Trial Title:
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
NCT ID:
NCT06312137
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Pemetrexed
Conditions: Keywords:
Carcinoma, Lung cancer, non small cell lung cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a multi site study
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Sacituzumab tirumotecan
Description:
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 40 weeks
Arm group label:
Pembrolizumab + Sacituzumab tirumotecan
Other name:
MK-2870
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Arm group label:
Pembrolizumab
Arm group label:
Pembrolizumab + Sacituzumab tirumotecan
Other name:
MK-3475
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background
treatment in neoadjuvant phase
Arm group label:
Pembrolizumab
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for
up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
Arm group label:
Pembrolizumab
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV
infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in
participants with squamous NSCLC.
Arm group label:
Pembrolizumab
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6
mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
Arm group label:
Pembrolizumab
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV
infusion q3w for up to 12 weeks as background treatment.
Arm group label:
Pembrolizumab
Summary:
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery
is effective in treating NSCLC for participants not achieving pathological complete
response. The primary hypothesis of this study is sacituzumab tirumotecan plus
pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free
survival (DFS) as assessed by blinded independent central review (BICR).
Criteria for eligibility:
Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has histological or cytological confirmation of squamous or nonsquamous non-small
cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal
involvement [N2]) per AJCC eighth edition guidelines.
- Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is
not indicated as primary therapy.
- Is able to undergo surgery based on opinion of investigator after consultation with
surgeon.
- Is able to receive neoadjuvant pembrolizumab and platinum-based doublet
chemotherapy.
- Applies to screening for the adjuvant period only, before randomization: Has not
achieved pathological complete response (pCR) at surgery by local review of
pathology.
- Applies to screening for the adjuvant period only, before randomization: Tumor
tissue sample from surgical resection has been provided for determination of
programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2
(TROP2) status by central vendor before randomization into the adjuvant period.
- Applies to screening for the adjuvant period only, before randomization: Confirmed
to be disease-free based on re-baseline radiological assessment as documented by
contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic
resonance imaging (MRI)) within 28 days before randomization.
- Participants who have AEs due to previous anticancer therapies must have recovered
to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately
treated with hormone replacement are eligible.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if
they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,
and have undetectable HBV viral load at screening.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at least 4 weeks before the start of study intervention.
Exclusion Criteria:
- Has one of the following tumor locations/types:
- NSCLC involving the superior sulcus
- Large cell neuro-endocrine cancer (LCNEC)
- Sarcomatoid tumor
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
- Documentation by local test report indicating presence of anaplastic lymphoma
kinase (ALK) gene rearrangements
- Has Grade ≥2 peripheral neuropathy.
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease
and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease,
including New York Heart Association Class III or IV congestive heart failure,
unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia,
prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF)
interval to >480 ms, and/or other serious cardiovascular and cerebrovascular
diseases within the 6 months preceding study intervention.
- Has received prior neoadjuvant therapy for their current NSCLC diagnosis.
- Has received prior systemic anticancer therapy including investigational agents
within 4 weeks before the first dose of study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention, or
radiation-related toxicities, requiring corticosteroids.
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study medication.
- Has a known additional malignancy that is progressing or has required active
treatment within the past 5 years.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Is an HIV-infected participant with a history of Kaposi's sarcoma and/or
Multicentric Castleman's Disease.
- Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV
deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody
(Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.
- Has a severe hypersensitivity (Grade ≥3) to sacituzumab tirumotecan, any of its
excipients and/or to another biologic therapy.
- Has a history of allogeneic tissue/solid organ transplant.
