Comparing JNJ-90301900 with Cetuximab for squamous cell carcinoma
Official title: JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
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
- Phase 3
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
JNJ-90301900 (NBTXR3)
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
- Medication
Cetuximab
Solution for infusion
- Radiation therapy
Radiation Therapy
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- +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
- +Age greater than or equal to (\>=) 60 years old
- +One primary tumor lesion amendable for intratumoral injection
- +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
- +Life expectancy \>= 6 months
- +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
- +Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
Exclusion
- −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
- −Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives JNJ-90301900 (NBTXR3), together with one or more of: Cetuximab and Radiation Therapy.
Registry label: A: Arm A: JNJ-90301900 (NBTXR3)
Group B, the comparison group, receives Cetuximab, together with one or more of: Radiation Therapy.
Registry label: B: Arm B: RT alone or RT in combination with cetuximab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 60 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 500 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: 30 months following first randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → participant.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free Survival (PFS) Based on Independent Central Review (ICR) — measured over 30 months following first randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → participant.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04892173 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About JNJ-90301900 (NBTXR3)Drug
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CetuximabDrug
Solution for infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Radiation TherapyRadiation
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 60 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 60 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 months following first randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → participant.
The study as a whole is currently expected to finish around 2028-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Toronto, Ontario, Canada; New York, New York, United States; Staten Island, New York, United States; The Bronx, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (3)
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.