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NCT Number: NCT07219212

A Study of JNJ-90301900 in Combination With 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).

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Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hopital De La Cavale Blanche, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

JNJ-90301900

Drug

JNJ-90301900 will administered via intratumoral and/or intranodal injection.

Other names: NBTXR3, Functionalized hafnium oxide nanoparticles

Cisplatin

Drug

Cisplatin will be administered intravenously.

Intensity Modulated Radiation Therapy (IMRT)

Radiation

IMRT radiation therapy will be administered.

carboplatin

Drug

Carboplatin will be administered intravenously.

paclitaxel

Drug

Paclitaxel will be administered intravenously.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complete Response (CR) Rate

    Time frame: Up to approximately 2 years 14 weeks

    Percentage of participants achieving CR according to RECIST v.1.1 will be reported.

  2. Objective Response Rate (ORR) According to RECIST v.1.1

    Time frame: Up to approximately 2 years 14 weeks

    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.

  3. Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years 14 weeks

    DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.

  4. Injected Tumor Response Rate

    Time frame: Up to approximately 2 years 14 weeks

    Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.

  5. Time to Locoregional Failure (LRF)

    Time frame: Up to approximately 2 years 14 weeks

    Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.

  6. Time to Distant Failure (DF)

    Time frame: Up to approximately 2 years 14 weeks

    Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.

  7. Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years 14 weeks

    PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.

  8. Number of Participants with Post-Radiation Neck Dissection (PRND)

    Time frame: Up to approximately 2 years 14 weeks

    Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.

  9. Number of Participants with Post-Radiation Primary Surgery

    Time frame: Up to approximately 2 years 14 weeks

    Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Acronym: LUMIRAY

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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