Treatment for elderly patients with advanced head and neck cancer using a new drug and radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, open-label, randomized Phase 3 study aims to evaluate the efficacy and safety of JNJ-90301900 (NBTXR3) in combination with radiation therapy, with or without cetuximab, in treatment-naïve, platinum-ineligible elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Participants will be screened for eligibility and then randomized into two arms: one receiving NBTXR3 with radiation and the other receiving radiation alone or with cetuximab. The treatment will involve a total radiation dose of 70 Gy over 35 fractions, followed by regular follow-up visits for up to two years. The study seeks to determine the potential benefits of this novel approach in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age greater than or equal to (\>=) 60 years old
* Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
* Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
* One primary tumor lesion amendable for intratumoral injection
* Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):

  1. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
  2. Grade \>= 2 hearing loss or tinnitus,
  3. Grade \>= 2 peripheral neuropathy,
  4. New York Heart Association Class 3
  5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14 or Aged \>= 75 years old
* Eastern cooperative oncology group (ECOG) performance status 0 to 1
* Life expectancy \>= 6 months

Exclusion Criteria:

* Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
* Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
* Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
* Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
* Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• University of California at San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• UCLA Hematology Oncology
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• George Washington University Cancer Center
  Washington D.C., District of Columbia, United States Recruiting

+146 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zanzalintinib with pembrolizumab and cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial tests whether adding the oral drug zanzalintinib to pembrolizumab and cetuximab is safe and finds the best dose for adults with recurrent or metastatic head and neck squamous cell cancer.

  Recruiting Phase 1 University of Chicago · Chicago, Illinois · NCT06912087

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• Cetuximab bioequivalence test in healthy men

  This study tests whether a cetuximab injection is bioequivalent to Erbitux in healthy men to see if they behave the same in the body.

  Recruiting Phase 1 HC Biopharma Inc. · Haikou, Hainan · NCT07813468

• HSK42360-Na tablets with cetuximab in BRAF V600-mutant metastatic colorectal cancer

  This Phase 1/2 study tests whether HSK42360-Na tablets with cetuximab, with or without standard chemotherapy, are safe and may help people whose colorectal cancer has a BRAF V600 mutation that has spread.

  Recruiting Phase 1/2 Haisco Pharmaceutical Group Co., Ltd. · Beijing · NCT07790510

• Neoadjuvant therapy with encorafenib plus cetuximab N01 and mFOLFOX6 in locally advanced BRAF V600E-mutant colorectal cancer

  This trial tests a targeted, pre-surgery treatment to see if it improves the chance of long-term control in adults with locally advanced BRAF V600E-mutant colorectal cancer.

  Recruiting Phase 2 Zhejiang University · Hangzhou, Zhejiang · NCT07789210

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.