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

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).

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Drug: JNJ-90301900; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • Hôpital de la Cavale blanche
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambret
  • Marseille, France, 13385
    • Recruiting
    • Hôpital La Timone
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
• Japan
  • Hiroshima, Japan, 734 8551
    • Recruiting
    • Hiroshima University Hospital
  • Nagoya, Japan, 464-8681
    • Recruiting
    • Aichi Cancer Center
  • Tokyo, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffit Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
  • New York
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 cisplatin chemotherapy
• Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT); Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin 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.

Drug: JNJ-90301900; JNJ-90301900 will administered via intratumoral and/or intranodal injection.; Other Names: NBTXR3; Functionalized hafnium oxide nanoparticles; Drug: Cisplatin; Cisplatin will be administered intravenously.; Radiation: Intensity Modulated Radiation Therapy (IMRT); IMRT radiation therapy will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 2 years 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 2 years 14 weeks
Complete Response (CR) Rate	Percentage of participants achieving CR according to RECIST v.1.1 will be reported.	Up to approximately 2 years 12 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.	Up to approximately 2 years 12 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.	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.	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.	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.	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.	Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Primary Salvage Surgery	Participants with post-radiation primary salvage surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.	Up to approximately 2 years 14 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): July 14, 2028
• Study Completion (Estimated): July 14, 2028

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 17, 2025
• First Posted (Actual): October 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Therapeutics; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Cisplatin; Radiotherapy, Intensity-Modulated
• Other Study ID Numbers: 90301900HNC1001 (Other Identifier: Janssen Research & Development, LLC); 2025-522914-22-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No