Nanoray-312: phase III study of NBTXR3 + radiotherapy ± cetuximab in elderly, platinum-ineligible locally advanced HNSCC
Year: 2025
Type: article
Study design: Study Protocol
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.
Source: UNC Libraries
DOI: 10.17615/tkeg-zk87
Authors: Yom, Sue S., Psyrri, Amanda, Devisetty, Kiran, Vivar, Omar I., Liu, Feng, Liem, Xavier, Hoffmann, Caroline, Debard, Anaïs, Le Tourneau, Christophe, Yu, Jinming, Nuyts, Sandra, Thureau, Sébastien, Natelauri, Eteri, Finzi, Laetitia, Burian, Martin, Farber, Leonard A., Nguyen, France, Hackman, Trevor G., Lesnik, Maria, Takácsi-Nagy, Zoltán
Institution: University of North Carolina at Chapel Hill
Language: English
Topic: Head and Neck Cancer Studies
Subfield: Otorhinolaryngology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7203870143