A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Trial Title: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT ID: NCT04988295

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Amivantamab-vmjw
Lazertinib

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lazertinib
Description: Lazertinib will be administered orally.
Arm group label: Arm A2 (Extension Cohort): ACP-L
Arm group label: Arm A: LACP/ACP-L

Other name: JNJ-73841937

Other name: YH-25448

Intervention type: Drug
Intervention name: Amivantamab
Description: Amivantamab will be administered as an IV infusion.
Arm group label: Arm A2 (Extension Cohort): ACP-L
Arm group label: Arm A: LACP/ACP-L
Arm group label: Arm C2 (Extension Cohort): ACP
Arm group label: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)

Other name: JNJ-61186372

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed will be administered as an IV infusion.
Arm group label: Arm A2 (Extension Cohort): ACP-L
Arm group label: Arm A: LACP/ACP-L
Arm group label: Arm B: CP (Carboplatin and Pemetrexed)
Arm group label: Arm C2 (Extension Cohort): ACP
Arm group label: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin will be administered as an IV infusion.
Arm group label: Arm A2 (Extension Cohort): ACP-L
Arm group label: Arm A: LACP/ACP-L
Arm group label: Arm B: CP (Carboplatin and Pemetrexed)
Arm group label: Arm C2 (Extension Cohort): ACP
Arm group label: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)

Summary: The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated - Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation - A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease - Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 - Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade <= 2 peripheral neuropathy, or Grade <= 2 hypothyroidism stable on hormone replacement) - A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study - Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8) Exclusion Criteria: - Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization - Participant with symptomatic or progressive brain metastases - Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation - Participant has known small cell transformation - Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis - Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Southern Cancer Center, PC

Address:
City: Mobile
Zip: 36608
Country: United States

Facility:
Name: Arizona Oncology Associates

Address:
City: Tucson
Zip: 85711
Country: United States

Facility:
Name: City of Hope

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: Cedars Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Facility:
Name: University of California Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Rocky Mountain Cancer Centers

Address:
City: Colorado Springs
Zip: 80907
Country: United States

Facility:
Name: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Address:
City: Fort Lauderdale
Zip: 33308
Country: United States

Facility:
Name: University Cancer And Blood Center LLC

Address:
City: Athens
Zip: 30607
Country: United States

Facility:
Name: University of Mississippi Medical Center

Address:
City: Jackson
Zip: 39216
Country: United States

Facility:
Name: Nebraska Cancer Specialists

Address:
City: Grand Island
Zip: 68803
Country: United States

Facility:
Name: Astera Cancer Care

Address:
City: East Brunswick
Zip: 08816
Country: United States

Facility:
Name: TriHealth Network

Address:
City: Cincinnati
Zip: 45220
Country: United States

Facility:
Name: Providence Portland Medical Center

Address:
City: Portland
Zip: 97213
Country: United States

Facility:
Name: Kaiser Permanente Northwest

Address:
City: Portland
Zip: 97227
Country: United States

Facility:
Name: Alliance Cancer Specialists

Address:
City: Horsham
Zip: 19044
Country: United States

Facility:
Name: University of Pittsburgh Medical Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: Baptist Cancer Center

Address:
City: Memphis
Zip: 38120
Country: United States

Facility:
Name: Texas Oncology-Medical City Dallas

Address:
City: Dallas
Zip: 75230
Country: United States

Facility:
Name: Texas Oncology Baylor Charles A Sammons Cancer Center

Address:
City: Dallas
Zip: 75246
Country: United States

Facility:
Name: Texas Oncology

Address:
City: Grapevine
Zip: 76051
Country: United States

Facility:
Name: Oncology Consultants - Texas

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Texas Oncology - Northeast

Address:
City: Longview
Zip: 75601
Country: United States

Facility:
Name: University of Vermont Medical Center

Address:
City: Burlington
Zip: 05401
Country: United States

Facility:
Name: University of Virginia

Address:
City: Charlottesville
Zip: 22908
Country: United States

Facility:
Name: Virginia Cancer Specialists

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Blue Ridge Cancer Care

Address:
City: Wytheville
Zip: 24382
Country: United States

Facility:
Name: NorthWest Medical Specialties, PLLC

Address:
City: Puyallup
Zip: 98373
Country: United States

Facility:
Name: Compass Oncology

Address:
City: Vancouver
Zip: 98684
Country: United States

Facility:
Name: CINME Centro de Investigaciones Metabolicas

Address:
City: Caba
Zip: C1027AAP
Country: Argentina

Facility:
Name: IADT Instituto Argentino de Diagnostico y Tratamiento

Address:
City: Caba
Zip: C1122
Country: Argentina

Facility:
Name: Centro Medico Fleischer

Address:
City: Caba
Zip: C1414
Country: Argentina

Facility:
Name: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Address:
City: Caba
Zip: C1431FWO
Country: Argentina

