JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Start Date
12/10/2021
Completion Date
6/30/2028
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).
Eligibility Criteria
Age Range: 60 years to No maximum
Interventions
JNJ-90301900 (NBTXR3)
Cetuximab
Radiation Therapy
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
City of Hope
Duarte, California 91010
United States
University of California at San Diego Moores Cancer Center
La Jolla, California 92093
United States
Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California 92653
United States
UCLA Hematology Oncology
Los Angeles, California 90095
United States
Hoag Memorial Hospital
Newport Beach, California 92663
United States
University of California San Francisco
San Francisco, California 94158
United States
George Washington University Cancer Center
Washington D.C., District of Columbia 20052
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico 87505
United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York 10032
United States
Richmond University Medical Center
Staten Island, New York 10310
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina 28204
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health And Science University
Portland, Oregon 97239
United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
University of Virginia
Charlottesville, Virginia 22908
United States
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
Norfolk, Virginia 23507
United States
Medizinische Universitat Graz
Graz, 8036
Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010
Austria
Medizinische Universitaet Wien
Vienna, 1090
Austria
Cliniques Universitaires Saint Luc
Brussels, 1200
Belgium
Grand Hopital De Charleroi Site Les Viviers
Charleroi, 6060
Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos, 14784
Brazil
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, 30380 472
Brazil
Centro Regional Integrado de Oncologia CRIO
Fortaleza, 60336 232
Brazil
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Fortaleza, 60430-230
Brazil
Fundacao Sao Francisco Xavier
Ipatinga, 35160 158
Brazil
Hospital Amaral Carvalho
Jaú, 17210120
Brazil
Hospital do Cancer de Londrina
Londrina, 86015 520
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170
Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000
Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-200
Brazil
Grupo Oncoclinicas - Botafogo
Rio de Janeiro, 22250-905
Brazil
Ensino e Terapia de Inovacao Clinica AMO Etica
Salvador, 41950 640
Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000
Brazil
Hospital Sirio Libanes Sao Paulo
São Paulo, 01308-050
Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, 29043 260
Brazil
MHAT Uni Hospital
Panagyurishte, 4500
Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, 1756
Bulgaria
Sunnybrook Health Sciences Center
Toronto, Ontario M4N 3M5
Canada
The Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
China
Xiangya Hospital Central South University
Changsha, 410008
China
Hunan Cancer hospital
Changsha, 410013
China
Sichuan Cancer Hospital
Chengdu, 610041
China
Dongguan People s Hospital
Dongguan, 523109
China
Fujian Medical University Union Hospital
Fuzhou, 350001
China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005
China
Fujian Medical University Fujian Provincial Cancer Hospital
Fuzhou, 350014
China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, 510080
China
Guangzhou Medical University Affiliated Oncology Hospital
Guangzhou, 510095
China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180
China
Qilu Hospital of Shandong University
Jinan, 250012
China
Shandong Cancer Hospital
Jinan, 250117
China
Linyi Cancer Hospital
Linyi, 276002
China
Liuzhou people's Hospital
Liuzhou, 545006
China
Jiangxi Cancer Hospital
Nanchang, 330029
China
Jiangsu Cancer Hospital
Nanjing, 210009
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 223800
China
Wuming Hospital of Guangxi Medical University
Nanning, 530000
China
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, 530021
China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003
China
Fudan University Shanghai Cancer Center
Shanghai, 200032
China
Liaoning Cancer Hospital and Institute
Shenyang, 110042
China
Peking University Shenzhen Hospital
Shenzhen, 518036
China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 50011
China
Second Affiliated Hospital, SooChow University
Suzhou, 215004
China
Shanxi Provincial Cancer hospital
Taiyuan, 30013
China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
China
Hubei Cancer Hospital
Wuhan, 430079
China
The first affiliated hospital of xiamen university
Xiamen, 361003
China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221000
China
Henan Cancer Hospital
Zhengzhou, 450008
China
The Fifth Affiliated Hospital Sun Yat Sen University
Zhuhai, 519000
China
Klinicki bolnicki centar Zagreb
Zagreb, 10000
Croatia
Fakultni nemocnice Olomouc
Olomouc, 779 00
Czechia
Nemocnice Bulovka
Prague, 180 81
Czechia
Tampereen Yliopistollinen Sairaala
Tampere, 33520
Finland
CHU Amiens Picardie
Amiens, 80000
France
CHU Brest
Brest, 29609
France
