Status:
RECRUITING
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Lead Sponsor:
Johnson & Johnson Enterprise Innovation Inc.
Conditions:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Aged
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Participants will undergo a screening assessment over a period of less than or equal to (\<=) 28 days to determine eligibility. Eligible participants will be treated by the Investigator's choice of R...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04892173
Start Date
December 10 2021
End Date
June 30 2028
Last Update
December 5 2025
Active Locations (186)
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1
City of Hope
Duarte, California, United States, 91010
2
Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, United States, 92653
3
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
4
Hoag Memorial Hospital
Newport Beach, California, United States, 92663