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

Johnson & Johnson (J&J)

Status and phase: Enrolling; Phase 1

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: JNJ-90301900

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219212

90301900HNC1001

2025-522914-22-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-90301900

Radiation: Intensity Modulated Radiation Therapy (IMRT)

Drug: Cisplatin