Trial Title:
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
NCT ID:
NCT05498428
Condition:
Carcinoma, Non-small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Amivantamab-vmjw
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Anticoagulants
Lazertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Amivantamab will be administered subcutaneously by manual injection.
Arm group label:
Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib
Arm group label:
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Arm group label:
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Arm group label:
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Arm group label:
Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)
Arm group label:
Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib
Arm group label:
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Arm group label:
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Other name:
JNJ-61186372
Intervention type:
Drug
Intervention name:
Lazertinib
Description:
Lazertinib will be administered as an oral tablet.
Arm group label:
Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib
Arm group label:
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Arm group label:
Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib
Arm group label:
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Other name:
JNJ-73841937; YH25448
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin will be administrated by IV infusion.
Arm group label:
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Arm group label:
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Arm group label:
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Arm group label:
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed will be administered by IV infusion.
Arm group label:
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Arm group label:
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Arm group label:
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Arm group label:
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Intervention type:
Drug
Intervention name:
Direct Oral Anticoagulant (DOAC)
Description:
DOAC will be administered orally.
Arm group label:
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Intervention type:
Drug
Intervention name:
Low Molecular Weight Heparin (LMWH)
Description:
LMWH will be administered subcutaneously.
Arm group label:
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Summary:
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed, locally advanced or
metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative
therapy including surgical resection or chemoradiation. Additional Cohort specific
disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor
receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2:
EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any
prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2:
Participant should not have received any prior systemic therapy for locally advanced
or metastatic NSCLC. Cohorts 3and3b: 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. Cohort
4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or
1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an
expanded access program, or as a rollover from a long-term extension, without any
amivantamab dose reduction. Cohort 7: Participants must have progressed on or after
the combination of amivantamab and lazertinib as the most recent line of treatment.
The combination of amivantamab and lazertinib must have been administered as the
first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b,
and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as
determined by Food and Drug Administration (FDA) approved or other validated test of
either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue 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). A copy of
the initial test report documenting the EGFR mutation must be included in the
participant records and a deidentified copy must also be submitted to the sponsor
- All cohorts except Cohort 4: Participants must have at least 1 measurable lesion,
according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If
the only target lesion has been previously irradiated, it must show signs of disease
progression since radiation was completed If only 1 non-irradiated measurable lesion
exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline
tumor assessment scans should be performed at least 14 days after the biopsy
- May have a prior or concurrent second malignancy (other than the disease under
study) which natural history or treatment is unlikely to interfere with any study
endpoints of safety or the efficacy of the study treatment(s)
- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac)
functions
- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
- Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic
anticoagulation with a direct oral anticoagulant or a low molecular weight heparin
during the first 4 months of study treatment
- A participant must agree not to donate eggs (ova, oocytes) or freeze for future use
for the purposes of assisted reproduction during the study and for a period of 6
months after receiving the last dose of study treatment. Female participants should
consider preservation of eggs prior to study treatment as anti-cancer treatments may
impair fertility
Exclusion Criteria:
- Participant has a medical history of interstitial lung disease (ILD), including drug
induced ILD or radiation pneumonitis
- Participant has a history of hypersensitivity to any excipients of the
investigational products to be used in their enrollment cohort
- Participant has received a live or live attenuated vaccine within 3 months before
Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against
Coronavirus disease 19 (COVID-19) are not exclusionary
- For all cohorts (with regimens potentially including lazertinib): Participant is
currently receiving medications or herbal supplements known to be potent Cytochrome
(CYP3A4/5) inducers and is unable to stop use for an appropriate washout period
prior to Cycle 1 Day 1
- Other clinically active liver disease of infectious origin
- Participant has a history of clinically significant cardiovascular disease
including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or
pulmonary embolism within 1 month prior to the first dose of study treatment(s), or
any of the following within 6 months prior to the first dose of study treatment(s):
myocardial infarction, unstable angina, stroke, transient ischemic attack,
coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically
non-significant thrombosis, such as non-obstructive catheter-associated clots, are
not exclusionary; b) All cohorts (with regimens potentially including lazertinib):
Participant has a significant genetic predisposition to venous thromboembolic events
(VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including
lazertinib): Participant has a prior history of VTE and is not on appropriate
therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected
QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec)
or clinically significant cardiac arrhythmia or electrophysiologic disease (example,
placement of implantable cardioverter defibrillator or atrial fibrillation with
uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood
pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg;
f) Congestive heart failure defined as NYHA class III-IV or hospitalization for
congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within
6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically
significant pericardial effusion; h) myocarditis; i) baseline left ventricular
ejection fraction (LVEF) below the institution's lower limit of normal at screening,
as assessed by echocardiogram or multigated acquisition (MUGA) scan
- Participant has symptomatic brain metastases. A participant with asymptomatic or
previously treated and stable brain metastases may participate in this study.
