Recruiting NCT04892173

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

Phase III Interventional Carcinoma, Squamous Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: JNJ-90301900 (NBTXR3), Cetuximab, Radiation Therapy.
Who it may be relevant to: Registry conditions: Carcinoma, Squamous Cell. Basic parameters: from 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Austria, Belgium, Brazil, Bulgaria +22
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Primary outcome measures

Progression-free Survival (PFS) Based on Independent Central Review (ICR) [Time frame: 30 months following first randomized participant]

Secondary outcome measures (10)

Overall Survival (OS) [Time frame: 48 months following first randomized participant]
Local-regional control [Time frame: 48 months following first randomized participant]
Distant control [Time frame: 48 months following first randomized participant]
Quality of Life over time - QLQ H&N35 [Time frame: 48 months following first randomized participant]
Quality of Life over time - EQ 5D 5L [Time frame: 48 months following first randomized participant]
Safety across duration of study - AEs [Time frame: 48 months following first randomized participant]
Objective Response Rate (ORR) [Time frame: 48 months following first randomized participant]
Duration of Overall Response [Time frame: 48 months following first randomized participant]
Head and Neck Cancer Specific Event-Free Survival [Time frame: 48 months following first randomized participant]
Head and Neck Cancer-Specific Survival [Time frame: 48 months following first randomized participant]

Eligibility criteria

Inclusion criteria

Age greater than or equal to (>=) 60 years old
Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
One primary tumor lesion amendable for intratumoral injection
Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):

Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
Grade >= 2 hearing loss or tinnitus,
Grade >= 2 peripheral neuropathy,
New York Heart Association Class 3
Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14 or Aged >= 75 years old
Eastern cooperative oncology group (ECOG) performance status 0 to 1
Life expectancy >= 6 months

Exclusion criteria

Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 35 centers

The Affiliated Hospital of Bengbu Medical College — Bengbu
Xiangya Hospital Central South University — Changsha
Hunan Cancer hospital — Changsha
Sichuan Cancer Hospital — Chengdu
Dongguan People s Hospital — Dongguan
Fujian Medical University Union Hospital — Fuzhou
The First Affiliated Hospital of Fujian Medical University — Fuzhou
Fujian Medical University Fujian Provincial Cancer Hospital — Fuzhou
… and 27 more centers

United States · 26 centers

University of Alabama at Birmingham — Birmingham
City of Hope — Duarte
University of California at San Diego Moores Cancer Center — La Jolla
Memorial Radiation Oncology Medical Group Laguna Hills — Laguna Hills
UCLA Hematology Oncology — Los Angeles
Hoag Memorial Hospital — Newport Beach
University of California San Francisco — San Francisco
George Washington University Cancer Center — Washington D.C.
… and 18 more centers

France · 18 centers