NANORAY-312
Head and neck cancer
INTRATUMORAL STUDY.
A Phase 3 study of JNJ-90301900 (NBTXR3) + RT ± cetuximab in treatment-naive, platinum-ineligible elderly participants with locally advanced HNSCC
A Phase 3 study of JNJ-90301900 (NBTXR3) + RT ± cetuximab in treatment-naive, platinum-ineligible elderly participants with locally advanced HNSCC
Phase
Compound
JNJ-90301900 (NBTXR3) + RT ± cetuximab
NCT identifier
NCT04892173
Enrollment
N=~500
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Age ≥60 years
- Locally advanced disease (Stage III–IVB)
- Treatment naive
- Ineligible for platinum-based chemotherapy
- Eligible for definitive RT
- One primary tumor lesion amenable for intratumoral injection
- Life expectancy ≥6 months
Study
design
Primary outcome:
- PFS
Secondary outcomes:
- OS
- Objective response rate
- Duration of overall response
- Locoregional and distant control
- QoL
- Safety
*Not a complete list of inclusion and exclusion criteria.
HNSCC, head and neck squamous cell carcinoma; OS, overall survival; PFS, progression-free survival; QoL, quality of life; R, randomized; RT, radiotherapy.