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. 2025 May;21(12):1489-1499.
doi: 10.1080/14796694.2025.2496131. Epub 2025 May 5.

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

Christophe Le Tourneau  1 , Zoltán Takácsi-Nagy  2 , Sandra Nuyts  3 , Sébastien Thureau  4 , Feng Liu  5 , Caroline Hoffmann  1 , Trevor G Hackman  6 , Maria Lesnik  1 , Anaïs Debard  7 , Laetitia Finzi  7 , Kiran Devisetty  8 , Omar I Vivar  7 , Leonard A Farber  7 , France Nguyen  9 , Xavier Liem  10 , Eteri Natelauri  11 , Amanda Psyrri  12 , Martin Burian  13 , Jinming Yu  14 , Sue S Yom  15
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Nanoray-312: phase III study of NBTXR3 + radiotherapy ± cetuximab in elderly, platinum-ineligible locally advanced HNSCC

Christophe Le Tourneau et al. Future Oncol. 2025 May.

Abstract

https://clinicaltrials.gov identifier is NCT04892173; EudraCT Number: 2021-002163-22.

Keywords: H&N; LA-HNSCC; NBTXR3; cetuximab; cisplatin-ineligible; hafnium oxide nanoparticles; radioenhancer; radiotherapy.

Plain language summary

Locally advanced head and neck cancer is a type of cancer that starts in the tissues of the head or neck region and has spread to nearby areas. Older patients with this cancer often have other health problems or may be frail, which can make it harder for them to tolerate the usual treatment of cisplatin (an anti-cancer drug) combined with radiation. This can make it difficult for some older patients to receive the standard treatment, so there is a need for other treatment options.NBTXR3 is a new type of treatment that helps improve how radiation therapy works. It is a special kind of nanoparticle that is injected into cancer cells. When radiation is given, these nanoparticles help the radiation kill more cancer cells and slow down cancer growth. Research suggests NBTXR3 also helps the immune system recognize and attack cancer cells more effectively and that NBTXR3 can make cancer treatment more effective, with better results for patients.NANORAY-312 is a study looking at how NBTXR3 works when used with radiation (and some patients may also receive cetuximab, a drug that helps the immune system fight cancer) in treating older patients with locally advanced head and neck cancer. The study is testing whether this treatment can be a good alternative for those who cannot receive cisplatin. The study is ongoing, and its main goal is to see whether patients who receive NBTXR3 will live longer than those who will not receive the treatment.

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Conflict of interest statement

Christophe Le Tourneau has received honoraria from Bristol-Myers Squibb; Celgene; GlaxoSmithKline; Merck Serono; MSD; Nanobiotix; Novartis; Rakuten Medical; Roche; and has received consulting fees from or has been an advisory board member of Amgen; AstraZeneca; AstraZeneca; Bristol-Myers Squibb; GlaxoSmithKline; Merck Serono; MSD; Nanobiotix; Roche; and has received payment for travel/accommodations/expenses from AstraZeneca; Bristol-Myers Squibb; and MSD. Zoltán Takácsi-Nagy has received honoraria from Nanobiotix. Sandra Nuyts has received honoraria from Merck Serono; MSD. Sébastien Thureau has no relationships to disclose. Feng Liu has no relationships to disclose. Caroline Hoffmann has received honoraria from Nanobiotix, has received research funding from Merck KGaA, is currently employed at and has stock from Owkin. Trevor Hackman no conflicts or relationships to disclose. Maria Lesnik hasn’t received any honoraria nor fundings and has no relationship to disclose. Anaïs Debard, Laetitia Finzi, Omar I Vivar, and Leonard A Farber are employed by Nanobiotix. Kiran Devisetty is employed by Johnson & Johnson. France Nguyen has no relationships to disclose. Xavier Liem has no relationships to disclose. Eteri Natelauri has no relationships to disclose. Amanda Psyrri has no relationships to disclose. Martin Burian has no relationships to disclose. Jinming Yu has no relationships to disclose. Sue S. Yom has received research grants from Bristol Myers Squibb and EMD Serono and royalties from Springer and UpToDate. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing assistance was provided by Bingham Mayne and Smith and funded by Nanobiotix SA.

Figures

Figure 1.
Figure 1.
NANORAY-312 planned global participation.
See this image and copyright information in PMC

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