AzTrials
AzTrials

Carcinoma, Squamous CellPhase 3NCT04892173

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

A Phase 3 study testing JNJ-90301900 (NBTXR3), Cetuximab and Radiation Therapy in people with Carcinoma, Squamous Cell, run by Johnson & Johnson Enterprise Innovation Inc. at 196 sites in 27 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Carcinoma, Squamous Cell
What is being tested?
JNJ-90301900 (NBTXR3), Cetuximab and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
196 sitesin 27 countries
Study dates
10 Dec 2021to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

196 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

196 sites in 27 countries

China35 sites, 22 recruiting

  • The Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

    Completed

  • Xiangya Hospital Central South University

    Changsha, 410008

    Completed

  • Hunan Cancer hospital

    Changsha, 410013

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Recruiting

  • Dongguan People s Hospital

    Dongguan, 523109

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Completed

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

    Recruiting

  • Fujian Medical University Fujian Provincial Cancer Hospital

    Fuzhou, 350014

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, 510080

    Recruiting

  • Guangzhou Medical University Affiliated Oncology Hospital

    Guangzhou, 510095

    Recruiting

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • Linyi Cancer Hospital

    Linyi, 276002

    Recruiting

  • Liuzhou people's Hospital

    Liuzhou, 545006

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, 330029

    Completed

  • Jiangsu Cancer Hospital

    Nanjing, 210009

    Completed

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 223800

    Recruiting

  • Wuming Hospital of Guangxi Medical University

    Nanning, 530000

    Recruiting

  • The Cancer Hospital Affiliated to Guangxi Medical University

    Nanning, 530021

    Recruiting

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Completed

  • Liaoning Cancer Hospital and Institute

    Shenyang, 110042

    Completed

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, 50011

    Recruiting

  • Second Affiliated Hospital, SooChow University

    Suzhou, 215004

    Completed

  • Shanxi Provincial Cancer hospital

    Taiyuan, 30013

    Completed

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

    Completed

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022

    Recruiting

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

  • The first affiliated hospital of xiamen university

    Xiamen, 361003

    Completed

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221000

    Completed

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Completed

  • The Fifth Affiliated Hospital Sun Yat Sen University

    Zhuhai, 519000

    Recruiting

Other trials in China

United States26 sites, 22 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • University of California at San Diego Moores Cancer Center

    La Jolla, California, 92093

    Recruiting

  • Memorial Radiation Oncology Medical Group Laguna Hills

    Laguna Hills, California, 92653

    Completed

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

    Recruiting

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

    Recruiting

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York, 10032

    Completed

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

    Completed

  • Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University

    Norfolk, Virginia, 23507

    Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Recruiting

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Recruiting

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    Completed

  • Richmond University Medical Center

    Staten Island, New York, 10310

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • George Washington University Cancer Center

    Washington D.C., District of Columbia, 20052

    Recruiting

Other trials in United States

Spain19 sites, 15 recruiting

  • Hosp. Univ. de Cruces

    Barakaldo, 48903

    Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036

    Completed

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Instituto Catalan Deoncologia Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario

    Las Palmas de Gran Canaria, 35001

    Completed

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

    Completed

  • Hosp Regional Univ de Malaga

    Málaga, 29010

    Recruiting

  • Hosp. de Navarra

    Pamplona, 31008

    Completed

  • Hosp.Univ.Parc Tauli

    Sabadell, 08208

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

  • Inst. Valenciano de Oncologia

    Valencia, 46009

    Recruiting

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

    Recruiting

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

France18 sites, 15 recruiting

  • CHU Amiens Picardie

    Amiens, 80000

    Recruiting

  • CHU Brest

    Brest, 29609

    Recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21000

    Recruiting

  • Centre de Lutte contre le Cancer Centre Oscar Lambret

    Lille, 59020

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Completed

  • Hopital de la Timone

    Marseille, 13385

    Recruiting

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

    Completed

  • Hopital Europeen Georges Pompidou

    Paris, 75015

    Recruiting

  • Institut Curie

    Paris, 75248

    Recruiting

  • Hopital Tenon

    Paris, 75970

    Recruiting

  • Hopital Haut Leveque

    Pessac, 33604

    Recruiting

  • Hopital Pontchaillou

    Rennes, 35000

    Recruiting

  • CLCC - Centre Henri Becquerel

    Rouen, 76038

    Recruiting

  • CHU Saint Etienne

    Saint-Etienne, 42055

    Recruiting

  • Centre Hospitalier de Valenciennes Hopital Jean Bernard

    Valenciennes, 59322

    Completed

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Brazil16 sites, 14 recruiting