Facility:
Name: Hospital Privado Universitario De Cordoba

Address:
City: Cordoba
Zip: X5016KEH
Country: Argentina

Facility:
Name: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Address:
City: Córdoba
Zip: 5000
Country: Argentina

Facility:
Name: Hospital Privado de la Comunidad

Address:
City: Mar del Plata
Zip: B7602CBM
Country: Argentina

Facility:
Name: Clínica Viedma

Address:
City: Viedma
Zip: R8500ACE
Country: Argentina

Facility:
Name: Grand Hopital de Charleroi, site Notre Dame

Address:
City: Charleroi
Zip: 6000
Country: Belgium

Facility:
Name: UZA

Address:
City: Edegem
Zip: 2650
Country: Belgium

Facility:
Name: UZ Gent

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: Jessa Ziekenhuis - Campus Virga Jesse

Address:
City: Hasselt
Zip: 3500
Country: Belgium

Facility:
Name: UZ Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: CHU Sart-Tilman

Address:
City: Liege
Zip: 4000
Country: Belgium

Facility:
Name: Clinique Saint Pierre

Address:
City: Ottignies
Zip: 1340
Country: Belgium

Facility:
Name: Cetus Oncologia

Address:
City: Belo Horizonte
Zip: 30110-017
Country: Brazil

Facility:
Name: CIONC Centro Integrado de Oncologia de Curitiba

Address:
City: Curitiba
Zip: 80810 050
Country: Brazil

Facility:
Name: Ynova Pesquisa Clinica

Address:
City: Florianopolis
Zip: 88020-210
Country: Brazil

Facility:
Name: Fundação São Francisco Xavier

Address:
City: Ipatinga
Zip: 35162 189
Country: Brazil

Facility:
Name: UPCO Unidade de Pesquisa Clinica em Oncologia

Address:
City: Pelotas
Zip: 96020 080
Country: Brazil

Facility:
Name: Associacao Hospitalar Moinhos de Vento

Address:
City: Porto Alegre
Zip: 90035-001
Country: Brazil

Facility:
Name: Hospital Ernesto Dornelles

Address:
City: Porto Alegre
Zip: 90160-093
Country: Brazil

Facility:
Name: Oncoclinicas Rio de Janeiro S A

Address:
City: Rio de Janeiro
Zip: 22250-905
Country: Brazil

Facility:
Name: Instituto D Or de Pesquisa e Ensino IDOR

Address:
City: Rio de Janeiro
Zip: 22281 100
Country: Brazil

Facility:
Name: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Address:
City: Rio de Janeiro
Zip: 22775 001
Country: Brazil

Facility:
Name: Nucleo de Oncologia da Bahia

Address:
City: Salvador
Zip: 40170 110
Country: Brazil

Facility:
Name: Hospital Sao Rafael

Address:
City: Salvador
Zip: 41253-190
Country: Brazil

Facility:
Name: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Address:
City: Santo Andre
Zip: 09060 650
Country: Brazil

Facility:
Name: Real e Benemerita Associacao Portuguesa de Beneficencia

Address:
City: Sao Paulo
Zip: 01323 900
Country: Brazil

Facility:
Name: Hospital Paulistano

Address:
City: Sao Paulo
Zip: 01323-000
Country: Brazil

Facility:
Name: Hospital Alemao Oswaldo Cruz

Address:
City: Sao Paulo
Zip: 01327 001
Country: Brazil

Facility:
Name: Fundacao Antonio Prudente A C Camargo Cancer Center

Address:
City: Sao Paulo
Zip: 01509 900
Country: Brazil

Facility:
Name: Onco Star SP Oncologia Ltda

Address:
City: Sao Paulo
Zip: 04543-000
Country: Brazil

Facility:
Name: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Address:
City: Sorocaba
Zip: 18030-005
Country: Brazil

Facility:
Name: Hospital Nove de Julho

Address:
City: São Paulo
Zip: 01409902
Country: Brazil

Facility:
Name: COT - Centro Oncologico do Triangulo S.A

Address:
City: Uberlandia
Zip: 38408-150
Country: Brazil

Facility:
Name: Multifunctional Hospital for Active Treatment 'Serdika'

