Squamous Cell Carcinoma of Head and NeckPhase 1LUMIRAYNCT07219212
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study testing JNJ-90301900, Cisplatin and Intensity Modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Head and Neck, run by Johnson & Johnson Enterprise Innovation Inc. at 25 sites in 4 countries.
Trial summary
This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- JNJ-90301900, Cisplatin and Intensity Modulated Radiation Therapy (IMRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 26 Jan 2026to 14 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
- Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
- A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
- Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Who cannot join
- Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
- Non-squamous histology
- Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
- Ineligible to receive platinum-based chemotherapy
- Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
Trial locations and contacts
25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 4 countries
United States10 sites, 9 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Suspended
University of California at San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Moffit Cancer center
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
France6 sites, 6 recruiting
- Recruiting
Hopital De La Cavale Blanche
Brest, 29200
- Recruiting
CHU de Grenoble
La Tronche, 38700
- Recruiting
Centre Oscar Lambret
Lille, 59000
- Recruiting
Hopital La Timone
Marseille, 13385
- Recruiting
Centre Henri Becquerel
Rouen, 76038
- Recruiting
Gustave Roussy
Villejuif, 94805
Japan5 sites, 5 recruiting
- Recruiting
Hiroshima University Hospital
Hiroshima, 734 8551
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277 8577
- Recruiting
Aichi Cancer Center
Nagoya, 464-8681
- Recruiting
Shizuoka Cancer Center
Shizuoka, 411 8777
- Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
Spain4 sites, 4 recruiting
- Recruiting
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
- Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28009
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
About this study
Official title: A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- JNJ-90301900, Cisplatin, Intensity Modulated Radiation Therapy (IMRT), Carboplatin, Paclitaxel
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-90301900Drug
Also called NBTXR3, Functionalized hafnium oxide nanoparticles
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
CisplatinDrug
Cisplatin will be administered intravenously.
Intensity Modulated Radiation Therapy (IMRT)Radiation
IMRT radiation therapy will be administered.
CarboplatinDrug
Carboplatin will be administered intravenously.
PaclitaxelDrug
Paclitaxel will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) | Experimental | Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first. Receives: Drug: JNJ-90301900; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.
Measured: Up to approximately 2 years 14 weeks
Secondary outcomes (9)
Complete Response (CR) Rate
Percentage of participants achieving CR according to RECIST v.1.1 will be reported.
Measured: Up to approximately 2 years 14 weeks
Objective Response Rate (ORR) According to RECIST v.1.1
ORR defined as percentage of participants achieving complete response (CR) or partial response (PR) by investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Measured: Up to approximately 2 years 14 weeks
Disease Control Rate (DCR)
DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.
Measured: Up to approximately 2 years 14 weeks
Injected Tumor Response Rate
Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.
Measured: Up to approximately 2 years 14 weeks
Time to Locoregional Failure (LRF)
Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.
Measured: Up to approximately 2 years 14 weeks
Time to Distant Failure (DF)
Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.
Measured: Up to approximately 2 years 14 weeks
Progression Free Survival (PFS)
PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Neck Dissection (PRND)
Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Measured: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Primary Surgery
Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Measured: Up to approximately 2 years 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start26 Jan 2026
- Primary completion14 Jul 2028 (estimated)
- Study completion14 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial, Study director, Johnson & Johnson Enterprise Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219212
- Sponsor's protocol ID
- 90301900HNC1001
- Other IDs
- 2025-522914-22-00, 2025
- Acronym
- LUMIRAY
- Status last verified
- Nov 2026
- First submitted
- 17 Oct 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07219212
- Acronym / sponsor ID
- LUMIRAY / 90301900HNC1001
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 14 Jul 2028 (estimated)
- Study completion
- 14 Jul 2028 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) | Experimental | Drug: JNJ-90301900, Drug: Cisplatin, Radiation: Intensity Modulated Radiation Therapy (IMRT), Drug: Carboplatin, Drug: PaclitaxelParticipants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
- Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
- A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
- Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Key exclusion criteria (5 listed)
- Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
- Non-squamous histology
- Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
- Ineligible to receive platinum-based chemotherapy
- Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-90301900Also: NBTXR3, Functionalized hafnium oxide nanoparticlesJNJ-90301900 will administered via intratumoral and/or intranodal injection. | Drug | JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
| CisplatinCisplatin will be administered intravenously. | Drug | JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
| Intensity Modulated Radiation Therapy (IMRT)IMRT radiation therapy will be administered. | Radiation | JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
| CarboplatinCarboplatin will be administered intravenously. | Drug | JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
| PaclitaxelPaclitaxel will be administered intravenously. | Drug | JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) |
Primary outcome
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to approximately 2 years 14 weeks
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.
9 secondary outcomes
Complete Response (CR) Rate
Time frame: Up to approximately 2 years 14 weeks
Objective Response Rate (ORR) According to RECIST v.1.1
Time frame: Up to approximately 2 years 14 weeks
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years 14 weeks
Injected Tumor Response Rate
Time frame: Up to approximately 2 years 14 weeks
Time to Locoregional Failure (LRF)
Time frame: Up to approximately 2 years 14 weeks
Time to Distant Failure (DF)
Time frame: Up to approximately 2 years 14 weeks
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Neck Dissection (PRND)
Time frame: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Primary Surgery
Time frame: Up to approximately 2 years 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial study director
Johnson & Johnson Enterprise Innovation Inc.
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-90301900, Cisplatin and Intensity Modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Head and Neck, run by Johnson & Johnson Enterprise Innovation Inc. at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, France, Japan, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) by Severity (time frame: Up to approximately 2 years 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.