Trial Title:
Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
NCT ID:
NCT05609968
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Sacituzumab govitecan
Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death-2 (PD2, PD-2)
Programmed Death-Ligand 2 (PDL2, PD-L2)
Trophoblast Cell Surface Antigen-2 (TROP-2)
Antibody-Drug Conjugate (ADC)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Sacituzumab Govitecan
Description:
IV infusion
Arm group label:
Pembrolizumab + Sacituzumab Govitecan
Other name:
Trodelvy®
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV infusion
Arm group label:
Pembrolizumab
Arm group label:
Pembrolizumab + Sacituzumab Govitecan
Other name:
MK-3475
Other name:
Keytruda®
Summary:
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with
sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival
(PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults
with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1
(PD-L1) tumor proportion score (TPS) ≥50%).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has a histologically or cytologically confirmed diagnosis of metastatic non-small
cell lung cancer (NSCLC)
- Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma
kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated
as primary therapy
- Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50%
of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has a life expectancy of at least 3 months
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 3 years
- Has received prior systemic chemotherapy or other targeted or biological
antineoplastic therapy for their metastatic NSCLC
- Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted
therapy
- Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1),
anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell
death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or
coinhibitory T-cell receptor
- Has received prior radiotherapy within 2 weeks of start of study intervention or has
radiation-related toxicities requiring corticosteroids
- Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of
the first dose of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention
- Has received an investigational agent or has used an investigational device within 4
weeks before study intervention administration
- Has cardiac disease
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment
- History of serious ventricular arrhythmia, high-grade atrioventricular block,
or other cardiac arrhythmias requiring antiarrhythmic medications; history of
QT interval prolongation
- New York Heart Association (NYHA) Class III or greater congestive heart failure
or left ventricular ejection fraction of <40%
- Has active chronic inflammatory bowel disease
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior the first dose of
study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan
and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in past 2 years
except replacement therapy
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has history of human immunodeficiency virus (HIV) infection
- History of hepatitis B or known active hepatitis C virus infection
- Has history or current evidence of any condition, therapy, laboratory abnormality,
or other circumstance that might confound the results of the study or interfere with
the participant's participation for the full duration of the study, such that it is
not in the best interest of the participant to participate, in the opinion of the
treating investigator
- Have not adequately recovered from major surgery or have ongoing surgical
complications
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Infirmary Cancer Care ( Site 0418)
Address:
City:
Mobile
Zip:
36607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
251-435-2273
Facility:
Name:
Clermont Oncology Center ( Site 0421)
Address:
City:
Clermont
Zip:
34711
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
352-242-1366
Facility:
Name:
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
305-689-0974
Facility:
Name:
Mid Florida Hematology and Oncology Center ( Site 0416)
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
407-353-1915
Facility:
Name:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
770-281-5100
Facility:
Name:
Our Lady of the Lake RMC ( Site 0424)
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
225-765-3344
Facility:
Name:
Henry Ford Hospital ( Site 0412)
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
313-725-7636
Facility:
Name:
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
651-241-7025
Facility:
Name:
White Plains Hospital-Center for Cancer Care ( Site 0403)
Address:
City:
White Plains
Zip:
10601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
914-849-7630
Facility:
Name:
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
503-249-3315
Facility:
Name:
Houston Methodist Hospital ( Site 0419)
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
646-407-2086
Facility:
Name:
Central Texas Veterans health care ( Site 0414)
Address:
City:
Temple
Zip:
76504
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
254-346-1010
Facility:
Name:
Orange Hospital-Clinical Trials Unit ( Site 0600)
Address:
City:
Orange
Zip:
2800
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61263693380
Facility:
Name:
Cancer Research SA-St Andrews Hospital ( Site 0603)
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+6183592565
Facility:
Name:
Frankston Hospital-Oncology and Haematology ( Site 0601)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0397848562
