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JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

NCT04892173 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Conditions

  • Carcinoma, Squamous Cell

Interventions

DRUG

JNJ-90301900 (NBTXR3)

Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.

DRUG

Cetuximab

Solution for infusion

RADIATION

Radiation Therapy

Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Sponsors & Collaborators

  • Johnson & Johnson Enterprise Innovation Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Enterprise Innovation Inc Clinical trial · Johnson & Johnson Enterprise Innovation Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • Czechia
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Japan
  • Philippines
  • Portugal
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892173 on ClinicalTrials.gov