An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Trial Status: active
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).
Inclusion Criteria
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 Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT04892173.
