CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 500 target
Drug / intervention
JNJ-90301900 (NBTXR3) +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age ≥60 years old
  • ✓Biopsy-confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or supraglottic larynx candidate for definitive radiation therapy with or without cetuximab
  • ✓Clinical stage T3-4 NX or T2 N2-3 disease (8th edition AJCC)
  • ✓One primary tumor lesion amendable for intratumoral injection
Key exclusion· 5
  • ✕Carcinoma of nasopharynx, paranasal sinus, salivary gland, thyroid gland; non-squamous histology; or SCC of unknown primary origin
  • ✕Clinical stage T1-2 N0, T2 N1, or M1 disease (8th edition AJCC)
  • ✕Loco-regionally recurrent head & neck cancer previously treated with surgery, radiation, and/or chemotherapy
  • ✕Prior or concurrent primary malignancy within 2 years of informed consent with potential to interfere with safety/efficacy assessment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04892173
NCT04892173Phase 3RecruitingOn Track
Long Recruiting
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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 Locally Advanced Head & Neck Squamous Cell Carcinoma

Johnson & Johnson Enterprise Innovation Inc.·interventional·Posted May 19, 2021·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating JNJ-90301900 (NBTXR3), Cetuximab, and 1 other intervention for Carcinoma, Squamous Cell. Currently recruiting, targeting 500 participants across 191 sites in 27 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell
CountriesAustria, 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, United States
Collaborators--

Timeline

Phase 3Recruiting
2022202320242025202620272028
First PostedMay 19, 2021
Enrollment StartDec 10, 2021
Primary CompletionJun 30, 2028
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 5.1 years agoPrimary completion in 2.0 years

Arms & Interventions

Arm A: JNJ-90301900 (NBTXR3)experimental

JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.

Drug: JNJ-90301900 (NBTXR3)Drug: CetuximabRadiation: Radiation Therapy
Arm B: RT alone or RT in combination with cetuximabactive_comparator

Investigator's choice of RT alone or RT in combination with cetuximab.

Drug: CetuximabRadiation: Radiation Therapy

Interventions

JNJ-90301900 (NBTXR3)drug

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

Cetuximabdrug

Solution for infusion

Radiation Therapyradiation

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