Address:
City: Sofia
Zip: 1303
Country: Bulgaria

Facility:
Name: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Address:
City: Sofia
Zip: 1407
Country: Bulgaria

Facility:
Name: Specialized Hospital for Active Treatment in Oncology

Address:
City: Sofia
Zip: 1756
Country: Bulgaria

Facility:
Name: UMHAT Sofia Med

Address:
City: Sofia
Zip: 1797
Country: Bulgaria

Facility:
Name: Tom Baker Cancer Centre

Address:
City: Calgary
Zip: T2N 4N2
Country: Canada

Facility:
Name: British Columbia Cancer Agency

Address:
City: Vancouver
Zip: V5Z 4E6
Country: Canada

Facility:
Name: McGill University Health Centre

Address:
City: Montreal
Zip: H4A 3J1
Country: Canada

Facility:
Name: Cancer Hospital, Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Peking University People s Hospital

Address:
City: Beijing
Zip: 100044
Country: China

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Chinese PLA General Hospital

Address:
City: Beijing
Zip: 100853
Country: China

Facility:
Name: Beijing Chest hospital, Capital medical university

Address:
City: Beijing
Zip: 101199
Country: China

Facility:
Name: Hunan Cancer hospital

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Sichuan Cancer Hospital

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: West China Hospital Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400000
Country: China

Facility:
Name: Southwest Hospital

Address:
City: ChongQing
Zip: 400038
Country: China

Facility:
Name: The First Affiliated Hospital Sun Yat sen University

Address:
City: Guang Zhou
Zip: 510080
Country: China

Facility:
Name: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510120
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hang Zhou
Zip: 310022
Country: China

Facility:
Name: Second Affiliated Hospital, School of Medicine, Zhejiang University

Address:
City: Hangzhou
Zip: 310009
Country: China

Facility:
Name: The Second Affiliated Hospital of Zhejiang University College of Medicine

Address:
City: Hangzhou
Zip: 310009
Country: China

Facility:
Name: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Harbin medical university cancer hospital

Address:
City: Harbin
Zip: 150000
Country: China

Facility:
Name: Huizhou Municipal Central Hospital

Address:
City: Huizhou
Zip: 516001
Country: China

Facility:
Name: Taizhou Hospital of Zhejiang Province

Address:
City: Linhai
Zip: 317000
Country: China

Facility:
Name: Affiliated Hospital of North Sichuan Medical College

Address:
City: Nanchong
Country: China

Facility:
Name: Ruijin Hospital Shanghai Jiao Tong University

Address:
City: Shanghai
Zip: 200025
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Shanghai East Hospital

Address:
City: Shanghai
Zip: 310000
Country: China

Facility:
Name: Shenzhen university General Hospital

Address:
City: Shenzhen
Zip: 518055
Country: China

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences

Address:
City: Shenzhen
Zip: 518116
Country: China

Facility:
Name: Tianjin Medical University General Hospital

Address:
City: Tianjin
Zip: 300052
Country: China

Facility:
Name: Weifang People's Hospital

Address:
City: Weifang
Zip: 261000
Country: China

Facility:
Name: The First Affiliated Hospital of Xian Jiaotong University

Address:
City: XI An
Zip: 710061
Country: China

Facility:
Name: Yantai Yuhuangding Hospital

Address:
City: Yantai
Zip: 264000
Country: China

Facility:
Name: Daping Hospital Army Characteristic Medical Center

Address:
City: Yuzhong District
Zip: 400042
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Fakultni nemocnice Olomouc - I.P.Pavlova 6

Address:
City: Olomouc
Zip: 775 20
Country: Czechia

Facility:
Name: Vitkovicka nemocnice a.s.

