A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

Trial Title: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT ID: NCT04538664

Condition: Carcinoma, Non-Small-Cell Lung

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

Conditions: Keywords:
EGFR Exon20ins Mutation
NSCLC

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: Amivantamab
Description: Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.
Arm group label: Arm A: Amivantamab + Chemotherapy

Other name: JNJ-61186372

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.
Arm group label: Arm A: Amivantamab + Chemotherapy

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Arm group label: Arm A: Amivantamab + Chemotherapy
Arm group label: Arm B: Chemotherapy Alone

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.
Arm group label: Arm B: Chemotherapy Alone

Summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation - Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream - A female participant of childbearing potential must have a negative serum or urine 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 Exclusion Criteria: - Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance) - Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) - Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation - Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis - Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope

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

Facility:
Name: University of California Irvine

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

Facility:
Name: UCLA

Address:
City: Santa Monica
Zip: 90404
Country: United States

Facility:
Name: Georgetown University Hospital

Address:
City: Washington
Zip: 20007
Country: United States

Facility:
Name: H. Lee Moffitt Cancer & Research Institute

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: University Cancer And Blood Center LLC

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

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Washington University Medical Center

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: Regional Cancer Care Associates LLC

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

Facility:
Name: Langone Health at NYC University, NYU School of Medicine

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: Columbia University Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Facility:
Name: Providence Portland Medical Center

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

Facility:
Name: Sanford Health

Address:
City: Sioux Falls
Zip: 57104
Country: United States

Facility:
Name: Texas Oncology Pa

Address:
City: Tyler
Zip: 75702
Country: United States

Facility:
Name: Utah Cancer Specialists

Address:
City: Salt Lake City
Zip: 84106
Country: United States

Facility:
Name: Virginia Cancer Specialists

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

Facility:
Name: Blue Ridge Cancer Care

Address:
City: Salem
Zip: 24153
Country: United States

Facility:
Name: Chris O'Brien Lifehouse

Address:
City: Camperdown
Zip: 2050
Country: Australia

Facility:
Name: St George Hospital

Address:
City: Kogarah
Zip: 2217
Country: Australia

Facility:
Name: Cabrini Medical Centre

Address:
City: Malvern
Zip: 3144
Country: Australia

Facility:
Name: Sir Charles Gairdner Hospital

Address:
City: Nedlands
Zip: 6009
Country: Australia

Facility:
Name: UZ Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: Algemeen Ziekenhuis Delta

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Facility:
Name: CHU UCL Namur - Site Godinne

Address:
City: Yvoir
Zip: 5530
Country: Belgium

Facility:
Name: Fundacao Pio XII

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: Cetus Oncologia

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

Facility:
Name: Ynova Pesquisa Clinica

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

Facility:
Name: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Liga Norte Riograndense Contra O Cancer

Address:
City: Natal
Zip: 59062 000
Country: Brazil

Facility:
Name: UPCO Unidade de Pesquisa Clinica em Oncologia

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

Facility:
Name: Irmandade Santa Casa de Misericordia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Facility:
Name: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: Ministerio da Saude Instituto Nacional do Cancer

Address:
City: Rio De Janeiro
Zip: 20231 050
Country: Brazil

Facility:
Name: Oncoclinicas Rio de Janeiro S A

Address:
City: Rio de Janeiro
Zip: 22 250 905
Country: Brazil

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

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

Facility:
Name: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

Address:
City: Sao Paulo
Zip: 01246 000
Country: Brazil

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

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

Facility:
Name: Núcleo de Pesquisa São Camilo

Address:
City: Sao Paulo
Zip: 04014-002
Country: Brazil

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

Address:
City: Sorocaba
Zip: 18030-075
Country: Brazil

Facility:
Name: Hospital Evangélico de Cachoeiro de Itapemirim

Address:
City: Vitoria
Zip: 29308-014
Country: Brazil

Facility:
Name: The Ottawa Hospital Cancer Centre

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: Sunnybrook Health Sciences Centre

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Facility:
Name: McGill University Health Centre

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

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: Peking University International Hospital

Address:
City: Beijing
Zip: 102206
Country: China

Facility:
Name: Jilin cancer hospital

Address:
City: Changchun
Zip: 130000
Country: China

Facility:
Name: Hunan Cancer hospital

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: The First People's Hospital Of Changzhou

