JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Recruiting
Phase 3Interventional Study
Carcinoma, Squamous Cell
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Johnson & Johnson Enterprise Innovation Inc. · Industry
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
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…
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):
1. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
2. Grade \>= 2 hearing loss or tinnitus,
3. Grade \>= 2 peripheral neuropathy,
4. New York Heart Association Class 3
5. 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
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