Participants who have received definitive radiation or surgical treatment for
symptomatic or unstable brain metastases and have been clinically stable and
asymptomatic for at least 2 weeks before Screening are eligible, provided they have
been either off corticosteroid treatment or are receiving low-dose corticosteroid
treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or
equivalent) for at least 2 weeks prior to treatment allocation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California at San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Lynn Cancer Institute
Address:
City:
Boca Raton
Zip:
33486
Country:
United States
Status:
Completed
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Facility:
Name:
AdventHealth
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Facility:
Name:
H. Lee Moffitt Cancer & Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Boston Medical Center
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School Of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Hemotology Oncology Associates of CNY
Address:
City:
East Syracuse
Zip:
13057
Country:
United States
Status:
Completed
Facility:
Name:
Novant Health
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
Novant Health
Address:
City:
Winston-Salem
Zip:
27106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44111
Country:
United States
Status:
Completed
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Completed
Facility:
Name:
Cleveland Clinic
Address:
City:
Mayfield Heights
Zip:
44124
Country:
United States
Status:
Completed
Facility:
Name:
Cleveland Clinic
Address:
City:
Warrensville Heights
Zip:
44122
Country:
United States
Status:
Completed
Facility:
Name:
The Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Regional Cancer Partnership
Address:
City:
Everett
Zip:
98201
Country:
United States
Status:
Completed
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Completed
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Facility:
Name:
Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
PERSONAL Oncologia de Precisao e Personalizada
Address:
City:
Belo Horizonte
Zip:
30130 090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto do Cancer de Londrina Hospital do Cancer de Londrina
Address:
City:
Londrina
Zip:
86015
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Associacao Hospitalar Moinhos de Vento
Address:
City:
Porto Alegre
Zip:
90035-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto D Or de Pesquisa e Ensino IDOR
Address:
City:
Rio de Janeiro
Zip:
22281 100
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto D Or de Pesquisa e Ensino IDOR
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Alemao Oswaldo Cruz
Address:
City:
Sao Paulo
Zip:
01327 001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Impar Servicos Hospitalares SA Hospital Nove de Julho
Address:
City:
Sao Paulo
Zip:
01409-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Zip:
71000
Country:
China
Status:
Recruiting
Facility:
Name:
Jilin cancer hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610047
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of PLA Army Medical University
Address:
City:
ChongQing
Zip:
400038
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Sun Yat sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Zhejiang University College of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Huizhou
Zip:
516001
Country:
China
Status:
Recruiting
Facility:
Name:
Liuzhou people's Hospital
Address:
City:
Liuzhou
Zip:
545006
Country:
China
Status:
Completed
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Facility:
Name:
Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214122
Country:
China
Status:
Completed
Facility:
Name:
The First Affiliated Hospital of Xian Jiaotong University
Address:
City:
XI An
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264000
Country:
China
Status:
Completed
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen Cedex 05
Zip:
14076
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Completed
Facility:
Name:
Institut de Cancérologie du Gard
Address:
City:
Nîmes
Zip:
30029
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
PARIS Cedex 5
Zip:
75248
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de cancerologie de l'ouest
Address:
City:
Saint-Herblain Cedex
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Evangelische Lungenklinik Berlin
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Completed
Facility:
Name:
LungenClinic Grosshansdorf GmbH
Address:
City:
Grosshandorf
Zip:
22927
Country:
Germany
Status:
Recruiting
Facility:
Name:
Lungenfachklinik Immenhausen
Address:
City:
Immenhausen
Zip:
34376
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Koelnt
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Address:
City:
Wuerzburg
Zip:
97074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
91031
Country:
Israel
Status:
Recruiting
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar Saba
Zip:
44281
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Status:
Recruiting
Facility:
Name:
Policlinico Hospital San Martino- IRCCS for Oncology
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera San Gerardo
Address:
City:
Monza
Zip:
20090
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Specialistica dei Colli
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Hospital Organization Himeji Medical Center
Address:
City:
Himeji
Zip:
670-8520
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Matsusaka Municipal Hospital
Address:
City:
Matsusaka
Zip:
515-8544
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Shizuoka
Zip:
411 8777
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135 8550
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama
Zip:
641 8510
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-Si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Tengku Ampuan Afzan
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Umum Sarawak
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Beacon Hospital Sdn Bhd
Address:
City:
Petaling Jaya
Zip:
46050
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hosp Univ A Coruna
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
General University Hospital of Alicantet
Address:
City:
Alacant
Zip:
03010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. de La Santa Creu I Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Inst. Cat. Doncologia-H Duran I Reynals
Address:
City:
Barcelona
Zip:
8908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Regional Univ de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Clinico Univ. de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Cheltenham General Hospital
Address:
City:
Cheltenham
Zip:
GL53 7AN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Torbay Hospital-Devon
Address:
City:
Devon
Zip:
TQ2 7AA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Edinburgh Cancer Centre Western General
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University College London Hospitals
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Nottingham City Hospital
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Queen Alexandra Hospital
Address:
City:
Portsmouth
Zip:
PO6 3LY
Country:
United Kingdom
Status:
Recruiting
Start date:
November 11, 2022
Completion date:
August 5, 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/NCT05498428