Address:
City: Changzhou
Zip: 213003
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: 400030
Country: China

Facility:
Name: Fujian Medical University Union Hospital

Address:
City: Fuzhou
Zip: 350001
Country: China

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

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

Facility:
Name: Zhejiang Cancer Hospital

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

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

Address:
City: Hangzhou
Zip: 310003
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: Taizhou Hospital of Zhejiang Province

Address:
City: Linhai
Zip: 317000
Country: China

Facility:
Name: Nanjing Drum Tower Hospital

Address:
City: Nanjing
Zip: 210031
Country: China

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Zip: 200030
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: 200123
Country: China

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Facility:
Name: Shengjing Hospital Of China Medical University

Address:
City: Shenyang
Zip: 110004
Country: China

Facility:
Name: Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

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: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Facility:
Name: Hospital of Jiangnan University

Address:
City: Wuxi
Zip: 214122
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: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Institut Bergonie

Address:
City: Bordeaux
Zip: 33000
Country: France

Facility:
Name: Hospices Civils de Lyon HCL

Address:
City: Bron
Zip: 69500
Country: France

Facility:
Name: Centre Georges Francois Leclerc

Address:
City: Dijon
Zip: 21000
Country: France

Facility:
Name: Centre Hospitalier Le Mans

Address:
City: le mans Cedex 9
Zip: 72037
Country: France

Facility:
Name: CHR Hôpital Calmette

Address:
City: Lille CEDEX
Zip: 59037
Country: France

Facility:
Name: CHU Nantes - Hopital Nord Laënnec

Address:
City: NANTES cedex 1
Zip: 44093
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: HIA Begin

Address:
City: Saint Mande
Zip: 94163
Country: France

Facility:
Name: Zentralklinik Bad Berka GmbH

Address:
City: Bad Berka
Zip: 99437
Country: Germany

Facility:
Name: Evangelische Lungenklinik Berlin

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Address:
City: Gauting
Zip: 82131
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: Universitaetsklinikum Koeln

Address:
City: Koeln
Zip: 50937
Country: Germany

Facility:
Name: Kliniken der Stadt Koeln gGmbH

Address:
City: Koeln
Zip: 51109
Country: Germany

Facility:
Name: Bethanien Krankenhaus

Address:
City: Moers
Zip: 47441
Country: Germany

Facility:
Name: Pius-Hospital Oldenburg

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: Oncologianova GmbH

Address:
City: Recklinghausen
Zip: 45659
Country: Germany

Facility:
Name: Orszagos Koranyi Tbc es Pulmonologiai Intezet

Address:
City: Budapest
Zip: H-1529
Country: Hungary

Facility:
Name: Mátrai Gyógyintézet-Bronchológia

Address:
City: Gyöngyös
Zip: 3233
Country: Hungary

Facility:
Name: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Address:
City: Szekesfehervar
Zip: 8000
Country: Hungary

Facility:
Name: Markusovszky Egyetemi Oktatokorhaz

Address:
City: Szombathely
Zip: 9700
Country: Hungary

Facility:
Name: Tudogyogyintezet Torokbalint

Address:
City: Torokbalint
Zip: 2045
Country: Hungary

Facility:
Name: Basavatarakam Indo-American Hospital

Address:
City: Hyderabad
Zip: 500034
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 & Research Centre

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

Facility:
Name: Noble Hospital Pvt Ltd

Address:
City: Pune
Zip: 411013
Country: India

Facility:
Name: Shaare Zedek Medical Center

Address:
City: Jerusalem
Zip: 91031
Country: Israel

Facility:
Name: Hadassah Medical Center

Address:
City: Jerusalem
Zip: 9112001
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: Tel Aviv Sourasky Medical Center

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

Facility:
Name: A O U Sant Orsola Malpighi

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Address:
City: Catania
Zip: 95123
Country: Italy

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

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Address:
City: Milano
Zip: 20122
Country: Italy