- Has 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:
Mount Sinai Cancer Center ( Site 0038)
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
305-674-2625
Facility:
Name:
Mid Florida Hematology and Oncology Center ( Site 0018)
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
407-353-1915
Facility:
Name:
Centricity Research Columbus Cancer Center ( Site 0005)
Address:
City:
Columbus
Zip:
31904
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
706-660-6449
Facility:
Name:
Archbold Cancer Center ( Site 0071)
Address:
City:
Thomasville
Zip:
31792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
229-584-5400
Facility:
Name:
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
Address:
City:
Elmhurst
Zip:
60126
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
630-527-3788
Facility:
Name:
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
Address:
City:
Naperville
Zip:
60540
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
630-646-2273
Facility:
Name:
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
651-241-7025
Facility:
Name:
Mercy Research - David C. Pratt Cancer Center ( Site 0006)
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
314-251-7057
Facility:
Name:
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
775-982-3890
Facility:
Name:
Stony Brook University-Cancer Center ( Site 0054)
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
631-444-2296
Facility:
Name:
Millennium Research & Clinical Development ( Site 0039)
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
281-440-5006
Facility:
Name:
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
Address:
City:
Caba
Zip:
C1199ABB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
541149590200 8159
Facility:
Name:
Hospital Británico de Buenos Aires-Oncology ( Site 0207)
Address:
City:
Ciudad autónoma de Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
1121571056
Facility:
Name:
Sanatorio Británico-Clinical Oncology Department ( Site 0206)
Address:
City:
Rosario
Zip:
S2000CVB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5493416575134
Facility:
Name:
Sanatorio Parque ( Site 0205)
Address:
City:
Rosario
Zip:
S2000DSV
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5493416955611
Facility:
Name:
Hospital Aleman-Oncology ( Site 0202)
Address:
City:
Buenos Aires
Zip:
C1118AAT
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
541182770002306
Facility:
Name:
Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)
Address:
City:
Cordoba
Zip:
X5016KEH
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
543514862400
Facility:
Name:
Westmead Hospital-Department of Medical Oncology ( Site 0701)
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0298455200
Facility:
Name:
The Prince Charles Hospital ( Site 0700)
Address:
City:
Brisbane
Zip:
4032
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61736468111
Facility:
Name:
Fiona Stanley Hospital-Medical Oncology ( Site 0705)
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
08 61526530
Facility:
Name:
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4373276763220
Facility:
Name:
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)
Address:
City:
Wien
Zip:
1210
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+43 1 27700 72212
Facility:
Name:
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3281422111
Facility:
Name:
Liga Norte Riograndense Contra o Câncer ( Site 0301)
Address:
City:
Natal
Zip:
59062-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
558440095595
Facility:
Name:
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5551997292010
Facility:
Name:
Instituto de Oncologia Saint Gallen ( Site 0319)
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 0304)
Address:
City:
Barretos
Zip:
14784400
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+55 17 99662 8668
Facility:
Name:
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)
Address:
City:
São José do Rio Preto
Zip:
15090000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
551732015054
Facility:
Name:
St. Marys Hospital Center ( Site 0107)
Address:
City:
Montreal
Zip:
H3T 1M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
514-345-3511-3793
Facility:
Name:
FALP-UIDO ( Site 0401)
Address:
City:
Providencia
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)
Address:
City:
Santiago
Zip:
7500653
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56991612199
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0400)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56998744662
Facility:
Name:
ONCOCENTRO APYS-ACEREY ( Site 0410)
Address:
City:
Viña del Mar
Zip:
2520598
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56992369820
Facility:
Name:
Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613501085973
Facility:
Name:
Peking University People's Hospital. ( Site 1300)
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613651078631
Facility:
Name:
Fujian Cancer Hospital-oncology department ( Site 1314)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13805088816
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 132
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613802777270
Facility:
Name:
Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13902205332
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15972212919
Facility:
Name:
Hubei Cancer Hospital ( Site 1308)
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15871415599
Facility:
Name:
Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13973171096
Facility:
Name:
Nanjing First Hospital ( Site 1310)
Address:
City:
Nanjing
Zip:
210012
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13382080588
Facility:
Name:
The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618550399999
Facility:
Name:
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)
Address:
City:
Nanchang
Zip:
330209
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13870614026
Facility:
Name:
The First Hospital of Jilin University ( Site 1324)
Address:
City:
Changchun
Zip:
130031
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13596083366
Facility:
Name:
Sichuan Cancer hospital ( Site 1327)
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618908178797
Facility:
Name:
The Second People's Hospital of Neijiang ( Site 1322)
Address:
City:
Neijiang
Zip:
641199
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13698308655
Facility:
Name:
Yunnan Province Cancer Hospital ( Site 1315)
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13987123539
Facility:
Name:
Zhejiang Cancer Hospital ( Site 1309)
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613958108371
Facility:
Name:
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328)
Address:
City:
Hangzhou
Zip:
31009
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13867120566
Facility:
Name:
Taizhou Hospital of Zhejiang Province ( Site 1329)
Address:
City:
Linhai
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 136 0665 9889
Facility:
Name:
Ningbo No. 2 Hospital ( Site 1305)
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613957420885
Facility:
Name:
Clinique Teissier Groupe ( Site 1811)
Address:
City:
Valenciennes
Zip:
59304
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+33327142434
Facility:
Name:
HIA Sainte Anne ( Site 1800)
Address:
City:
Toulon
Zip:
83800 Cedex 9
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0033483162937
