Clinical trial NCT06170788: Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Official title: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.

All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

  * Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
  * Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
  * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
  * A life expectancy of at least 3 months.
  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Has Grade ≥2 peripheral neuropathy.
* 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 clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received radiation therapy to the lung that is \>30 Gy within 6 months of start of study intervention.
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
* Active infection requiring systemic therapy
* Concurrent active Hepatitis B and Hepatitis C virus infection.
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* History of allogeneic tissue/solid organ transplant.
* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 48 months
measure: Objective Response (OR)
timeFrame: Up to approximately 48 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 48 months
measure: Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score
timeFrame: Baseline and up to approximately 24 months
measure: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
timeFrame: Baseline and up to approximately 24 months
measure: Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score
timeFrame: Baseline and up to approximately 24 months
measure: Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score
timeFrame: Baseline and up to approximately 24 months
measure: Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)
timeFrame: Up to approximately 24 months
measure: Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
timeFrame: Up to approximately 24 months
measure: Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).
timeFrame: Up to approximately 24 months
measure: Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
timeFrame: Up to approximately 24 months
measure: Percentage of Participants That Experience at Least 1 Adverse Event
timeFrame: Up to approximately 27 months
measure: Percentage of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
state: California
city: Grand Junction
country: United States
facility: Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
state: Colorado
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
state: Georgia
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0143)
state: Maine
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
state: Massachusetts
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 0104)
state: Mississippi
city: Reno
country: United States
facility: Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
state: Nevada
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0119)
state: Ohio
city: Corvallis
country: United States
facility: Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
state: Oregon
city: Houston
country: United States
facility: Oncology Consultants P.A. ( Site 0129)
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming ( Site 0306)
state: Buenos Aires
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0304)
state: Caba
city: Río Cuarto
country: Argentina
facility: Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
state: Cordoba
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario ( Site 0301)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0300)
city: Port Macquarie
country: Australia
facility: Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 3000)
state: New South Wales
city: Ballarat Central
country: Australia
facility: Grampians Health-Medical Oncology ( Site 3001)
state: Victoria
city: Epping
country: Australia
facility: Northern Hospital ( Site 3003)
state: Victoria
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Clinica Viver ( Site 0400)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA ( Site 0405)
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0203)
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Hospital ( Site 0202)
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0200)
state: Quebec
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
state: Maule
city: Santiago.
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0507)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Orlandi Oncologia-Oncology ( Site 0504)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0509)
state: Region M. De Santiago
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0516)
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University ( Site 3133)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 3131)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University ( Site 3123)
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University ( Site 3135)
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 3116)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 3130)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3106)
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital-oncology department ( Site 3136)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 3138)
state: Hunan
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital ( Site 3143)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital-oncology department ( Site 3126)
state: Jilin
city: Jinan
country: China
facility: Jinan Central Hospital-oncology department ( Site 3122)
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 3119)
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changhai Hospital ( Site 3125)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University ( Site 3124)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 3105)
state: Sichuan
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang ( Site 3140)
state: Sichuan
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 3139)
state: Yunnan
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)
state: Zhejiang
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 0602)
state: Cordoba
city: Bogota
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
state: Distrito Capital De Bogota
city: Pereira.
