LUMIRAY
Head and neck cancer
INTRATUMORAL STUDY.
A Phase 1b, open-label study of JNJ-90301900 in combination with concurrent chemoradiation therapy in participants with locally advanced HNSCC
A Phase 1b, open-label study of JNJ-90301900 in combination with concurrent chemoradiation therapy in participants with locally advanced HNSCC
Phase
b
Compound
JNJ-90301900 (NBTXR3) + cisplatin + IMRTIntratumoral study
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
- ≥1 target lesion per RECIST v1.1
- Ages 18–74 years
- Stage III, IVA or IVB HNSCC
- ECOG PS 0 or 1
Study
design
Primary outcome:
- AEs by severity
Secondary outcomes:
- ORR
- 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 performance status; HNSCC, head and neck squamous cell
carcinoma; IMRT, intensity-modulated radiation therapy; ORR, objective response rate; PFS, progression-free
survival; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1.