Address:
City: Ostrava- Vitkovice
Zip: 70300
Country: Czechia

Facility:
Name: Fakultni nemocnice Plzen

Address:
City: Plzen
Zip: 30599
Country: Czechia

Facility:
Name: Rigshospitalet

Address:
City: Copenhagen
Zip: DK 2100
Country: Denmark

Facility:
Name: Institut Sainte Catherine

Address:
City: Avignon Cedex 9
Zip: 84918
Country: France

Facility:
Name: Hospices Civils de Lyon HCL

Address:
City: Bron
Zip: 69500
Country: France

Facility:
Name: CHU de Grenoble Hopital Albert Michallon

Address:
City: La Tronche
Zip: 38700
Country: France

Facility:
Name: Centre Hospitalier du Mans

Address:
City: le Mans
Zip: 72000
Country: France

Facility:
Name: CHR Hôpital Calmette

Address:
City: Lille
Zip: 59000
Country: France

Facility:
Name: Hopital Nord

Address:
City: Marseille Cedex 20
Zip: 13915
Country: France

Facility:
Name: CHU de Montpellier - Arnaud de Villeneuve

Address:
City: Montpellier Cedex 5
Zip: 34295
Country: France

Facility:
Name: Institut Curie

Address:
City: Paris
Zip: 75005
Country: France

Facility:
Name: CHU Bordeaux

Address:
City: Pessac
Zip: 33604
Country: France

Facility:
Name: CHRU Hopital de Pontchaillou

Address:
City: Rennes
Zip: 35033
Country: France

Facility:
Name: CHU Nantes

Address:
City: Sain-Herblain
Zip: 44800
Country: France

Facility:
Name: Nouvel Hopital Civil - CHU Strasbourg

Address:
City: Strasbourg cedex
Zip: 67091
Country: France

Facility:
Name: CHU Bretonneau

Address:
City: Tours
Zip: 37000
Country: France

Facility:
Name: Evangelische Lungenklinik Berlin

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: Asklepios Klinikum Harburg

Address:
City: Hamburg
Zip: 21075
Country: Germany

Facility:
Name: Thoraxklinik am Universitatsklinikum Heidelberg

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Onkologische Schwerpunktpraxis

Address:
City: Heilbronn
Zip: 74072
Country: Germany

Facility:
Name: POIS Sachsen GmbH iG

Address:
City: Leipzig
Zip: 04357
Country: Germany

Facility:
Name: Bethanien Krankenhaus

Address:
City: Moers
Zip: 47441
Country: Germany

Facility:
Name: Klinikum der Universitaet Muenchen

Address:
City: München
Zip: 80336
Country: Germany

Facility:
Name: Oncologianova GmbH

Address:
City: Recklinghausen
Zip: 45659
Country: Germany

Facility:
Name: Universitaetsklinikum Regensburg

Address:
City: Regensburg
Zip: 93053
Country: Germany

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: 999077
Country: Hong Kong

Facility:
Name: Health Care Global Enterprises pvt Ltd

Address:
City: Bangalore
Zip: 560027
Country: India

Facility:
Name: Artemis Hospital

Address:
City: Gurugram
Zip: 122001
Country: India

Facility:
Name: Tata Medical Center

Address:
City: Kolkata
Zip: 700160
Country: India

Facility:
Name: Tata Memorial Hospital

Address:
City: Mumbai
Zip: 400012
Country: India

Facility:
Name: HCG Manavta Cancer Centre

Address:
City: Nasik
Zip: 422002
Country: India

Facility:
Name: Rajiv Gandhi Cancer Institute and Research Centre

Address:
City: New Delh
Zip: 110085
Country: India

Facility:
Name: Noble Hospital Pvt Ltd

Address:
City: Pune
Zip: 411013
Country: India

Facility:
Name: Bhaktivedanta Hospital & Research Institute

Address:
City: Thane
Zip: 411107
Country: India

Facility:
Name: Soroka University Medical Center

Address:
City: Beersheba
Zip: 84101
Country: Israel

Facility:
Name: Rambam Health Corporation

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Shaare Zedek Medical Center

Address:
City: Jerusalem
Zip: 91031
Country: Israel

Facility:
Name: Meir Medical Center

Address:
City: Kfar Saba
Zip: 44281
Country: Israel

Facility:
Name: Rabin Medical Center

Address:
City: Petah Tikva
Zip: 49100
Country: Israel

Facility:
Name: Chaim Sheba Medical Center

Address:
City: Ramat Gan
Zip: 5262100
Country: Israel

Facility:
Name: Tel-Aviv Sourasky Medical Center

Address:
City: Tel-Aviv
Zip: 6423906
Country: Israel

Facility:
Name: CRO IRCCS Istituto Nazionale Tumori

Address:
City: Aviano
Zip: 33081
Country: Italy

Facility:
Name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: Istituto Europeo di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria Di Parma

Address:
City: Parma
Zip: 43126
Country: Italy

Facility:
Name: Ospedale S. Maria Delle Croci

Address:
City: Ravenna
Zip: 48121
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Regina Elena