Centre Francois Baclesse
Caen, 14076
France
Centre Georges Francois Leclerc
Dijon, 21000
France
Centre de Lutte contre le Cancer Centre Oscar Lambret
Lille, 59020
France
Centre Leon Berard
Lyon, 69008
France
Hopital de la Timone
Marseille, 13385
France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200
France
Hopital Europeen Georges Pompidou
Paris, 75015
France
Institut Curie
Paris, 75248
France
Hopital Tenon
Paris, 75970
France
Hopital Haut Leveque
Pessac, 33604
France
Hopital Pontchaillou
Rennes, 35000
France
CLCC - Centre Henri Becquerel
Rouen, 76038
France
CHU Saint Etienne
Saint-Etienne, 42055
France
Centre Hospitalier de Valenciennes Hopital Jean Bernard
Valenciennes, 59322
France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500
France
Gustave Roussy
Villejuif, 94805
France
High Technology Hospital MedCenter Ltd Batumi
Batumi, 6000
Georgia
JSC Vian Kutaisi Referral Hospital
Kutaisi, 4600
Georgia
Todua Clinic
Tbilisi, 0112
Georgia
Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 144
Georgia
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, 35392
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Universitatsklinikum Jena
Jena, 07747
Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, 81675
Germany
Universitaetsmedizin Rostock
Rostock, 18059
Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, 124 62
Greece
University Hospital Of Larissa
Larissa, 41110
Greece
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, 54639
Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, 57001
Greece
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, 1062
Hungary
Orszagos Onkologiai Intezet
Budapest, 1122
Hungary
Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
Szeged, 6720
Hungary
M S Ramaiah Memorial Hospital
Bangalore, 560054
India
Apollo Speciality Hospital, Chennai
Chennai, 600035
India
Meenakshi Mission Hospital and Research Center
Madurai, 625107
India
Tata Memorial Hospital
Mumbai, 400012
India
HealthCare Global HCG Manavata Cancer Centre
Nashik, 422002
India
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, 110085
India
Grant Medical foundation Ruby Hall Clinic
Pune, 411 001
India
HCG cancer center
Vijayawada, 520002
India
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
Israel
Rambam Health Care Campus
Haifa, 3109601
Israel
Hadassah Medical Center
Jerusalem, 9112001
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Tokyo Medical and Dental University Hospital
Bunkyō City, 113-8519
Japan
Hiroshima University Hospital
Hiroshima, 734 8551
Japan
National Cancer Center Hospital East
Kashiwa, 277-8577
Japan
Aichi Cancer Center
Nagoya, 464-8681
Japan
Osaka International Cancer Institute
Osaka, 541 8567
Japan
Kindai University Hospital
Osaka Sayama Shi, 589 8511
Japan
Tohoku University Hospital
Sendai, 980 8574
Japan
Jichi Medical University Hospital
Shimotsuke, 329-0498
Japan
Tokyo Medical University Hospital
Shinjuku, 160 0023
Japan
Shizuoka Cancer Center
Sunto Gun, 411 8777
Japan
University of Perpetual Help Dalta Medical Center, Inc
Las Piñas, 1742
Philippines
Manila Doctors Hospital
Manila, 1000
Philippines
The Medical City
Pasig, 1600
Philippines
St. Luke's Medical Center
Quezon City, 1112
Philippines
Uls Braga - Hosp. Braga
Braga, 4710 243
Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035
Portugal
Hosp. Cuf Descobertas
Lisbon, 1998050
Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, 4099-001
Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502
Portugal
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
Bucharest, 22328
Romania
Institute of Oncology and Radiology of Serbia
Belgrade, 11000
Serbia
Vojnomedicinska Akademija
Belgrade, 11000
Serbia
Institute of Oncology of Vojvodina
Kamenitz, 21204
Serbia
University Clinical Center Kragujevac
Kragujevac, 34000
Serbia
Severance Hospital Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, 16247
South Korea
Hosp. Univ. de Cruces
Barakaldo, 48903
Spain
Hosp Clinic de Barcelona
Barcelona, 08036
Spain
Hosp Univ Vall D Hebron
Barcelona, 8035
Spain
Instituto Catalan Deoncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908
Spain
Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
Las Palmas de Gran Canaria, 35001
Spain
Hosp. Univ. Lucus Augusti
Lugo, 27003
Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041
Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050
Spain
Hosp Regional Univ de Malaga
Málaga, 29010
Spain
Hosp. de Navarra
Pamplona, 31008
Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Spain
Hosp. Virgen Del Rocio
Seville, 41013
Spain
Inst. Valenciano de Oncologia
Valencia, 46009
Spain
Hosp. Gral. Univ. Valencia
Valencia, 46014
Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009
Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345
Sweden
National Cheng Kung University Hospital
Bei Qu, 704
Taiwan
Changhua Christian Hospital
Changhua, 500
Taiwan
Chang-Gung Memorial Hospital-Keelung
Keelung, 20442
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
United Kingdom
The Royal Marsden NHS Trust
London, SW3 6JJ
United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB
United Kingdom