Trial Title:
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT04487080
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Osimertinib
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:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
Only Arm B and C will be masked to all (Double-blind).
Intervention:
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Participants will receive amivantamab intravenously.
Arm group label:
Treatment Arm A (Open-label): Amivantamab and Lazertinib
Other name:
JNJ-61186372
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Participants will receive osimertinib capsules orally.
Arm group label:
Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
Intervention type:
Drug
Intervention name:
Lazertinib
Description:
Participants will receive lazertinib tablets orally.
Arm group label:
Treatment Arm A (Open-label): Amivantamab and Lazertinib
Arm group label:
Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
Other name:
JNJ-73841937 and YH-25448
Intervention type:
Drug
Intervention name:
Placebo
Description:
Participants will receive matching placebo orally.
Arm group label:
Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
Arm group label:
Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
Summary:
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib
combination, compared with osimertinib, in participants with epidermal growth factor
receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution)
positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed description:
Worldwide, lung cancer is the most commonly diagnosed cancer. In NSCLC the most prevalent
actionable driver mutations result in the activation of epidermal growth factor receptor
(EGFR). Osimertinib and Lazertinib are EGFR tyrosine kinase inhibitors (TKIs).
Amivantamab is a novel bispecific antibody that targets the extracellular domain of both
EGFR and MET and can inhibit tumor growth driven by EGFR and mesenchymal-epithelial
transition (MET) receptors. Lazertinib inhibits primary activating Exon 19dell and Exon
21 L858R substitution EGFR mutations, and the EGFR T790M+ resistance mutation. The
hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate
superior PFS compared with single-agent osimertinib (Arm B). The study consists of 3
phases: Screening Phase, Treatment Phase and Follow-up Phase. Participants will undergo
response evaluation criteria in solid tumors (RECIST 1.1), pharmacokinetics, and safety
evaluations (adverse events, laboratory tests, vital sign measurements, physical
examinations).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must have newly diagnosed histologically or cytologically confirmed,
locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment
naive and not amenable to curative therapy including surgical resection or
chemoradiation
- The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as
detected by an food and drug administration (FDA)-approved or other validated test
in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites
in the United states [US]) or an accredited local laboratory (sites outside of the
US) in accordance with site standard of care
- Mandatory submission of unstained tissue from tumor (in a quantity sufficient to
allow for central analysis of EGFR mutation status and blood (for circulating tumor
deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR],
and pharmacogenomic analysis)
- Any toxicities from prior anticancer therapy must have resolved to common
terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
- Participant must have at least 1 measurable lesion, according to response evaluation
criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated.
Measurable lesions should not have been biopsied during screening, but if only 1
non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be
acceptable as a target lesion, provided the baseline tumor assessment scans are
performed at least 14 days after the biopsy
Exclusion Criteria:
- Participant has received any prior systemic treatment at any time for locally
advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy
for Stage I or II disease is allowed, if administered more than 12 months prior to
the development of locally advanced or metastatic disease)
- Participant has an active or past medical history of leptomeningeal disease
- Participant with untreated spinal cord compression. A participant that has been
definitively treated with surgery or radiation and has a stable neurological status
for at least 2 weeks prior to randomization is eligible provided they are off
corticosteroid treatment or receiving low-dose corticosteroid treatment less than or
equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent
- Participant has an active or past medical history of interstitial lung disease
(ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
- Participant has known allergy, hypersensitivity, or intolerance to the excipients
used in formulation of amivantamab, lazertinib, or osimertinib, or any
contraindication to the use of osimertinib
- Participant has symptomatic brain metastases. A participant with asymptomatic or
previously treated and stable brain metastases may participate in this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Associates, PC - HAL
Address:
City:
Goodyear
Zip:
85395
Country:
United States
Facility:
Name:
Yuma Regional Medical Center
Address:
City:
Yuma
Zip:
85364
Country:
United States