Facility:
Name: IRCCS Ospedale San Raffaele

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: San Gerardo Hospital

Address:
City: Monza
Zip: 20052
Country: Italy

Facility:
Name: Ospedale S. Maria Delle Croci

Address:
City: Ravenna
Zip: 48121
Country: Italy

Facility:
Name: Irccs Gemelli

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Istituto Clinico Humanitas

Address:
City: Rozzano
Zip: 20089
Country: Italy

Facility:
Name: Juntendo University Hospital

Address:
City: Bunkyo Ku
Zip: 113 8431
Country: Japan

Facility:
Name: Saitama Medical University International Medical Center

Address:
City: Hidaka
Zip: 350-1298
Country: Japan

Facility:
Name: National Hospital Organization Himeji Medical Center

Address:
City: Himeji
Zip: 670-8520
Country: Japan

Facility:
Name: Kansai Medical University Hospital

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Kanazawa University Hospital

Address:
City: Kanazawa
Zip: 920-8641
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa
Zip: 277 8577
Country: Japan

Facility:
Name: Kishiwada City Hospital

Address:
City: Kishiwada
Zip: 596-8501
Country: Japan

Facility:
Name: Kobe City Medical Center General Hospital

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

Facility:
Name: Kurashiki Central Hospital

Address:
City: Kurashiki
Zip: 710-8602
Country: Japan

Facility:
Name: Kurume University Hospital

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

Facility:
Name: Matsusaka Municipal Hospital

Address:
City: Matsusaka
Zip: 515-8544
Country: Japan

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya Shi
Zip: 464 8681
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: Kindai University Hospital

Address:
City: Osaka Sayama shi
Zip: 589 8511
Country: Japan

Facility:
Name: Kitasato University Hospital

Address:
City: Sagamihara
Zip: 252-0375
Country: Japan

Facility:
Name: Hokkaido University Hospital

Address:
City: Sapporo-shi
Zip: 060-8648
Country: Japan

Facility:
Name: Iwate Medical University Hospital

Address:
City: Shiwa-gun
Zip: 028-3695
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Shizuoka
Zip: 411 8777
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 Yamaguchi Ube Medical Center

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

Facility:
Name: Inje University Haeundae Paik Hospital

Address:
City: Busan
Zip: 48108
Country: Korea, Republic of

Facility:
Name: National Cancer Center

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

Facility:
Name: GyeongSang National University Hospital

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

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Jeollanam-do
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Korea University Anam Hospital

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

Facility:
Name: Kangbuk Samsung Hospital

Address:
City: Seoul
Zip: 03181
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: Hospital Pulau Pinang

Address:
City: George Town
Zip: 10990
Country: Malaysia

Facility:
Name: Hospital Sultan Ismail

Address:
City: Johor Bahru
Zip: 81100
Country: Malaysia

Facility:
Name: Hospital Kuala Lumpur

Address:
City: Kuala Lumpur
Zip: 50586
Country: Malaysia

Facility:
Name: University Malaya Medical Centre

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Facility:
Name: Centro Oncológico de Chihuahua

Address:
City: Chihuahua
Zip: 31217
Country: Mexico

Facility:
Name: Mexico Centre for Clinical Research, S.A. de C.V.

Address:
City: Ciudad de Mexico
Zip: 03100
Country: Mexico

Facility:
Name: Médica Sur

Address:
City: Ciudad de Mexico
Zip: 14050
Country: Mexico

Facility:
Name: Instituto Nacional de Cancerologia

Address:
City: Ciudad de Mexico
Zip: 14080
Country: Mexico

Facility:
Name: Hospital Civil de Guadalajara Fray Antonio Alcalde

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Health Pharma Professional Research

Address:
City: Mexico
Zip: 03100
Country: Mexico

Facility:
Name: i Can Oncology Center

Address:
City: Monterrey
Zip: 64710
Country: Mexico

Facility:
Name: Oncologia Integral Satelite

Address:
City: Naucalpan
Zip: 53100
Country: Mexico

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: 80-214
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: 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: Hosp. Cuf Descobertas

Address:
City: Lisboa
Zip: 1998-018
Country: Portugal

Facility:
Name: Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Address:
City: Lisboa
Zip: G1R 2J6
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: 4200-072
Country: Portugal

Facility:
Name: Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Address:
City: Vila Nova de Gaia
Zip: 4434 502
Country: Portugal