Facility:
Name:
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)
Address:
City:
Fortaleza
Zip:
60336232
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5585999845814
Facility:
Name:
Hospital Tacchini ( Site 0322)
Address:
City:
Bento Goncalves
Zip:
95700-068
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
555434554333
Facility:
Name:
Hospital da Cidade de Passo Fundo ( Site 0321)
Address:
City:
Passo Fundo
Zip:
99010-260
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
55 54 981271411
Facility:
Name:
Instituto de Oncologia Saint Gallen ( Site 0317)
Address:
City:
Santa Cruz do Sul
Zip:
96830-180
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5551991898942
Facility:
Name:
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)
Address:
City:
Barretos
Zip:
14784400
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
551733216637
Facility:
Name:
A. C. Camargo Cancer Center ( Site 0324)
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5511993607754
Facility:
Name:
BC Cancer Abbotsford-Medical Oncology ( Site 0433)
Address:
City:
Abbotsford
Zip:
V2S 0C2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6048514710644741
Facility:
Name:
Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)
Address:
City:
Newmarket
Zip:
L3Y 2P9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905-895-4521 ext 5155
Facility:
Name:
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)
Address:
City:
Greenfield Park
Zip:
J4V 2H1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
45046650002696
Facility:
Name:
St. Marys Hospital Center-Oncology ( Site 0434)
Address:
City:
Montreal
Zip:
H3T 1M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5148916904
Facility:
Name:
Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)
Address:
City:
Trois-Rivières
Zip:
G8Z 3R9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8196973333
Facility:
Name:
Oncovida ( Site 0334)
Address:
City:
Santiago
Zip:
7510032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5624205100
Facility:
Name:
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332)
Address:
City:
Santiago
Zip:
8330032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56963413803
Facility:
Name:
Second Affiliated hospital of Anhui Medical University ( Site 0126)
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13865952007
Facility:
Name:
Anhui Provincial Hospital ( Site 0136)
Address:
City:
Hefei
Zip:
230071
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613805695536
Facility:
Name:
Beijing Cancer hospital ( Site 0104)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613521469355
Facility:
Name:
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13911235467
Facility:
Name:
Beijing Chest Hospital,Capital Medical University ( Site 0105)
Address:
City:
Beijing
Zip:
101149
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
861089500153
Facility:
Name:
Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
02365075648
Facility:
Name:
Fujian Provincial Cancer Hospital ( Site 0131)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613313786157
Facility:
Name:
The First Affiliated hospital of Xiamen University ( Site 0132)
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13860458889
Facility:
Name:
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
020-61641575
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 0113)
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86 13977183708
Facility:
Name:
Harbin Medical University Cancer Hospital ( Site 0119)
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13904505825
Facility:
Name:
Henan Cancer Hospital ( Site 0127)
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
037165587418
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86 13212760751
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)
Address:
City:
Wuhan
Zip:
430010
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13871244098
Facility:
Name:
Hubei Cancer Hospital ( Site 0107)
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613886048178
Facility:
Name:
Xiangya Hospital Central South University ( Site 0124)
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13874808039
Facility:
Name:
The Second Xiangya Hospital of Central South University ( Site 0135)
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13975806788
Facility:
Name:
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112
Address:
City:
NanJing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13813920964
Facility:
Name:
Nantong Tumor Hospital-Medical Oncology ( Site 0122)
Address:
City:
Nantong
Zip:
226361
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13814603295
Facility:
Name:
The First Affliated Hospital of Suzhou University ( Site 0114)
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613506218900
Facility:
Name:
The Second Affiliated Hospital of Nanchang University ( Site 0134)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613767120022
Facility:
Name:
The First Hospital of Jilin University ( Site 0117)
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8615843073215
Facility:
Name:
Jilin Province Tumor Hospital ( Site 0118)
Address:
City:
Changchun
Zip:
132000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613943012851
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613572101611
Facility:
Name:
Jinan Central Hospital-oncology department ( Site 0121)
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0531-55739999
Facility:
Name:
LinYi Cancer Hospital ( Site 0120)