Address:
City: Roma
Zip: 00144
Country: Italy

Facility:
Name: Policlinico G.B.Rossi

Address:
City: Verona
Zip: 37134
Country: Italy

Facility:
Name: National Hospital Organization Shibukawa Medical Center

Address:
City: Gunma
Zip: 377-0280
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Hyogo
Zip: 673-8558
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Kanagawa
Zip: 241-8515
Country: Japan

Facility:
Name: Kobe City Medical Center General Hospital

Address:
City: Kobe City
Zip: 650 0047
Country: Japan

Facility:
Name: Kurume University Hospital

Address:
City: Kurume
Zip: 830-0011
Country: Japan

Facility:
Name: National Hospital Organization Nagoya Medical Center

Address:
City: Nagoya-shi
Zip: 460-0001
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Osaka International Cancer Institute

Address:
City: Osaka City
Zip: 541 8567
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Shizuoka
Zip: 411 8777
Country: Japan

Facility:
Name: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Address:
City: Tokyo
Zip: 113 8677
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR

Address:
City: Tokyo
Zip: 135 8550
Country: Japan

Facility:
Name: Ehime University Hospital

Address:
City: Toon-shi
Zip: 791-0295
Country: Japan

Facility:
Name: Wakayama Medical University Hospital

Address:
City: Wakayama
Zip: 641 8510
Country: Japan

Facility:
Name: National Hospital Organization Iwakuni Clinical Center

Address:
City: Yamaguchi
Zip: 740-8510
Country: Japan

Facility:
Name: National Hospital Organization Yamaguchi Ube Medical Center

Address:
City: Yamaguchi
Zip: 755-0241
Country: Japan

Facility:
Name: National Cancer Center

Address:
City: Gyeonggi-do
Zip: 10408
Country: Korea, Republic of

Facility:
Name: CHA Bundang Medical Center, CHA University

Address:
City: Gyeonggi-do
Zip: 13496
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

Facility:
Name: GyeongSang National University Hospital

Address:
City: Gyeongsangnam-do
Zip: 52727
Country: Korea, Republic of

Facility:
Name: Korea University Anam Hospital

Address:
City: Seoul
Zip: 02841
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Seoul St Mary s Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: University Malaya Medical Centre

Address:
City: Kuala Lumpur
Country: Malaysia

Facility:
Name: Hospital Tengku Ampuan Afzan

Address:
City: Kuantan
Zip: 25100
Country: Malaysia

Facility:
Name: Beacon Hospital Sdn Bhd

Address:
City: Petaling Jaya
Zip: 46050
Country: Malaysia

Facility:
Name: Subang Jaya Medical Centre

Address:
City: Subang Jaya
Zip: 47500
Country: Malaysia

Facility:
Name: Mount Miriam Cancer Hospital

Address:
City: Tanjung Bungah
Zip: 11200
Country: Malaysia

Facility:
Name: Hospital Civil de Guadalajara Fray Antonio Alcalde

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: CIMOVA, Morals Vargas Centro de Investigación SC

Address:
City: Leon
Zip: 37000
Country: Mexico

Facility:
Name: Health Pharma Professional Research

Address:
City: Mexico
Zip: 03100
Country: Mexico

Facility:
Name: Instituto Nacional de Cancerologia

Address:
City: Mexico
Zip: 14080
Country: Mexico

Facility:
Name: Oncologia Integral Satelite

Address:
City: Naucalpan
Zip: 53100
Country: Mexico

Facility:
Name: VUMC Amsterdam

Address:
City: Amsterdam
Zip: 1081 HV
Country: Netherlands

Facility:
Name: Ziekenhuis St Jansdal

Address:
City: Harderwijk
Zip: 3844 DG
Country: Netherlands

Facility:
Name: Erasmus MC

Address:
City: Rotterdam
Zip: 3015 GD
Country: Netherlands

Facility:
Name: Centrum Onkologii im. Prof. F. Lukaszczyka

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Facility:
Name: Uniwersyteckie Centrum Kliniczne

Address:
City: Gdansk
Zip: 80-952
Country: Poland

Facility:
Name: Szpitale Pomorskie Sp z o o

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Facility:
Name: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

Address:
City: Poznan
Zip: 60 569
Country: Poland

Facility:
Name: Private Specialist Hospitals - MedPolonia

Address:
City: Poznan
Zip: 60-693
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

