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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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04892173.