Address:
City:
Linyi
Zip:
276001
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 15963998868
Facility:
Name:
Shanghai Chest Hospital ( Site 0101)
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613601813062
Facility:
Name:
Fudan University Shanghai Cancer Center-Oncology ( Site 0102)
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613501623469
Facility:
Name:
Huashan Hospital, Fudan University ( Site 0103)
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13816718958
Facility:
Name:
West China Hospital of Sichuan University ( Site 0129)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8618980602257
Facility:
Name:
Sichuan Cancer hospital ( Site 0128)
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18908178836
Facility:
Name:
The First Affiliated Hospital, Zhejiang University ( Site 0109)
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
861082265511
Facility:
Name:
Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8618329059962
Facility:
Name:
Zhejiang Cancer Hospital ( Site 0108)
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8657188122188
Facility:
Name:
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)
Address:
City:
Hangzhou
Zip:
310052
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613251011733
Facility:
Name:
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)
Address:
City:
Tallinn
Zip:
13419
Country:
Estonia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3726171792
Facility:
Name:
Tartu University Hospital-Radiotherapy and oncology ( Site 0620)
Address:
City:
Tartu
Zip:
50406
Country:
Estonia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
003725549105
Facility:
Name:
Universitätsmedizin Mannheim ( Site 0654)
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0049 6213831755
Facility:
Name:
Klinikum Kempten ( Site 0655)
Address:
City:
Kempten
Zip:
87439
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
49 831 530 2382
Facility:
Name:
Klinikum Würzburg Mitte ( Site 0651)
Address:
City:
Wuerzburg
Zip:
97074
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
499317912811
Facility:
Name:
Katholisches Klinikum Koblenz ( Site 0650)
Address:
City:
Koblenz
Zip:
56073
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
02614964095
Facility:
Name:
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
493455591440
Facility:
Name:
Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- (
Address:
City:
Berlin
Zip:
13585
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4930130132601
Facility:
Name:
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)
Address:
City:
Berlin
Zip:
14165
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00493081021447
Facility:
Name:
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)
Address:
City:
Athens
Zip:
115 26
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+306983519989
Facility:
Name:
Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 014
Address:
City:
Athens
Zip:
115 27
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
302107700220
Facility:
Name:
European Interbalkan Medical Center-Oncology Department ( Site 0142)
Address:
City:
Thessaloniki
Zip:
57001
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
306942608228
Facility:
Name:
Shaare Zedek Medical Center-Oncology ( Site 0176)
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+972587040620
Facility:
Name:
Meir Medical Center-oncology ( Site 0171)
Address:
City:
KfarSaba
Zip:
4428164
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97297472414
Facility:
Name:
Rabin Medical Center-Oncology ( Site 0174)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+ 9729378101
Facility:
Name:
Sourasky Medical Center-Oncology ( Site 0175)
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+972 36973494
Facility:
Name:
Yitzhak Shamir Medical Center. ( Site 0179)
Address:
City:
Zerifin
Zip:
70300
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+9723-5307928
Facility:
Name:
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)
Address:
City:
Roma
Zip:
00185
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
393476063165
Facility:
Name:
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 035 267 4660
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390223903829
Facility:
Name:
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0817062652
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0039 0557947298
Facility:
Name:
Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)
Address:
City:
Peschiera del Garda
Zip:
37019
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0456444843
Facility:
Name:
Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390521702682
Facility:
Name:
Aichi Cancer Center Hospital ( Site 0018)
Address:
City:
Nagoya
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81527626111
Facility:
Name:
National Hospital Organization Shikoku Cancer Center ( Site 0008)
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81899991111
Facility:
Name:
Kurume University Hospital ( Site 0014)
Address:
City:
Kurume
Zip:
830-0011
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81942353311
Facility:
Name:
Takarazuka City Hospital ( Site 0015)
Address:
City:
Takarazuka
Zip:
665-0827
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81797871161
Facility:
Name:
Kanazawa University Hospital ( Site 0019)
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81762652000
Facility:
Name:
Kanagawa cancer center ( Site 0016)
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81455202222
Facility:
Name:
