Clinical trial NCT06312137: 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)
Official title: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Carcinoma
Lung cancer
Non-small cell lung cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi site study
Primary purpose: TREATMENT

Brief 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).


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 either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-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
* 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 history of allogeneic tissue/solid organ transplant
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy

Primary outcomes:
measure: Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to ~ 93 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~ 118 months
measure: Distant metastasis-free survival (DMFS) as assessed by investigator
timeFrame: Up to ~ 118 months
measure: Disease-Free Survival (DFS) as assessed by investigator
timeFrame: Up to ~ 118 months
measure: Lung Cancer Specific Survival (LCSS)
timeFrame: Up to ~ 118 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 118 months
measure: Number of Participants Who Discontinue Study Intervention Due to AEs
timeFrame: Up to ~ 118 months
measure: Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
timeFrame: Baseline and up to ~118 months
measure: Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
timeFrame: Baseline and up to ~118 months
measure: Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
timeFrame: Baseline and up to ~118 months
measure: Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
timeFrame: Baseline and up to ~118 months
measure: Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
timeFrame: Baseline and up to ~118 months
measure: Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
timeFrame: Baseline and up to ~118 months
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group-Research Department ( Site 0062)
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center ( Site 0070)
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute ( Site 0040)
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
state: California
city: San Francisco
country: United States
facility: San Francisco Oncology Associates ( Site 0066)
state: California
city: Stamford
country: United States
facility: Stamford Hospital ( Site 0083)
state: Connecticut
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 0038)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0018)
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine-Phase I ( Site 0056)
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital ( Site 0055)
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Cancer Center ( Site 0005)
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion ( Site 0063)
state: Georgia
city: Thomasville
country: United States
facility: Archbold Cancer Center ( Site 0071)
state: Georgia
city: Elmhurst
country: United States
facility: Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
state: Illinois
city: Naperville
country: United States
facility: Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
state: Illinois
city: Lafayette
country: United States
facility: Indiana University Health Arnett Cancer Center ( Site 0076)
state: Indiana
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
state: Kentucky
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Research - David C. Pratt Cancer Center ( Site 0006)
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
state: Nevada
city: Morristown
country: United States
facility: Atlantic Health Morristown Medical Center ( Site 0077)
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center ( Site 0054)
state: New York
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
state: North Dakota
city: Portland
country: United States
facility: Oregon Health and Science University ( Site 0052)
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0053)
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute- Research ( Site 0090)
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 0082)
state: Tennessee
city: Houston
country: United States
facility: Millennium Research & Clinical Development ( Site 0039)
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute ( Site 0042)
state: Utah
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
state: Buenos Aires
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0207)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio Británico-Clinical Oncology Department ( Site 0206)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0205)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0202)
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0701)
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital ( Site 0700)
state: Queensland
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital-Medical Oncology ( Site 0705)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)
state: Oberosterreich
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)
state: Tirol
city: Wien
country: Austria
facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)
city: Edegem
country: Belgium
facility: Antwerp University Hospital-Thoracic Oncology ( Site 1503)
state: Antwerpen
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)
state: Namur
city: Sint-Niklaas
country: Belgium
facility: VITAZ ( Site 1500)
state: Oost-Vlaanderen
city: Natal.
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer ( Site 0301)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição ( Site 0302)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 0319)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)
state: Sao Paulo
city: Greenfield Park
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)
state: Quebec
city: Montreal
country: Canada
facility: St. Marys Hospital Center ( Site 0107)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0104)
state: Quebec
city: Providencia
country: Chile
facility: FALP-UIDO ( Site 0401)
state: Region M. De Santiago
city: Santiago.
country: Chile
facility: Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0400)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0410)
state: Valparaiso
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302)
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital. ( Site 1300)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital-oncology department ( Site 1314)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 1320)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-henan cancer hospital ( Site 1316)
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery ( Site 1306)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 1308)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1312)
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital ( Site 1310)
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)
state: Jiangsu
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 1324)
state: Jilin
city: Xian
country: China
facility: The Second Affiliated Hospital of Air Force Medical University ( Site 1332)
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 1321)
state: Shandong
city: Shangai
country: China
facility: Zhongshan Hospital Fudan University ( Site 1325)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 1304)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 1327)
state: Sichuan
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang ( Site 1322)
state: Sichuan
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 1315)
state: Yunnan
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of-Thoracic Cardiovascular Surgery Ward ( Site 1303)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 1309)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328)
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 1329)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No. 2 Hospital ( Site 1305)
state: Zhejiang
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1600)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1601)
state: Ostrava Mesto
city: Brest
country: France
facility: CHRU de Brest ( Site 1804)
state: Finistere
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)
state: Haute-Garonne
city: Rouen
country: France
facility: CHU Charles Nicolle ( Site 1803)
state: Haute-Normandie
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)
state: Haute-Vienne
city: Paris
country: France
facility: Groupe hospitalier Paris saint Joseph. ( Site 1807)
state: Ile-de-France
city: Valenciennes
country: France
facility: Clinique Teissier Groupe ( Site 1811)
state: Nord
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)
state: Puy-de-Dome
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)
state: Rhone
city: Toulon
country: France
facility: HIA Sainte Anne ( Site 1800)
state: Var
city: Paris
country: France
facility: Hôpital Tenon ( Site 1802)
city: Esslingen
country: Germany
facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)
state: Baden-Wurttemberg
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz ( Site 1911)
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)
state: Sachsen-Anhalt
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)
state: Thuringen
city: Berlin
country: Germany
facility: Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006)
state: Achaia
city: Athens
country: Greece
facility: 251 Hellenic Air Force General Hospital ( Site 2003)
state: Attiki
city: Athens
country: Greece
facility: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2000)
state: Attiki
city: Athens
country: Greece
facility: Athens Medical Center ( Site 2005)
state: Attiki
city: Piraeus
country: Greece
facility: Metaxa Cancer Hospital of Piraeus ( Site 2002)
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001)
state: Irakleio
city: Larissa
country: Greece
facility: University General Hospital of Larissa-Oncology Clinic ( Site 2004)
state: Thessalia
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center ( Site 2007)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 3400)
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre ( Site 3403)
city: Yau Ma Tei
country: Hong Kong
facility: Queen Elizabeth Hospital ( Site 3402)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 2203)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 2206)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 2204)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 2200)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)
state: Emilia-Romagna
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2301)
state: Lombardia
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 2309)
state: Roma
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 2307)
state: Toscana
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni-ONCOLOGY ( Site 2310)
city: Genova
country: Italy
facility: Ospedale San Martino ( Site 2313)
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 2311)
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 2312)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 2303)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 2306)
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 1216)
state: Ehime
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan ( Site 1217)
state: Fukuoka
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 1213)
state: Hyogo
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 1207)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 1206)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 1211)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 1212)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 1201)
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital ( Site 1204)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 1203)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 1218)
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 1200)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 1215)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 1208)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1214)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1210)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 1205)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital-Internal medicine ( Site 1000)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Lung Cancer Center ( Site 1002)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Medical Oncology ( Site 1003)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital CRC room 1 ( Site 1006)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Lung Cancer Center ( Site 1005)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1004)
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0506)
state: Jalisco
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0509)
state: Oaxaca
city: Chihuahua
country: Mexico
facility: Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0504)
city: Chihuahua
country: Mexico
facility: Mediadvance Clinical ( Site 0502)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0507)
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 3453)
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle-Poli Longziekten ( Site 3454)
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458)
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum ( Site 3452)
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Sint Antonius Ziekenhuis ( Site 3455)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0800)
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus ( Site 2501)
state: Akershus
city: Drammen
country: Norway
facility: Drammen Sykehus, Vestre Viken HF ( Site 2502)
state: Buskerud
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet HF Gjøvik ( Site 2503)
state: Oppland
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604)
city: Lima
country: Peru
facility: Oncosalud ( Site 0602)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0600)
city: Lima
country: Peru
facility: Instituto Neuro Cardiovascular de las Americas ( Site 0607)
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins-medical oncology ( Site 0603)
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2600)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2601)
state: Podkarpackie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 2604)
state: Podlaskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 2610)
state: Pomorskie
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 2613)
state: Pomorskie
city: Olsztyn
country: Poland
facility: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2606)
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2602)
state: Wielkopolskie
city: Matosinhos
country: Portugal
facility: UNIDADE LOCAL DE SAUDE DE MATOSINHOS-Serviço de Oncologia ( Site 2705)
state: Porto
city: Coimbra
country: Portugal
facility: Instituto Portugês de Oncologia de Coimbra Francisco Gentil-Oncologia Médica ( Site 2704)
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
city: Bucharest
country: Romania
facility: MEMORIAL HEALTHCARE INTERNATIONAL S.R.L.. ( Site 2803)
state: Bucuresti
city: București
country: Romania
facility: Spitalul Universitar de Urgență Elias ( Site 2804)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801)
state: Cluj
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802)
state: Cluj
city: Brasov
country: Romania
facility: SC ONCO CARD SRL ( Site 2808)
city: L Hospitalet
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2901)
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2905)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 2903)
state: Las Palmas
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2900)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos-Oncology Department ( Site 2904)
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden-Medizin ( Site 3006)
state: Grisons
city: Munsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)
state: Thurgau
city: Lausanne
country: Switzerland
facility: CHUV (centre hospitalier universitaire vaudois) ( Site 3003)
state: Vaud
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital Cantonal ( Site 3004)
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 1105)
state: Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital ( Site 1100)
state: Taipei
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital ( Site 1106)
state: Taoyuan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital-Chest ( Site 1101)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 1104)
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3106)
city: Ankara
country: Turkey
facility: Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 3104)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 3101)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 3110)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3103)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3107)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: