Tests NBTXR3 with radiotherapy for older adults with head and neck cancer
Tests NBTXR3 with radiotherapy in older adults with advanced head and neck cancer.
Plain-language title generated from the registry record
Registry title: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Key facts
- Where
- Braga, Lisbon, Porto, and Vila Nova de Gaia, PortugalSee the 5 sites
- Phase
- Phase 3
Where in Portugal
- Uls Braga - Hosp. BragaBraga, PortugalNo longer taking part
- Hosp. Cuf DescobertasLisbon, PortugalTaking people
- Uls Santa Maria Hosp. Santa MariaLisbon, PortugalNo longer taking part
- Uls Santo Antonio - Hosp. Santo AntonioPorto, PortugalNo longer taking part
- Uls Gaia EspinhoVila Nova de Gaia, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johnson & Johnson Enterprise Innovation Inc.
- Trial code
- NCT04892173EU 2024-520386-31-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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 Locally Advanced Head & Neck Squamous Cell Carcinoma
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: 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: 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; Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC; Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin.