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.Clinical trial registration https://clinicaltrials.gov identifier is NCT04892173; EudraCT Number: 2021-002163-22.
Source: Future Oncology
Authors: Christophe Le Tourneau, Zoltán Takácsi-Nagy, Sandra Nuyts, Sébastien Thureau, Feng Liu, Caroline Hoffmann, Trevor G. Hackman, Maria Lesnik, Anaïs Debard, Laetitia Finzi, Kiran Devisetty, Omar I. Vivar, Leonard A. Farber, France Nguyen, Xavier Liem, Eteri Natelauri, Amanda Psyrri, Martin Burian, Jinming Yu, Sue S. Yom
Institutions: Institut Curie, Semmelweis University, Laboratoire d'Informatique, du Traitement de l'Information et des Systèmes, Université de Rouen Normandie, Hunan Cancer Hospital, University of North Carolina at Chapel Hill, Nanobiotix (France), Johnson & Johnson (United States), Institut Gustave Roussy, Fondation Gustave Roussy, Centre Oscar Lambret, National and Kapodistrian University of Athens, University General Hospital Attikon, Ordensklinikum Linz Barmherzige Schwestern, University of California, San Francisco
Language: English
Topic: Head and Neck Cancer Studies
Subfield: Otorhinolaryngology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4410092458