Actively Recruiting
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Led by Johnson & Johnson Enterprise Innovation Inc. · Updated on 2026-05-11
500
Participants Needed
191
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to (>=) 60 years old
- Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and 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 suitable for intratumoral injection
- Ineligible for platinum-based chemotherapy due to at least one of the following: creatinine clearance between 30 and less than 50 mL/min, grade >= 2 hearing loss or tinnitus, grade >= 2 peripheral neuropathy, New York Heart Association Class 3 heart disease, aged 70-74 years with Geriatric 8 score <= 14, or aged >= 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Life expectancy of at least 6 months
You will not qualify if you...
- Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; non-squamous histology or squamous cell carcinoma 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 and neck cancer previously treated with surgery, radiation, and/or chemotherapy
- Prior or concurrent primary malignancy within the last 2 years that may interfere with safety or efficacy assessment
- Ongoing or active infection requiring antimicrobial therapy within 2 weeks of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 191 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California at San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
4
Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, United States, 92653
Completed
5
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
6
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Completed
7
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
8
George Washington University Cancer Center
Washington D.C., District of Columbia, United States, 20052
Actively Recruiting
9
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
11
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
12
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
13
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
14
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
15
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
Completed
16
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032
Completed
17
Richmond University Medical Center
Staten Island, New York, United States, 10310
Actively Recruiting
18
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
19
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
20
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
21
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
22
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
23
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
24
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
26
Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
Norfolk, Virginia, United States, 23507
Actively Recruiting
27
Medizinische Universitat Graz
Graz, Austria, 8036
Completed
28
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria, 4010
Actively Recruiting
29
Medizinische Universitaet Wien
Vienna, Austria, 1090
Actively Recruiting
30
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
31
Grand Hopital De Charleroi Site Les Viviers
Charleroi, Belgium, 6060
Actively Recruiting
32
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
33
Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos, Brazil, 14784
Actively Recruiting
34
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, Brazil, 30380 472
Actively Recruiting
35
Centro Regional Integrado de Oncologia CRIO
Fortaleza, Brazil, 60336 232
Actively Recruiting
36
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Fortaleza, Brazil, 60430-230
Actively Recruiting
37
Fundacao Sao Francisco Xavier
Ipatinga, Brazil, 35160 158
Actively Recruiting
38
Hospital Amaral Carvalho
Jaú, Brazil, 17210120
Actively Recruiting
39
Hospital do Cancer de Londrina
Londrina, Brazil, 86015 520
Actively Recruiting
40
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Actively Recruiting
41
Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil, 90610-000
Actively Recruiting
42
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil, 91350-200
Completed
43
Grupo Oncoclinicas - Botafogo
Rio de Janeiro, Brazil, 22250-905
Actively Recruiting
44
Ensino e Terapia de Inovacao Clinica AMO Etica
Salvador, Brazil, 41950 640
Actively Recruiting
45
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
46
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246 000
Actively Recruiting
47
Hospital Sirio Libanes Sao Paulo
São Paulo, Brazil, 01308-050
Actively Recruiting
48
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil, 29043 260
Actively Recruiting
49
MHAT Uni Hospital
Panagyurishte, Bulgaria, 4500
Completed
50
Specialized Hospital for Active Treatment in Oncology
Sofia, Bulgaria, 1756
Completed
51
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
52
The Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233004
Completed
53
Xiangya Hospital Central South University
Changsha, China, 410008
Completed
54
Hunan Cancer hospital
Changsha, China, 410013
