NANORAY-312
Head and neck cancer
INTRATUMORAL STUDY.
A Phase 3, randomized, open-label study of JNJ-90301900 (NBTXR3) + RT ± cetuximab in treatment-naive, platinum-ineligible elderly participants with locally advanced HNSCC
A Phase 3, randomized, open-label study of JNJ-90301900 (NBTXR3) + RT ± cetuximab in treatment-naive, platinum-ineligible elderly participants with locally advanced HNSCC
Phase
Compound
JNJ-90301900 (NBTXR3) + RT ± cetuximabIntratumoral study
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 (clinical stage: T3–4 NX or T2 N2–3)
- Treatment naive
- Ineligible for platinum-based chemotherapy
- Eligible for definitive RT
- One primary tumor lesion amenable for intratumoral injection
- ECOG 0 or 1
- Life expectancy ≥6 months
Study
design
Primary outcome:
- PFS
Secondary outcomes†:
- OS
- ORR
- Duration of overall response
- Local-regional and distant control
- QoL
- Safety
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
ECOG PS,
Eastern Cooperative Oncology Group performance status; HNSCC, head and neck squamous cell carcinoma; ORR, objective
response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; R, randomized; RT,
radiotherapy.