A Phase 3 interventional study of JNJ-90301900 (NBTXR3) and Cetuximab in Carcinoma, Squamous Cell, sponsored by Johnson & Johnson Enterprise Innovation Inc.. Recruiting at 196 sites in 27 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johnson & Johnson Enterprise Innovation Inc. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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).
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 500 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Johnson & Johnson Enterprise Innovation Inc. is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Carcinoma, Squamous Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
Drug: JNJ-90301900 (NBTXR3) · Drug: Cetuximab · Radiation: Radiation Therapy
Investigator's choice of RT alone or RT in combination with cetuximab.
Drug: Cetuximab · Radiation: Radiation Therapy
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Also known as: Functionalized hafnium oxide nanoparticles, NBTXR3
Solution for infusion
Also known as: Erbitux
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
Time frame: 30 months following first randomized participant
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: 48 months following first randomized participant
Local-regional control
Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Distant control
Time to distant progression: time from randomization to distant progression or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Quality of Life over time - QLQ H&N35
Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H\&N35).
Time frame: 48 months following first randomized participant
Quality of Life over time - EQ 5D 5L
Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.
Time frame: 48 months following first randomized participant
Safety across duration of study - AEs
Adverse events (AEs).
Time frame: 48 months following first randomized participant
Objective Response Rate (ORR)
Rate of complete response (CR)+partial response (PR) \[RESIST 1.1\].
Time frame: 48 months following first randomized participant
Duration of Overall Response
Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.
Time frame: 48 months following first randomized participant
Head and Neck Cancer Specific Event-Free Survival
Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first.
Time frame: 48 months following first randomized participant
Head and Neck Cancer-Specific Survival
Time from randomization to head and neck cancer-related death.
Time frame: 48 months following first randomized participant
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 196 sites across 27 countries. Choose a country and city above to see the rest.
Plan to share: No
Started Dec 2021 (actual). Primary completion is estimated for Jun 2028, 78 months after the start.
Of 78 phase 3 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 117. This study's planned 78 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hafnium oxide
Squamous Cell Carcinoma of Head and Neck →
Johnson & Johnson Enterprise Innovation Inc. →