UPCC 05326 A Study of JNJ-90301900 in Combination with Concurrent Chemoradiation Therapy in Participants with Locally Advanced Head and Neck Squamous Cell Carcinoma (LUMIRAY)

Study of Investigational Medication with Combined Chemotherapy and Radiation Therapy for Head and Neck Squamous Cell Carcinoma

Enrolling By Invitation
18 years - 74 years
All
Phase 1
45 participants needed
1 Location

Brief description of study

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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Squamous Cell Carcinoma of Head and Neck
  • Age: 18 years - 74 years
  • Gender: All

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

This study investigates head and neck squamous cell carcinoma. The purpose of this study is to evaluate the safety and effectiveness of an investigational medication when used with standard chemotherapy and radiation therapy.

The study focuses on assessing how well the investigational medication works with chemoradiation therapy. It evaluates the treatment's safety and effectiveness in a general way.

  • Who can participate: Adults with a confirmed diagnosis of head and neck squamous cell carcinoma at stage III, IVA, or IVB, eligible for chemoradiation therapy, and with a performance status of 0 or 1 can participate.
  • Study details: Participants will receive the investigational medication injected into tumors along with standard chemotherapy and radiation therapy. A placebo is not used in this study.
Updated on 02 Jul 2026. Study ID: 26-6129
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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