Facility:
Name:
City of Hope Long Beach Elm
Address:
City:
Long Beach
Zip:
90813
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:
Lone Tree
Zip:
80124
Country:
United States
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Facility:
Name:
University Cancer And Blood Center LLC
Address:
City:
Athens
Zip:
30607
Country:
United States
Facility:
Name:
East Jefferson General Hospital
Address:
City:
Metairie
Zip:
70006
Country:
United States
Facility:
Name:
Maryland Oncology Hematology, PA
Address:
City:
Columbia
Zip:
21044
Country:
United States
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Minnesota Oncology Hematology P A
Address:
City:
Edina
Zip:
55435
Country:
United States
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Washington University School Of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Facility:
Name:
Willamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Texas Oncology P A
Address:
City:
Austin
Zip:
78745
Country:
United States
Facility:
Name:
Oncology Consultants - Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
Centro Oncológico Korben
Address:
City:
Buenos Aires
Zip:
C1426AGE
Country:
Argentina
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
Buenos Aires
Zip:
C1428ANZ
Country:
Argentina
Facility:
Name:
Hospital Privado Centro Medico de Cordoba
Address:
City:
Cordoba
Zip:
X5016KEH
Country:
Argentina
Facility:
Name:
Centro Oncologico Riojano Integral (Cori)
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Facility:
Name:
Clínica Viedma
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Facility:
Name:
Cabrini Medical Centre
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Facility:
Name:
St John of God Hospital Murdoch
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Facility:
Name:
Southern Medical Day Care Centre
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Facility:
Name:
Cliniques Universitaires Saint Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Facility:
Name:
Grand Hopital de Charleroi, site Notre Dame
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
Clinique Saint Pierre
Address:
City:
Ottignies
Zip:
1340
Country:
Belgium
Facility:
Name:
Algemeen Ziekenhuis Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Facility:
Name:
Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Facility:
Name:
Cetus Oncologia
Address:
City:
Belo Horizonte
Zip:
30110-022
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:
William Osler Health System
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
McGill University Health Centre
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Facility:
Name:
Beijing Friendship Hospital Capital Medical University
Address:
City:
Beijing
Zip:
100050
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:
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:
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:
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:
Nantong Tumor Hospital
Address:
City:
Nantong
Zip:
226300
Country:
China
Facility:
Name:
Ruijin Hospital Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200025
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:
Shengjing Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110022
Country:
China
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Facility:
Name:
Cancer Hospital of Xinjiang Medical University
Address:
City:
Urumchi
Zip:
830000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
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:
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:
CHU de Grenoble Hopital Albert Michallon
Address:
City:
La Tronche
Zip:
38700
Country:
France
Facility:
Name:
Institute Coeur Poumon
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
CHU de Limoges
Address:
City:
Limoges
Zip:
87000
Country:
France
Facility:
Name:
Hopital Nord
Address:
City:
Marseille Cedex 20
Zip:
13915
Country:
France
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Facility:
Name:
Hopital Tenon
Address:
City:
Paris
Zip:
75970
Country:
France
Facility:
Name:
CHU Bordeaux
Address:
City:
Pessac
Zip:
33604
Country:
France
Facility:
Name:
CHU Nantes
Address:
City:
Sain-Herblain
Zip:
44800
Country:
France
Facility:
Name:
HIA Begin
Address:
City:
Saint Mande
Zip:
94163
Country:
France
Facility:
Name:
CHU Bretonneau
Address:
City:
Tours
Zip:
37000
Country:
France
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Facility:
Name:
Zentralklinik Bad Berka GmbH
Address:
City:
Bad Berka
Zip:
99437
Country:
Germany
Facility:
Name:
Helios Klinikum Emil von Behring GmbH
Address:
City:
Berlin
Zip:
14165
Country:
Germany
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Facility:
Name:
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Address:
City:
Halle (Saale)
Zip:
06120
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:
Kliniken der Stadt Koeln gGmbH
Address:
City:
Koeln
Zip:
51109
Country:
Germany
Facility:
Name:
POIS Leipzig GbR
Address:
City:
Leipzig
Zip:
04357
Country:
Germany
Facility:
Name:
Pius-Hospital Oldenburg
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Facility:
Name:
Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Facility:
Name:
Orszagos Koranyi Tbc es Pulmonologiai Intezet
Address:
City:
Budapest
Zip:
H-1529
Country:
Hungary
Facility:
Name:
Veszprém Megyei Tudőgyógyintézet
Address:
City:
Farkasgyepü
Zip:
8582
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:
Noble Hospital Pvt Ltd
Address:
City:
Pune
Zip:
411013
Country:
