A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
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):
Eastern cooperative oncology group (ECOG) performance status 0 to 1
Life expectancy >= 6 months
Exclusion Criteria:
Participate-In-This-Study1@its.jnj.com844-434-4210
La Jolla, California 92093, United States
Laguna Hills, California 92653, United States
Washington D.C., District of Columbia 20052, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27514, United States
Philadelphia, Pennsylvania 19104, United States
Norfolk, Virginia 23507, United States
São Paulo, 01246 000, Brazil
Vitória, 29043 260, Brazil
Guangzhou, 510080, China
Nanjing, 223800, China
Wuhan, 430022, China
Wuhan, 430030, China
Tbilisi, 144, Georgia
Athens, 124 62, Greece
Thessaloniki, 54639, Greece
Osaka Sayama Shi, 589 8511, Japan
Sunto Gun, 411 8777, Japan
L'Hospitalet de Llobregat, 08908, Spain
Las Palmas de Gran Canaria, 35001, Spain
Bei Qu, 704, Taiwan
Newcastle upon Tyne, NE7 7DN, United Kingdom