Nanoray-312: phase III study of NBTXR3 + radiotherapy ± cetuximab in elderly, platinum-ineligible locally advanced HNSCC

Abstract

Elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) are often excluded from clinical trials. However, in an aging population with competing comorbidities, many are ineligible for standard of care cisplatin-based chemoradiotherapy and represent an unmet need for which effective treatments are urgently needed. NBTXR3, a first-in-class intratumoral radioenhancer made of hafnium oxide nanoparticles, enhances the tumor-killing effect of radiotherapy. In this paper, we describe the study design of NANORAY-312, a global, open-label, randomized (1:1) phase III pivotal study comparing NBTXR3 + radiotherapy ± cetuximab (Investigator’s choice) versus radiotherapy ± cetuximab (Investigator’s choice) in 500 eligible patients, aged ≥60 years, with platinum-ineligible LA-HNSCC. The primary endpoint is progression-free survival, with a key secondary endpoint being overall survival. Clinical trial registration: https://clinicaltrials.gov identifier is NCT04892173; EudraCT Number: 2021-002163-22.