Miyagi Cancer Center ( Site 0001)
Address:
City:
Natori
Zip:
981-1293
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81223843151
Facility:
Name:
Sendai Kousei Hospital ( Site 0012)
Address:
City:
Sendai
Zip:
981-0914
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-22-728-8000
Facility:
Name:
Niigata Cancer Center Hospital ( Site 0017)
Address:
City:
Niigata-shi
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81252665111
Facility:
Name:
Kurashiki Central Hospital ( Site 0011)
Address:
City:
Kurashiki
Zip:
710-8602
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81864220210
Facility:
Name:
Kansai Medical University Hospital ( Site 0005)
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81728040101
Facility:
Name:
Kindai University Hospital- Osakasayama Campus ( Site 0013)
Address:
City:
Osaka-sayama
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81723660221
Facility:
Name:
Saitama Prefectural Cancer Center ( Site 0002)
Address:
City:
Ina-machi
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81487221111
Facility:
Name:
Shizuoka Cancer Center ( Site 0004)
Address:
City:
Nagaizumi-cho,Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81559895222
Facility:
Name:
National Hospital Organization Kyushu Medical Center ( Site 0009)
Address:
City:
Fukuoka
Zip:
810-8563
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81928520700
Facility:
Name:
Kyushu University Hospital ( Site 0010)
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81926411151
Facility:
Name:
Okayama University Hospital ( Site 0007)
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81862237151
Facility:
Name:
Nippon Medical School Hospital ( Site 0003)
Address:
City:
Tokyo
Zip:
113-8603
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81338222131
Facility:
Name:
Wakayama Medical University Hospital ( Site 0006)
Address:
City:
Wakayama
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81734472300
Facility:
Name:
Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-61-379-7614
Facility:
Name:
Pusan National University Yangsan Hospital ( Site 0060)
Address:
City:
Busan
Zip:
50612
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-55-360-4764
Facility:
Name:
Chungnam national university hospital-Department of Internal Medicine ( Site 0063)
Address:
City:
Daejeon
Zip:
35015
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-042-280-8035
Facility:
Name:
Asan Medical Center ( Site 0064)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-2-3010-5902
Facility:
Name:
Korea University Guro Hospital-Internal Medicine ( Site 0062)
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-2-2626-1914
Facility:
Name:
Daugavpils Regional Hospital-Oncology Department ( Site 0194)
Address:
City:
Daugavpils
Zip:
5417
Country:
Latvia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37126896160
Facility:
Name:
Liepjas reionl slimnca ( Site 0191)
Address:
City:
Liepaja
Zip:
LV-3414
Country:
Latvia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37126351999
Facility:
Name:
Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)
Address:
City:
Riga
Zip:
LV1002
Country:
Latvia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37126467368
Facility:
Name:
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch
Address:
City:
Riga
Zip:
LV1079
Country:
Latvia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37126594570
Facility:
Name:
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)
Address:
City:
Kaunas
Zip:
50161
Country:
Lithuania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37037326457
Facility:
Name:
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 0691)
Address:
City:
Vilnius
Zip:
08660
Country:
Lithuania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
37052786748
Facility:
Name:
Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)
Address:
City:
Kota Bharu
Zip:
15586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0199179838
Facility:
Name:
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)
Address:
City:
George Town
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+60124931319
Facility:
Name:
Beacon Hospital Sdn Bhd ( Site 0033)
Address:
City:
Petaling Jaya
Zip:
46050
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
60126210140
Facility:
Name:
Clinica Vallesur - AUNA ( Site 0360)
Address:
City:
Arequipa
Zip:
04001
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+51959665164
Facility:
Name:
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)
Address:
City:
Concepcion
Zip:
12125
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+51958864658
Facility:
Name:
Centro de investigacion Clínica Trujillo ( Site 0358)
Address:
City:
Trujillo
Zip:
13001
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5044-204942
Facility:
Name:
Detecta Clínica ( Site 0364)
Address:
City:
Surquillo
Zip:
15038
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+51967665031
Facility:
Name:
Clínica Internacional - Sede San Borja ( Site 0356)
Address:
City:
Lima
Zip:
15036
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+51 6196161 ext. 7717
Facility:
Name:
Hospital Cayetano Heredia ( Site 0361)
Address:
City:
Lima
Zip:
15102
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
51984396979
Facility:
Name:
Metro Davao Medical and Research Center ( Site 0047)
Address:
City:
Davao City
Zip:
8000
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+639177005968
Facility:
Name:
ST. LUKE'S MEDICAL CENTER ( Site 0046)
Address:
City:
Quezon City
Zip:
1102
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
