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JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

StatusRecruiting
PhasePhase 3
Started2021-12-10
View on ClinicalTrials.gov ↗
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).

Amendment history 2 changes detected by DataLookout

2026-04-28
Primary endpoint(s) modified
WasProgression-free Survival (PFS)
NowProgression-free Survival (PFS) Based on Independent Central Review (ICR)
2026-04-28
Primary completion pushed: 2026-06-30 → 2028-06-30
Trial Details
NCT Number NCT04892173
Lead Sponsor Johnson & Johnson Enterprise Innovation Inc.
Conditions Carcinoma, Squamous Cell
Enrollment 500 participants
Start Date 2021-12-10
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-28