JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
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
2 other identifiers
interventional
500
26 countries
186
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2021
Longer than P75 for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
December 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 27, 2026
April 1, 2026
6.6 years
May 4, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
30 months following first randomized participant
Secondary Outcomes (10)
Overall Survival (OS)
48 months following first randomized participant
Local-regional control
48 months following first randomized participant
Distant control
48 months following first randomized participant
Quality of Life over time - QLQ H&N35
48 months following first randomized participant
Quality of Life over time - EQ 5D 5L
48 months following first randomized participant
- +5 more secondary outcomes
Study Arms (2)
Arm A: JNJ-90301900 (NBTXR3)
EXPERIMENTALJNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
Arm B: RT alone or RT in combination with cetuximab
ACTIVE COMPARATORInvestigator's choice of RT alone or RT in combination with cetuximab.
Interventions
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Solution for infusion
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
Eligibility Criteria
You may qualify if:
- 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):
- Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
- Grade \>= 2 hearing loss or tinnitus,
- Grade \>= 2 peripheral neuropathy,
- New York Heart Association Class 3
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (190)
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
Liuchow, 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
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 Delh, 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
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 Foundation Trust
London, SW3 6JJ, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
Le Tourneau C, Takacsi-Nagy Z, Nuyts S, Thureau S, Liu F, Hoffmann C, Hackman TG, Lesnik M, Debard A, Finzi L, Devisetty K, Vivar OI, Farber LA, Nguyen F, Liem X, Natelauri E, Psyrri A, Burian M, Yu J, Yom SS. Nanoray-312: phase III study of NBTXR3 + radiotherapy +/- cetuximab in elderly, platinum-ineligible locally advanced HNSCC. Future Oncol. 2025 May;21(12):1489-1499. doi: 10.1080/14796694.2025.2496131. Epub 2025 May 5.
PMID: 40323213DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Enterprise Innovation Inc Clinical trial
Johnson & Johnson Enterprise Innovation Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 19, 2021
Study Start
December 10, 2021
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share