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A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

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Trial Profile

A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2025

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At a glance

  • Drugs Hafnium oxide (Primary) ; Cetuximab; Ropidoxuridine
  • Indications Head and neck cancer; Hypopharyngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NANORAY-312
  • Sponsors Janssen; Johnson & Johnson Innovation; Nanobiotix

Most Recent Events

  • 02 Apr 2025 According to a Nanobiotix media release, the company completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025.
  • 02 Apr 2025 According to a Nanobiotix media release, the company aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company (Johnson & Johnson) in 2Q2024 to begin preparations for interim analysis.
  • 17 Mar 2025 According to a Nanobiotix media release, company amendment removes Nanobiotix's funding obligation for NANORAY-312 and releases Johnson & Johnson from select future potential milestone payments, while safeguarding Nanobiotix's path to sustainable cashflow through significant potential milestone payments.

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