LUMIRAY
Head and neck cancer
INTRATUMORAL STUDY.
A Phase 1 study of JNJ-90301900 in combination with concurrent chemoradiation therapy in participants with locally advanced HNSCC
A Phase 1 study of JNJ-90301900 in combination with concurrent chemoradiation therapy in participants with locally advanced HNSCC
Phase
Compound
JNJ-90301900 (NBTXR3) + cisplatin + IMRT
NCT identifier
NCT07219212
Enrollment
N=~30
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*:
- Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
- ≥50% of total GTV and ≥1 target lesion per RECIST v1.1 is amenable for JNJ-90301900 injection
- Ages 18–74
- Stage III, IVA or IVB HNSCC
- ECOG PS 0–1
Study
design
Primary outcome:
- AEs by severity
Secondary outcomes:
- Objective response rate
- CR
- DCR
- Injected tumor response rate
- Time to locoregional failure
- Time to distant failure
- PFS
- Number of patients with post-radiation neck dissection or primary salvage surgery
*Not a complete list of inclusion and exclusion criteria.
AE, adverse event; CR, complete response; DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; GTV, gross tumor volume; HNSCC, head and neck squamous cell carcinoma; IMRT, intensity modulated radiation therapy; PFS, progression-free survival; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumors.