Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Johnson & Johnson Enterprise Innovation Inc. (Voir sur ClinicalTrials)
janvier 2022
décembre 2027
02 octobre 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:12 | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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):
1. 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
2. Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14
3. 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