JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
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
Johnson & Johnson Enterprise Innovation Inc.
500 participants
Dec 10, 2021
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria8
- Age greater than or equal to (\>=) 60 years old
- 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, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
- Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14
- Age \>= 75 years old
Exclusion Criteria6
- Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
- Non-squamous cell histology
- 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
Interventions
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Solution for infusion
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Locations(189)
View Full Details on ClinicalTrials.gov
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NCT04892173