  • Fundacao Pio XII

    Barretos, 14784-400

    Recruiting

  • Nucleo de Ensino e Pesquisa do Instituto Mario Penna

    Belo Horizonte, 30380 472

    Recruiting

  • Centro Regional Integrado de Oncologia CRIO

    Fortaleza, 60336 232

    Completed

  • Instituto Do Cancer Do Ceara

    Fortaleza, 60430-230

    Recruiting

  • Fundacao Sao Francisco Xavier

    Ipatinga, 35160 158

    Recruiting

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

    Recruiting

  • Hospital do Cancer de Londrina

    Londrina, 86015 520

    Recruiting

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050 170

    Recruiting

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

    Recruiting

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, 91350-200

    Completed

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905

    Recruiting

  • Ensino e Terapia de Inovacao Clinica AMO Etica

    Salvador, 41950 640

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

    Recruiting

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 050

    Recruiting

  • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

    Vitória, 29043 260

    Recruiting

Other trials in Brazil

Japan10 sites, 9 recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113-8519

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734 8551

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    Recruiting

  • Aichi Cancer Center

    Nagoya, 464-8681

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541 8567

    Recruiting

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511

    Completed

  • Tohoku University Hospital

    Sendai, 980 8574

    Recruiting

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023

    Recruiting

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777

    Recruiting

Other trials in Japan

India8 sites, 5 recruiting

  • M S Ramaiah Memorial Hospital

    Bangalore, 560054

    Recruiting

  • Apollo Speciality Hospital, Chennai

    Chennai, 600035

    Completed

  • Meenakshi Mission Hospital and Research Center

    Madurai, 625107

    Completed

  • Tata Memorial Hospital

    Mumbai, 400012

    Recruiting

  • HealthCare Global HCG Manavata Cancer Centre

    Nashik, 422002

    Recruiting

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, 110085

    Recruiting

  • Grant Medical foundation Ruby Hall Clinic

    Pune, 411 001

    Completed

  • HCG cancer center

    Vijayawada, 520002

    Recruiting

Other trials in India

United Kingdom6 sites, 6 recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

    Recruiting

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX

    Recruiting

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

    Recruiting

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Recruiting

Other trials in United Kingdom

Germany5 sites, 2 recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Completed

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    München, 81675

    Completed

  • Universitaetsmedizin Rostock

    Rostock, 18059

    Completed

Other trials in Germany

Portugal5 sites, 2 recruiting

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

    Completed

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035

    Completed

  • Hosp. Cuf Descobertas

    Lisbon, 1998050

    Recruiting

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099-001

    Completed

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

    Recruiting

Other trials in Portugal

Taiwan5 sites, 5 recruiting

  • National Cheng Kung University Hospital

    Bei Qu, 704

    Recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Recruiting

  • Chang-Gung Memorial Hospital-Keelung

    Keelung, 20442

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

Other trials in Taiwan

Austria4 sites, 3 recruiting

  • Medizinische Universitat Graz

    Graz, 8036

    Completed

  • Medical University Innsbruck

    Innsbruck, 6020

    Recruiting

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

    Recruiting

  • Medizinische Universitaet Wien

    Vienna, 1090

    Recruiting

Other trials in Austria

Georgia4 sites, 3 recruiting

  • High Technology Hospital MedCenter Ltd Batumi

    Batumi, 6000

    Recruiting

  • JSC Vian Kutaisi Referral Hospital

    Kutaisi, 4600

    Recruiting

  • Todua Clinic

    Tbilisi, 0112

    Completed

  • Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 144

    Recruiting

Other trials in Georgia

Greece4 sites, 3 recruiting

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

    Athens, 124 62

    Recruiting

  • University Hospital Of Larissa

    Larissa, 41110

    Recruiting

  • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 54639

    Recruiting

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 57001

    Completed

Other trials in Greece

Israel4 sites

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

    Active, not recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Completed

  • Hadassah Medical Center

    Jerusalem, 9112001

    Completed

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Completed

Other trials in Israel

Philippines4 sites

  • University of Perpetual Help Dalta Medical Center, Inc

    Las Piñas, 1742

    Completed

  • Manila Doctors Hospital

    Manila, 1000

    Completed

  • The Medical City

    Pasig, 1600

    Active, not recruiting

  • St. Luke's Medical Center

    Quezon City, 1112

    Completed

Other trials in Philippines

Serbia4 sites

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

    Completed

  • Vojnomedicinska Akademija

    Belgrade, 11000

    Completed

  • Institute of Oncology of Vojvodina

    Kamenitz, 21204

    Completed

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Completed

Other trials in Serbia

South Korea4 sites, 3 recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

    Completed

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon, 16247

    Recruiting

Other trials in South Korea

Belgium3 sites, 2 recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Recruiting