India
Facility:
Name:
Rambam Health Corporation
Address:
City:
Haifa
Zip:
3109601
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:
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:
Ospedale San Giuseppe Moscati di Avellino
Address:
City:
Avellino
Zip:
83100
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:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Facility:
Name:
San Gerardo Hospital
Address:
City:
Monza
Zip:
20052
Country:
Italy
Facility:
Name:
Ospedale Monaldi
Address:
City:
Napoli
Zip:
80100
Country:
Italy
Facility:
Name:
Aou San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
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:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Zip:
104 0045
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Medical Center
Address:
City:
Fukuoka
Zip:
810-8563
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:
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:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka Sayama shi
Zip:
589 8511
Country:
Japan
Facility:
Name:
National Hospital Organization Shibukawa Medical Center
Address:
City:
Shibukawa
Zip:
377-0280
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135 8550
Country:
Japan
Facility:
Name:
National Hospital Organization Tokyo Medical Center
Address:
City:
Tokyo
Zip:
152 8902
Country:
Japan
Facility:
Name:
Ehime University Hospital
Address:
City:
Toon-shi
Zip:
791-0295
Country:
Japan
Facility:
Name:
National Hospital Organization Osaka Toneyama Medical Center
Address:
City:
Toyonaka-shi
Zip:
560-8552
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:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
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:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
8308
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:
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:
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:
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:
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:
Rijnstate Ziekenhuis
Address:
City:
Arnhem
Zip:
6815 AD
Country:
Netherlands
Facility:
Name:
Ziekenhuis St Jansdal
Address:
City:
Harderwijk
Zip:
3844 DG
Country:
Netherlands
Facility:
Name:
UMC Radboud
Address:
City:
Nijmegen
Zip:
6525AG
Country:
Netherlands
Facility:
Name:
Jeroen Bosch Ziekenhuis
Address:
City:
s-Hertogenbosch
Zip:
5223 GZ
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:
Gdańsk
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:
Uls Santa Maria - Hosp. Pulido Valente
Address:
City:
Lisboa
Zip:
1769-001
Country:
Portugal
Facility:
Name:
Centro Hospitalar Universitario do Porto, EPE
Address:
City:
Porto
Zip:
4099-001
Country:
Portugal
Facility:
Name:
Hospital CUF Porto
Address:
City:
Porto
Zip:
4100 180
Country:
Portugal
Facility:
Name:
Instituto Portugues de Oncologia
Address:
City:
Porto
Zip:
4200-072
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:
Omsk Clinical Oncology Dispensary
Address:
City:
Omsk
Zip:
664013
Country:
Russian Federation
Facility:
Name:
Current medical technologies
Address:
City:
Saint Petersburg
Zip:
190121
Country:
Russian Federation
Facility:
Name:
N.N. Petrov Research Institute Of Oncology
Address:
City:
Saint Petersburg
Zip:
197758
Country:
Russian Federation
Facility:
Name:
Oncology Medical Clinics AV Medical group
Address:
City:
St-Petersburg
Zip:
196006
Country:
Russian Federation
Facility:
Name:
Tambov Regional Oncology Clinical Dispansary
Address:
City:
Tambov
Zip:
392013
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:
Institut Català D'Oncologia Girona
Address:
City:
Girona
Zip:
17007
Country:
Spain
Facility:
Name:
Hosp. Gral. Univ. Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
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 Regional Univ de Malaga
Address:
City:
Malaga
Zip:
29011
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. 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:
E-DA Hospital
Address:
City:
Kaohsiung
Zip:
824
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 Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
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:
Chiang Mai University
Address:
City:
Chiangmai
Zip:
50200
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:
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Facility:
Name:
Medical Point
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Facility:
Name:
Necmettin Erbakan University Meram Medical Faculty
Address:
City:
Konya
Zip:
42080
Country:
Turkey
Facility:
Name:
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Address:
City:
Dnipro
Zip:
49102
Country:
Ukraine
Facility:
Name:
Municipal non-profit enterprise 'Regional Center of Oncology'
Address:
City:
Kharkiv
Zip:
61070
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:
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Address:
City:
Uzhgorod
Zip:
88000
Country:
Ukraine
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:
Chelsea And Westminster Hospital
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Facility:
Name:
The Royal Marsden NHS Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Facility:
Name:
Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Facility:
Name:
The Royal Marsden NHS Trust
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Start date:
September 30, 2020
Completion date:
June 29, 2027
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/NCT04487080