Facility:
Name: Pan American Center for Oncology Trials LLC

Address:
City: Rio Piedras
Zip: 00935
Country: Puerto Rico

Facility:
Name: Irkutsk Regional Oncology Dispensary

Address:
City: Irkutsk
Zip: 664035
Country: Russian Federation

Facility:
Name: Moscow City Oncology Hospital № 62

Address:
City: Krasnogorsk
Zip: 143423
Country: Russian Federation

Facility:
Name: Krasnoyarsk Regional Oncology Dispensary

Address:
City: Krasnoyarsk
Zip: 660133
Country: Russian Federation

Facility:
Name: Leningrad Regional Oncology Dispensary

Address:
City: Kuzmolovsky
Zip: 188663
Country: Russian Federation

Facility:
Name: MCK

Address:
City: Moscow
Zip: 115533
Country: Russian Federation

Facility:
Name: City Clinical Hospital #1

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

Facility:
Name: Nizhny Novgorod Regional Oncological Dispensary

Address:
City: Nizhniy Novgorod
Zip: 603000
Country: Russian Federation

Facility:
Name: N.N. Petrov Research Institute Of Oncology

Address:
City: Saint Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Leningrad Regional Clinical Hospital

Address:
City: Saint-Petersburg
Zip: 194291
Country: Russian Federation

Facility:
Name: Oncology Medical Clinics AV Medical group

Address:
City: St-Petersburg
Zip: 196006
Country: Russian Federation

Facility:
Name: Tomsk Cancer Research Institute

Address:
City: Tomsk
Zip: 634050
Country: Russian Federation

Facility:
Name: Bashkir State Medical University

Address:
City: Ufa
Zip: 450083
Country: Russian Federation

Facility:
Name: Yaroslavl Regional Clinical Oncology Hospital

Address:
City: Yaroslavl
Zip: 150054
Country: Russian Federation

Facility:
Name: Hosp Univ A Coruna

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

Facility:
Name: Inst. Cat. D'Oncologia-Badalona

Address:
City: Badalona
Zip: 08916
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. Univ. de Burgos

Address:
City: Burgos
Zip: 09003
Country: Spain

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

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: Hosp. Univ. Ramon Y Cajal

Address:
City: Madrid
Zip: 28034
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. Pta. de Hierro Majadahonda

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hosp Virgen de La Victoria

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. Clinico Univ. Lozano Blesa

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: Kaohsiung Medical University Chung Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: Chang Gung Medical Foundation

Address:
City: Kaohsiung
Zip: 833
Country: Taiwan

Facility:
Name: Taipei Medical University Shuang Ho Hospital

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

Facility:
Name: Chung Shan Medical University Hospital

Address:
City: Taichung
Zip: 402
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei City
Zip: 10002
Country: Taiwan

Facility:
Name: Phramongkutklao Hospital and Medical College

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Siriraj Hospital

Address:
City: Bangkok
Zip: 10700
Country: Thailand

Facility:
Name: Songklanagarind Hospital, Prince of Songkla University

Address:
City: Songkla
Zip: 90110
Country: Thailand

Facility:
Name: Adana City Hospital

Address:
City: Adana
Zip: 01060
Country: Turkey

Facility:
Name: Başkent University Medical Faculty Adana Application and Research Center

Address:
City: Adana
Zip: 01250
Country: Turkey

Facility:
Name: Gazi University Hospital

Address:
City: Ankara
Zip: 6560
Country: Turkey

Facility:
Name: Ankara Bilkent City Hospital

Address:
City: Ankara
Zip: 6800
Country: Turkey

Facility:
Name: Trakya University Medical Faculty

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

Address:
City: Istanbul
Zip: 34098
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: Izmir Medical Park Hospital

Address:
City: Izmir
Zip: 35580
Country: Turkey

Facility:
Name: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

Address:
City: Dnipro
Zip: 49102
Country: Ukraine

Facility:
Name: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

Address:
City: Kyiv
Zip: 02091
Country: Ukraine

Facility:
Name: National Cancer Institute

Address:
City: Kyiv
Zip: 03022
Country: Ukraine

Facility:
Name: Edinburgh Cancer Centre Western General

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

Facility:
Name: The Royal Marsden NHS Trust

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

Facility:
Name: The Royal Marsden NHS Trust

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Start date: October 13, 2020

Completion date: January 31, 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/NCT04538664