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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

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: 01 Dec 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

  • 31 Oct 2025 According to a Nanobiotix media release, in Feb 2020, the USFDA granted Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the same population which is being studied in this trial.
  • 31 Oct 2025 According to a Nanobiotix media release, through the financing agreement with HealthCare Royalty, the Company expects to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) by early 2028 subject to closing of the agreement.
  • 24 Oct 2025 According to a Nanobiotix media release, Nanobiotix has completed the transfer of NANORAY-312 sponsorship, initiated in 3Q2024, in the majority of regions along with the transfer of full operational control of the Phase 3 clinical trial to Johnson & Johnson (J&J). interim data will be analyzed and reported, after both the requisite number of events have been observed and the last patient has been recruited, in 1H2027.

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