Actively Recruiting
55
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
56
Dongguan People s Hospital
Dongguan, China, 523109
Actively Recruiting
57
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Completed
58
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China, 350005
Actively Recruiting
59
Fujian Medical University Fujian Provincial Cancer Hospital
Fuzhou, China, 350014
Actively Recruiting
60
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China, 510080
Actively Recruiting
61
Guangzhou Medical University Affiliated Oncology Hospital
Guangzhou, China, 510095
Actively Recruiting
62
Guangzhou First Municipal People's Hospital
Guangzhou, China, 510180
Actively Recruiting
63
Qilu Hospital of Shandong University
Jinan, China, 250012
Actively Recruiting
64
Shandong Cancer Hospital
Jinan, China, 250117
Actively Recruiting
65
Linyi Cancer Hospital
Linyi, China, 276002
Actively Recruiting
66
Liuzhou people's Hospital
Liuzhou, China, 545006
Actively Recruiting
67
Jiangxi Cancer Hospital
Nanchang, China, 330029
Completed
68
Jiangsu Cancer Hospital
Nanjing, China, 210009
Completed
69
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China, 223800
Actively Recruiting
70
Wuming Hospital of Guangxi Medical University
Nanning, China, 530000
Actively Recruiting
71
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China, 530021
Actively Recruiting
72
The Affiliated Hospital of Medical College Qingdao University
Qingdao, China, 266003
Actively Recruiting
73
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Completed
74
Liaoning Cancer Hospital and Institute
Shenyang, China, 110042
Completed
75
Peking University Shenzhen Hospital
Shenzhen, China, 518036
Actively Recruiting
76
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China, 50011
Actively Recruiting
77
Second Affiliated Hospital, SooChow University
Suzhou, China, 215004
Completed
78
Shanxi Provincial Cancer hospital
Taiyuan, China, 30013
Completed
79
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Completed
80
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
81
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
82
Hubei Cancer Hospital
Wuhan, China, 430079
Actively Recruiting
83
The first affiliated hospital of xiamen university
Xiamen, China, 361003
Completed
84
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China, 221000
Completed
85
Henan Cancer Hospital
Zhengzhou, China, 450008
Completed
86
The Fifth Affiliated Hospital Sun Yat Sen University
Zhuhai, China, 519000
Actively Recruiting
87
Klinicki bolnicki centar Zagreb
Zagreb, Croatia, 10000
Completed
88
Nemocnice Bulovka
Prague, Czechia, 180 81
Active, Not Recruiting
89
Tampereen Yliopistollinen Sairaala
Tampere, Finland, 33520
Completed
90
CHU Amiens Picardie
Amiens, France, 80000
Actively Recruiting
91
CHU Brest
Brest, France, 29609
Actively Recruiting
92
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
93
Centre Georges Francois Leclerc
Dijon, France, 21000
Actively Recruiting
94
Centre de Lutte contre le Cancer Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
95
Centre Leon Berard
Lyon, France, 69008
Completed
96
Hopital de la Timone
Marseille, France, 13385
Actively Recruiting
97
Clinique Ambroise Pare
Neuilly-sur-Seine, France, 92200
Completed
98
Hopital Europeen Georges Pompidou
Paris, France, 75015
Actively Recruiting
99
Institut Curie
Paris, France, 75248
Actively Recruiting
100
Hopital Tenon
Paris, France, 75970
Actively Recruiting
101
Hopital Haut Leveque
Pessac, France, 33604
Actively Recruiting
102
Hopital Pontchaillou
Rennes, France, 35000
Actively Recruiting
103
CLCC - Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
104
CHU Saint Etienne
Saint-Etienne, France, 42055
Actively Recruiting
105
Centre Hospitalier de Valenciennes Hopital Jean Bernard
Valenciennes, France, 59322
Completed
106
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
107
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
108
High Technology Hospital MedCenter Ltd Batumi
Batumi, Georgia, 6000
Actively Recruiting
109
JSC Vian Kutaisi Referral Hospital
Kutaisi, Georgia, 4600
Actively Recruiting
110
Todua Clinic
Tbilisi, Georgia, 0112
Completed
111
Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia, 144
Actively Recruiting
112
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany, 35392
Actively Recruiting
113
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
114
Universitatsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
115
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, Germany, 81675
Completed
116
Universitaetsmedizin Rostock
Rostock, Germany, 18059
Actively Recruiting
117
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, Greece, 124 62
Actively Recruiting
118
University Hospital Of Larissa
Larissa, Greece, 41110
Actively Recruiting
119
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece, 54639
Actively Recruiting
120
Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece, 57001
Completed
121
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, Hungary, 1062
Completed
122
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
