IndicationHead and Neck Cancer
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NANORAY-312 a global, open-label, two-arm, randomized, Investigator’s Choice phase III registration study that is designed to investigate the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, chemotherapy-ineligible elderly patients with locally-advanced head and neck squamous cell carcinoma (LA-HNSCC).
Participants in NANORAY-312 were be treated with NBTXR3 at a 1:1 ratio after an Investigator’s Choice of radiotherapy alone or radiotherapy in combination with cetuximab. NANORAY-312 enrolled 500 patients across sites in the United States, Europe, and Asia. The primary endpoint of the pivotal study was Progression-free Survival (PFS) and key secondary endpoints include Overall Survival (OS), response rates, and quality of life.