A Phase 3 (Pivotal Stage) 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 Locally Advanced Head & Neck Squamous Cell Carcinoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520386-31-00

Acronym

NANORAY-312

Enrollment

194

Registered

2025-06-25

Start date

2025-09-22

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Head & Neck Squamous Cell Carcinoma

Brief summary

Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first

Interventions

DRUGErbitux 5 mg/mL solution for infusion

DRUGJNJ-90301900

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first	—

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026