Actively Recruiting
123
Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
Szeged, Hungary, 6720
Actively Recruiting
124
M S Ramaiah Memorial Hospital
Bangalore, India, 560054
Actively Recruiting
125
Apollo Speciality Hospital, Chennai
Chennai, India, 600035
Completed
126
Meenakshi Mission Hospital and Research Center
Madurai, India, 625107
Completed
127
Tata Memorial Hospital
Mumbai, India, 400012
Actively Recruiting
128
HealthCare Global HCG Manavata Cancer Centre
Nashik, India, 422002
Actively Recruiting
129
Rajiv Gandhi Cancer Institute and Research Centre
New Delh, India, 110085
Actively Recruiting
130
Grant Medical foundation Ruby Hall Clinic
Pune, India, 411 001
Completed
131
HCG cancer center
Vijayawada, India, 520002
Actively Recruiting
132
Samson Assuta Ashdod University Hospital
Ashdod, Israel, 7747629
Completed
133
Rambam Health Care Campus
Haifa, Israel, 3109601
Completed
134
Hadassah Medical Center
Jerusalem, Israel, 9112001
Completed
135
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Completed
136
Tokyo Medical and Dental University Hospital
Bunkyō City, Japan, 113-8519
Actively Recruiting
137
Hiroshima University Hospital
Hiroshima, Japan, 734 8551
Actively Recruiting
138
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
139
Aichi Cancer Center
Nagoya, Japan, 464-8681
Actively Recruiting
140
Osaka International Cancer Institute
Osaka, Japan, 541 8567
Actively Recruiting
141
Kindai University Hospital
Osaka Sayama Shi, Japan, 589 8511
Completed
142
Tohoku University Hospital
Sendai, Japan, 980 8574
Actively Recruiting
143
Jichi Medical University Hospital
Shimotsuke, Japan, 329-0498
Actively Recruiting
144
Tokyo Medical University Hospital
Shinjuku, Japan, 160 0023
Actively Recruiting
145
Shizuoka Cancer Center
Sunto Gun, Japan, 411 8777
Actively Recruiting
146
University of Perpetual Help Dalta Medical Center, Inc
Las Piñas, Philippines, 1742
Completed
147
Manila Doctors Hospital
Manila, Philippines, 1000
Completed
148
The Medical City
Pasig, Philippines, 1600
Actively Recruiting
149
St. Luke's Medical Center
Quezon City, Philippines, 1112
Actively Recruiting
150
Uls Braga - Hosp. Braga
Braga, Portugal, 4710 243
Completed
151
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal, 1649 035
Completed
152
Hosp. Cuf Descobertas
Lisbon, Portugal, 1998050
Actively Recruiting
153
Uls Santo Antonio - Hosp. Santo Antonio
Porto, Portugal, 4099-001
Completed
154
Uls Gaia Espinho
Vila Nova de Gaia, Portugal, 4434 502
Actively Recruiting
155
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
Bucharest, Romania, 22328
Actively Recruiting
156
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Completed
157
Vojnomedicinska Akademija
Belgrade, Serbia, 11000
Completed
158
Institute of Oncology of Vojvodina
Kamenitz, Serbia, 21204
Completed
159
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Completed
160
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
161
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
162
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea, 06591
Actively Recruiting
163
The Catholic university of Korea, St. Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
164
Hosp. Univ. de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
165
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Completed
166
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
167
Instituto Catalan Deoncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
168
Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
Las Palmas de Gran Canaria, Spain, 35001
Completed
169
Hosp. Univ. Lucus Augusti
Lugo, Spain, 27003
Actively Recruiting
170
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
171
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
172
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
173
Hosp Univ Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
174
Hosp Regional Univ de Malaga
Málaga, Spain, 29010
Actively Recruiting
175
Hosp. de Navarra
Pamplona, Spain, 31008
Completed
176
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
177
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
178
Inst. Valenciano de Oncologia
Valencia, Spain, 46009
Actively Recruiting
179
Hosp. Gral. Univ. Valencia
Valencia, Spain, 46014
Actively Recruiting
180
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
181
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 41345
Completed
182
National Cheng Kung University Hospital
Bei Qu, Taiwan, 704
Actively Recruiting
183
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
184
Chang-Gung Memorial Hospital-Keelung
Keelung, Taiwan, 20442
Actively Recruiting
185
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
186
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
187
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
188
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
189
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
190
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
191
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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