ClinicaliQ Trial Snapshot
- JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC — Recruiting • Phase III • Oncology • NCT04892173.
- Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Eligibility Snapshot
- : * Age greater than or equal to (>=) 60 years old * Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab * Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC * One primary tumor lesion amendable for intratumoral injection * Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following): 1. Estimated creatinine clearance >= 30 and less than (= 2 hearing loss or tinnitus, 3. Grade >= 2 peripheral neuropathy, 4. New York Heart Association Class 3 5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (= 75 years old * Eastern cooperative oncology group (ECOG) performance status 0 to 1 * Life expectancy >= 6 months
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.