UCSF Squamous Cell Carcinoma Trial: JNJ‑90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA‑HNSCC
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).
This global, open‑label, Phase 3 randomized trial compares JNJ‑90301900 (NBTXR3) with radiotherapy ± cetuximab versus radiotherapy ± cetuximab alone in treatment‑naïve, platinum‑ineligible, elderly patients with locally advanced head‑and‑neck squamous cell carcinoma. The study enrolls approximately 500 participants, is anticipated to end in June 2028, and is run under the Johnson & Johnson Enterprise Innovation Inc. sponsorship.
The study evaluates a novel radio‑enhancer, NBTXR3, which may improve tumor control and reduce toxicity for older patients who cannot receive platinum chemotherapy, potentially expanding therapeutic options for a high‑risk population.
Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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