Facility:
Name:
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)
Address:
City:
Esslingen
Zip:
73730
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+49 71131032402
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:
4930130132629
Facility:
Name:
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006)
Address:
City:
Patras
Zip:
26504
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
306973801212
Facility:
Name:
251 Hellenic Air Force General Hospital ( Site 2003)
Address:
City:
Athens
Zip:
115 25
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+30 2107464642
Facility:
Name:
Athens Medical Center ( Site 2005)
Address:
City:
Athens
Zip:
151 25
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+30 6974992097
Facility:
Name:
Metaxa Cancer Hospital of Piraeus ( Site 2002)
Address:
City:
Piraeus
Zip:
185 37
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
306940583449
Facility:
Name:
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001)
Address:
City:
Heraklion
Zip:
715 00
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+30 2810392438
Facility:
Name:
University General Hospital of Larissa-Oncology Clinic ( Site 2004)
Address:
City:
Larissa
Zip:
411 10
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
302413502124
Facility:
Name:
Queen Mary Hospital ( Site 3400)
Address:
City:
Hksar
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+852 39103299
Facility:
Name:
Queen Elizabeth Hospital ( Site 3402)
Address:
City:
Yau Ma Tei
Zip:
999077
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
85235068888
Facility:
Name:
Rambam Health Care Campus-Oncology Division ( Site 2203)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97247776700
Facility:
Name:
Shaare Zedek Medical Center ( Site 2206)
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+972587040620
Facility:
Name:
Rabin Medical Center ( Site 2204)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+ 9729378101
Facility:
Name:
Sheba Medical Center ( Site 2200)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+972-54-9269938
Facility:
Name:
Chungbuk National University Hospital-Internal medicine ( Site 1000)
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82432696015
Facility:
Name:
National Cancer Center-Lung Cancer Center ( Site 1002)
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82319201694
Facility:
Name:
Seoul National University Bundang Hospital-Medical Oncology ( Site 1003)
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82317877071
Facility:
Name:
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001)
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-31-249-8455
Facility:
Name:
Keimyung University Dongsan Hospital CRC room 1 ( Site 1006)
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82532586671
Facility:
Name:
Asan Medical Center-Lung Cancer Center ( Site 1005)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230103215
Facility:
Name:
Samsung Medical Center-Division of Hematology/Oncology ( Site 1004)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-2-3410-3453
Facility:
Name:
Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458)
Address:
City:
Amersfoort
Zip:
3813TZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0031 338507843
Facility:
Name:
Sint Antonius Ziekenhuis, locatie Nieuwegein-Pulmonary disease ( Site 3455)
Address:
City:
Nieuwegein
Zip:
3435 CM
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
088 - 320 3000
Facility:
Name:
Akershus Universitetssykehus ( Site 2501)
Address:
City:
Lørenskog
Zip:
1478
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4767960000
Facility:
Name:
Drammen Sykehus, Vestre Viken HF ( Site 2502)
Address:
City:
Drammen
Zip:
3004
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4745226100
Facility:
Name:
Sykehuset Innlandet HF Gjøvik ( Site 2503)
Address:
City:
Gjøvik
Zip:
2819
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4791 50 62 00
Facility:
Name:
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604)
Address:
City:
Lima
Zip:
15036
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
956754968
Facility:
Name:
Oncosalud ( Site 0602)
Address:
City:
Lima
Zip:
15036
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5112016500x3009
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 2601)
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
661957237
Facility:
Name:
Bialostockie Centrum Onkologii ( Site 2604)
Address:
City:
Bialystok
Zip:
15-027
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48856784153
Facility:
Name:
Uniwersyteckie Centrum Kliniczne ( Site 2610)
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Spitalul Universitar de Urgență Elias ( Site 2804)
Address:
City:
București
Zip:
011461
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+40748052052
Facility:
Name:
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801)
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0040724543672
Facility:
Name:
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802)
Address:
City:
Florești
Zip:
407280
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40742206212
Facility:
Name:
SC ONCO CARD SRL ( Site 2808)
Address:
City:
Brasov
Zip:
500052
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
40734534257
Facility:
Name:
Hospital Insular de Gran Canaria-Oncology ( Site 2903)
Address:
City:
Las Palmas de Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34 928441738
Facility:
Name:
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902)
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34914521987
Facility:
Name:
Kantonsspital Graubünden-Medizin ( Site 3006)
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0041 81 256 66 46
Facility:
Name:
Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)
Address:
City:
Munsterlingen
Zip:
8596
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41812567572
Facility:
Name:
National Taiwan University Cancer Center (NTUCC) (Site #1105)
Address:
City:
Taipei City
Zip:
106
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Bin-Chi Liao
Phone:
88622312345671659
Facility:
Name:
Tri-Service General Hospital (Site # 1100)
Address:
City:
Taipei City
Zip:
114
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chen-Liang Tsai
Phone:
886287923311
Facility:
Name:
Taoyuan General Hospital (Site #1106)
Address:
City:
Taoyuan City
Zip:
33004
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu-Chi Chiu
Phone:
(886)905013013
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital (Site # 1103)
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jen-Yu Hung
Phone:
+888-7-3121101-5651
Facility:
Name:
Taichung Veterans General Hospital-Chest (Site #1101)
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tsung-Ying Yang
Phone:
8864235925253218
Facility:
Name:
National Cheng Kung University Hospital-Clinical Trial Center (site # 1102)
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Hui Lee
Phone:
886-912777918
Facility:
Name:
National Taiwan University Hospital-Oncology (Site # 1104)
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chih-Hsin Yang
Phone:
88622312345667511
Start date:
April 3, 2024
Completion date:
October 23, 2034
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
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/NCT06312137
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2870-019&&kw=2870-019
