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JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2021-12-10
Completion Date
2028-06-30
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
JNJ-90301900 (NBTXR3)
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Cetuximab
Solution for infusion
Radiation Therapy
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Locations (196)
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of California at San Diego Moores Cancer Center
La Jolla, California, United States
Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, United States
UCLA Hematology Oncology
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
University of California San Francisco
San Francisco, California, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health And Science University
Portland, Oregon, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
Norfolk, Virginia, United States
Medizinische Universitat Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria
Medizinische Universitaet Wien
Vienna, Austria
Cliniques Universitaires Saint Luc
Brussels, Belgium
Grand Hopital De Charleroi Site Les Viviers
Charleroi, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Fundacao Pio XII
Barretos, Brazil
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, Brazil
Centro Regional Integrado de Oncologia CRIO
Fortaleza, Brazil
Instituto Do Cancer Do Ceara
Fortaleza, Brazil
Fundacao Sao Francisco Xavier
Ipatinga, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Hospital do Cancer de Londrina
Londrina, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Ensino e Terapia de Inovacao Clinica AMO Etica
Salvador, Brazil
Funfarme Sjrp
São José do Rio Preto, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil
MHAT Uni Hospital
Panagyurishte, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, Bulgaria
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
The Affiliated Hospital of Bengbu Medical College
Bengbu, China
Xiangya Hospital Central South University
Changsha, China
Hunan Cancer hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
Dongguan People s Hospital
Dongguan, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Fujian Medical University Fujian Provincial Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China
Guangzhou Medical University Affiliated Oncology Hospital
Guangzhou, China
Guangzhou First Municipal People's Hospital
Guangzhou, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Cancer Hospital
Jinan, China
Linyi Cancer Hospital
Linyi, China
Liuzhou people's Hospital
Liuzhou, China
Jiangxi Cancer Hospital
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Wuming Hospital of Guangxi Medical University
Nanning, China
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Liaoning Cancer Hospital and Institute
Shenyang, China
Peking University Shenzhen Hospital
Shenzhen, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Second Affiliated Hospital, SooChow University
Suzhou, China
Shanxi Provincial Cancer hospital
Taiyuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
The first affiliated hospital of xiamen university
Xiamen, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Henan Cancer Hospital
Zhengzhou, China
The Fifth Affiliated Hospital Sun Yat Sen University
Zhuhai, China
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Nemocnice Bulovka
Prague, Czechia
Tampereen Yliopistollinen Sairaala
Tampere, Finland
CHU Amiens Picardie
Amiens, France
CHU Brest
Brest, France
Centre Francois Baclesse
Caen, France
Centre Georges Francois Leclerc
Dijon, France
Centre de Lutte contre le Cancer Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Hopital de la Timone
Marseille, France
Clinique Ambroise Pare
Neuilly-sur-Seine, France
Hopital Europeen Georges Pompidou
Paris, France