Address:
City: Lisboa
Zip: 1769-001
Country: Portugal

Facility:
Name: Hospital Beatriz Angelo

Address:
City: Loures
Zip: 2674 514
Country: Portugal

Facility:
Name: Centro Hospitalar Universitario do Porto, EPE

Address:
City: Porto
Zip: 4099-001
Country: Portugal

Facility:
Name: Instituto Portugues de Oncologia

Address:
City: Porto
Zip: 4200072
Country: Portugal

Facility:
Name: Pan American Center for Oncology Trials LLC

Address:
City: Rio Piedras
Zip: 00917
Country: Puerto Rico

Facility:
Name: City Clinical Hospital #1

Address:
City: Nalchik
Zip: 360000
Country: Russian Federation

Facility:
Name: Llc, Eurocityclinic

Address:
City: Saint Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: Hosp Univ A Coruna

Address:
City: A Coruña
Zip: 15006
Country: Spain

Facility:
Name: Hosp. de La Santa Creu I Sant Pau

Address:
City: Barcelona
Zip: 08025
Country: Spain

Facility:
Name: Hosp. Univ. Quiron Dexeus

Address:
City: Barcelona
Zip: 08028
Country: Spain

Facility:
Name: Hosp Univ Vall D Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hosp Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hosp. Univ. Insular de Gran Canaria

Address:
City: Las Palmas de Gran Canaria
Zip: 35016
Country: Spain

Facility:
Name: Hosp. Gral. Univ. Gregorio Maranon

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: Hosp Univ Fund Jimenez Diaz

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hosp. Univ. 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hosp. Univ. La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hosp Univ Hm Sanchinarro

Address:
City: Madrid
Zip: 28050
Country: Spain

Facility:
Name: Hosp. Univ. Pta. de Hierro Majadahonda

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hosp Regional Univ de Malaga

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: Clinica Univ. de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hosp. Virgen Del Rocio

Address:
City: Seville
Zip: 41013
Country: Spain

Facility:
Name: Hosp. Gral. Univ. Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Hosp. Univ. I Politecni La Fe

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Sahlgrenska Universitetssjukhuset

Address:
City: Goteborg
Zip: 413 45
Country: Sweden

Facility:
Name: Linkoping University Hospital

Address:
City: Linkoping
Zip: 581 85
Country: Sweden

Facility:
Name: Skanes universitetssjukhus

Address:
City: Lund
Zip: 221 85
Country: Sweden

Facility:
Name: Norrlands Universitetssjukhus

Address:
City: Umea
Zip: 901 85
Country: Sweden

Facility:
Name: Akademiska Sjukhuset

Address:
City: Uppsala
Zip: 75181
Country: Sweden

Facility:
Name: Changhua Christian Hospital

Address:
City: Changhua
Zip: 500
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: Taipei Medical University Shuang Ho Hospital

Address:
City: New Taipei City
Zip: 23561
Country: Taiwan

Facility:
Name: Chung Shan Medical University Hospital

Address:
City: Taichung
Zip: 402
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 100
Country: Taiwan

Facility:
Name: Adana City Hospital

Address:
City: Adana
Zip: 01060
Country: Turkey

Facility:
Name: Memorial Ankara Hastanesi

Address:
City: Ankara
Zip: 06520
Country: Turkey

Facility:
Name: Gazi University Hospital

Address:
City: Ankara
Zip: 06560
Country: Turkey

Facility:
Name: Ankara Bilkent City Hospital

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: Trakya University Medical Faculty

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Istanbul University Cerrahpasa Medical Faculty

Address:
City: Istanbul
Zip: 34098
Country: Turkey

Facility:
Name: Bakirkoy Training and Research Hospital

Address:
City: Istanbul
Zip: 34147
Country: Turkey

Facility:
Name: Medipol Mega University Hospital

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Medical Point

Address:
City: Izmir
Zip: 35575
Country: Turkey

Facility:
Name: Velindre Hospital

Address:
City: Cardiff
Zip: CF14 2TL
Country: United Kingdom

Facility:
Name: Edinburgh Cancer Centre Western General

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: UCL Cancer Institute

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Guys and St Thomas NHS Foundation Trust

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: The Royal Marsden NHS Trust

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: The Christie Nhs Foundation Trust

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Start date: November 17, 2021

Completion date: June 30, 2026

Lead sponsor:
Agency: Janssen Research & Development, LLC
Agency class: Industry

Source: Janssen Research & Development, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04988295