  • Grand Hopital De Charleroi Site Les Viviers

    Charleroi, 6060

    Completed

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Hungary3 sites, 2 recruiting

  • Eszak Pesti Centrumkorhaz Honvedkorhaz

    Budapest, 1062

    Completed

  • Orszagos Onkologiai Intezet

    Budapest, 1122

    Recruiting

  • Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika

    Szeged, 6720

    Recruiting

Other trials in Hungary

Bulgaria2 sites

  • MHAT Uni Hospital

    Panagyurishte, 4500

    Completed

  • Specialized Hospital for Active Treatment in Oncology

    Sofia, 1756

    Completed

Other trials in Bulgaria

Czechia2 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Completed

  • Nemocnice Bulovka

    Prague, 180 81

    Active, not recruiting

Other trials in Czechia

Canada1 site, 1 recruiting

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

    Recruiting

Other trials in Canada

Croatia1 site

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000

    Completed

Other trials in Croatia

Finland1 site

  • Tampereen Yliopistollinen Sairaala

    Tampere, 33520

    Completed

Other trials in Finland

Romania1 site

  • Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti

    Bucharest, 22328

    Active, not recruiting

Other trials in Romania

Sweden1 site

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345

    Completed

Other trials in Sweden

About this study

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

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).

Being tested
JNJ-90301900 (NBTXR3), Cetuximab, Radiation Therapy
Keywords
LA-HNSCC, NBTXR3, hafnium oxide, radioenhancer, Radiotherapy, RT, HNSCC, radiation therapy
Medical subject headings
Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-90301900 (NBTXR3)Drug

    Also called Functionalized hafnium oxide nanoparticles, NBTXR3

    Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.

  • CetuximabDrug

    Also called Erbitux

    Solution for infusion

  • Radiation TherapyRadiation

    Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.

Study groups in NCT04892173
Study groupRoleWhat they receive
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.
Receives: Drug: JNJ-90301900 (NBTXR3); Drug: Cetuximab; Radiation: Radiation Therapy
Arm B: RT alone or RT in combination with cetuximabActive comparatorInvestigator's choice of RT alone or RT in combination with cetuximab.
Receives: Drug: Cetuximab; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 months following first randomized participant

Secondary outcomes (10)

  1. Overall Survival (OS)

    Time from randomization to death from any cause.

    Measured: 48 months following first randomized participant

  2. Local-regional control

    Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.

    Measured: 48 months following first randomized participant

  3. Distant control

    Time to distant progression: time from randomization to distant progression or death, whichever occurs first.

    Measured: 48 months following first randomized participant

  4. Quality of Life over time - QLQ H&N35

    Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H\&N35).

    Measured: 48 months following first randomized participant

  5. Quality of Life over time - EQ 5D 5L

    Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument.

    Measured: 48 months following first randomized participant

  6. Safety across duration of study - AEs

    Adverse events (AEs).

    Measured: 48 months following first randomized participant

  7. Objective Response Rate (ORR)

    Rate of complete response (CR)+partial response (PR) [RESIST 1.1].

    Measured: 48 months following first randomized participant

  8. Duration of Overall Response

    Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first.

    Measured: 48 months following first randomized participant

  9. Head and Neck Cancer Specific Event-Free Survival

    Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first.

    Measured: 48 months following first randomized participant

  10. Head and Neck Cancer-Specific Survival

    Time from randomization to head and neck cancer-related death.

    Measured: 48 months following first randomized participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start10 Dec 2021
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892173
Sponsor's protocol ID
NANORAY-312
Other IDs
NANORAY-312, 2024-520386-31-00
Status last verified
Nov 2026
First submitted
4 May 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40323213

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JNJ-90301900 (NBTXR3), Cetuximab and Radiation Therapy in people with Carcinoma, Squamous Cell, run by Johnson & Johnson Enterprise Innovation Inc. at 196 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in China, United States, Spain, France, Brazil and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Based on Independent Central Review (ICR) (time frame: 30 months following first randomized participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04892173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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