuximab (if applicable) will be given during radiotherapy, once per week.
Participants in Arm B (without JNJ-90301900 (NBTRX3)
If receiving cetuximab, this will be given around 1 week before the start of radiotherapy.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0127
Date of REC Opinion
25 Jul 2025
REC opinion
Further Information Favourable Opinion