09285030641
Facility:
Name:
Cebu Doctors University Hospital ( Site 0045)
Address:
City:
Cebu
Zip:
6000
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
639209277308
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48501446778
Facility:
Name:
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)
Address:
City:
Siedlce
Zip:
08-110
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48698826497
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48225463066
Facility:
Name:
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
661957237
Facility:
Name:
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)
Address:
City:
Prabuty
Zip:
82-550
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48503022396
Facility:
Name:
Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)
Address:
City:
Racibórz
Zip:
47-400
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48600988517
Facility:
Name:
Med-Polonia Sp. z o. o. ( Site 0204)
Address:
City:
Poznan
Zip:
60-693
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48618549040
Facility:
Name:
Gral Medical SRL-Medical Oncology ( Site 0220)
Address:
City:
București
Zip:
031422
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40726273762
Facility:
Name:
Cardiomed SRL Cluj-Napoca ( Site 0217)
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0040724543672
Facility:
Name:
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)
Address:
City:
Florești
Zip:
407280
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40742206212
Facility:
Name:
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 0215)
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40727774974
Facility:
Name:
Cabinet Medical Oncomed ( Site 0219)
Address:
City:
Timișoara
Zip:
300239
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40744571617
Facility:
Name:
Institutul Oncologic-Oncologie Medicala ( Site 0218)
Address:
City:
Cluj
Zip:
400015
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40745646368
Facility:
Name:
Chung Shan Medical University Hospital ( Site 0078)
Address:
City:
Taichung City
Zip:
402
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+886-4-2473-9595
Facility:
Name:
National Taiwan University Cancer Center (NTUCC) ( Site 0079)
Address:
City:
Taipei City
Zip:
106
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
88622312345667511
Facility:
Name:
E-Da hospital ( Site 0075)
Address:
City:
Kaohsiung
Zip:
82445
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+886-7-615-0011
Facility:
Name:
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+886-6-235-3535
Facility:
Name:
National Taiwan University Hospital-Internal Medicine ( Site 0080)
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
88622312345662905
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch ( Site 0082)
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
886332812008468
Facility:
Name:
Maharaj Nakorn Chiang Mai Hospital ( Site 0092)
Address:
City:
Muang
Zip:
50200
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6653935480
Facility:
Name:
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)
Address:
City:
Bangkok
Zip:
10300
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+66816845172
Facility:
Name:
Faculty of Medicine Siriraj Hospital ( Site 0090)
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6624194488
Facility:
Name:
Lampang Cancer Hospital ( Site 0098)
Address:
City:
Mueang Lampang
Zip:
52000
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0818830898
Facility:
Name:
Songklanagarind hospital ( Site 0091)
Address:
City:
Hatyai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6674451469
Facility:
Name:
Sunpasitthiprasong Hospital ( Site 0093)
Address:
City:
Ubon Ratchathani
Zip:
34000
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6622011671
Facility:
Name:
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+905334318506
Facility:
Name:
Liv Hospital Ankara-Oncology ( Site 0274)
Address:
City:
Ankara
Zip:
06680
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905056604536
Facility:
Name:
Ankara City Hospital-Medical Oncology ( Site 0268)
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905555306271
Facility:
Name:
Trakya University-Medical Oncology ( Site 0270)
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905326845953
Facility:
Name:
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267)
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00905063509061
Facility:
Name:
VM Medical Park Pendik Hospital ( Site 0271)
Address:
City:
Istanbul
Zip:
34899
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+905052014666
Facility:
Name:
I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+905054790614
Facility:
Name:
Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)
Address:
City:
Mersin
Zip:
33240
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+905458259095
Facility:
Name:
University College London Hospital ( Site 0305)
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+44 (0)20 3456 7890
Facility:
Name:
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+44 (0)300 303 1573
Facility:
Name:
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+44 (0)20 7377 7000
Facility:
Name:
The Clatterbridge Cancer Centre ( Site 0303)
Address:
City:
Wirral
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+44 (0)151 556 5000
Start date:
February 6, 2023
Completion date:
August 23, 2028
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609968
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-D46&kw=3475-D46
