Nanoray-312: phase III study of NBTXR3 + radiotherapy ± cetuximab in elderly, platinum-ineligible locally advanced HNSCC
Christophe Le Tourneau, Zoltán Takácsi‐Nagy, Sandra Nuyts, S. Thureau, Feng Liu, Caroline Hoffmann, Trevor Hackman, Maria Lesnik, Anaïs Debard, Laetitia Finzi, Kiran Devisetty, Omar I. Vivar, Leonard A. Farber, France Nguyen, X. Liem, Eter Natelauri, Amanda Psyrri, Martin Burian, Jinming Yu, Sue S. Yom
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.