country: Colombia
facility: Oncologos del Occidente ( Site 0603)
state: Risaralda
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103)
state: Ostrava Mesto
city: Pardubice
country: Czechia
facility: Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 1105)
state: Pardubicky Kraj
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106)
state: Praha 2
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)
state: Nordjylland
city: Odense C
country: Denmark
facility: Odense Universitetshospital ( Site 1200)
state: Syddanmark
city: Marseille
country: France
facility: Hôpital Saint Joseph-ONCOLOGY ( Site 1308)
state: Bouches-du-Rhone
city: Montpellier
country: France
facility: Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)
state: Herault
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)
state: Limousin
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly ( Site 1301)
state: Meurthe-et-Moselle
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque ( Site 1300)
state: Pyrenees-Atlantiques
city: Gleize
country: France
facility: L HOPITAL NORD OUEST ( Site 1310)
state: Rhone
city: Amiens
country: France
facility: Clinique de l'Europe-Service de pneumologie ( Site 1304)
state: Somme
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)
state: Vienne
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)
state: Bayern
city: München
country: Germany
facility: Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)
state: Bayern
city: Nuremberg
country: Germany
facility: Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)
state: Bayern
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)
state: Niedersachsen
city: Moers
country: Germany
facility: Bethanien Krankenhaus Moers ( Site 1400)
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 1404)
state: Rheinland-Pfalz
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf-Onkologie ( Site 1401)
state: Schleswig-Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1807)
state: Emilia-Romagna
city: Udine
country: Italy
facility: P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1803)
state: Friuli-Venezia Giulia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
state: Lombardia
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804)
state: Puglia
city: Catanzaro
country: Italy
facility: AOU Renato Dulbecco ( Site 1801)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806)
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 3411)
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 3415)
state: Ehime
city: Fukuoka,
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 3417)
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 3418)
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 3402)
state: Gunma
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center ( Site 3426)
state: Hyogo
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 3428)
state: Iwate
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 3421)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital ( Site 3425)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 3408)
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital ( Site 3422)
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 3424)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 3400)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3412)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3413)
state: Osaka
city: Ureshino
country: Japan
facility: National Hospital Organization Ureshino Medical Center ( Site 3427)
state: Saga
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 3409)
state: Saitama
city: Suntogun
country: Japan
facility: Shizuoka Cancer Center ( Site 3410)
state: Shizuoka
city: Shimotsugagun
country: Japan
facility: Dokkyo Medical University Hospital ( Site 3401)
state: Tochigi
city: Bunkyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 3405)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 3404)
state: Tokyo
city: Ota
country: Japan
facility: Toho University Omori Medical Center ( Site 3420)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 3407)
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine ( Site 3406)
state: Tokyo
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 3423)
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 3416)
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital ( Site 3419)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3414)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital-Internal medicine ( Site 3804)
state: Chungbuk
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 3808)
state: Kang-won-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 3801)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital-Hematology-Oncology ( Site 3806)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital CRC room 1 ( Site 3807)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Lung Cancer Center ( Site 3805)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
city: Mexico City
country: Mexico
facility: Higiea Oncologia ( Site 0721)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715)
state: Jalisco
city: Monterrey
country: Mexico
facility: Axis Heilsa S. de R.L. de C.V. ( Site 0719)
state: Nuevo Leon
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713)
state: San Luis Potosi
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0718)
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncología ( Site 0714)
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901)
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902)
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle-Poli Longziekten ( Site 1903)
state: Overijssel
city: Arequipa
country: Peru
facility: Clinica Vallesur - AUNA ( Site 0854)
state: Ariqipa
city: Surquillo
country: Peru
facility: Detecta Clínica ( Site 0853)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850)
city: Lima
country: Peru
facility: Hospital Cayetano Heredia-Oncology ( Site 0855)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
state: Kujawsko-pomorskie
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 2013)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016)
state: Kujawsko-pomorskie
city: Łódź
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital ( Site 2012)
state: Lodzkie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015)
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Gruźlicy i Chorób Płuc w Warszawie-3rd Dep of Lung Diseases and Oncology ( Site 2011)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
state: Podkarpackie
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 2104)
state: Lisboa
city: Lisbon
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101)
state: Lisboa
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103)
state: Porto
city: Funchal
country: Portugal
facility: Hospital Dr. Nélio Mendonça ( Site 2105)
state: Regiao Autonoma Da Madeira
city: Lisboa
country: Portugal
facility: Hospital CUF - Tejo ( Site 2100)
city: Jerez de la Frontera
country: Spain
facility: Hospital Jerez de la Frontera-UGC Oncología ( Site 2333)
state: Cadiz
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335)
state: La Coruna
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331)
state: Madrid
city: Málaga
country: Spain
facility: H.R.U Malaga - Hospital General ( Site 2332)
state: Malaga
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 2330)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 3902)
state: Kaohsiung
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch ( Site 3908)
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 3907)
state: Taipei
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch ( Site 3901)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital-Chest ( Site 3905)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 3906)
city: Bangkok
country: Thailand
facility: Chulalongkorn University-Medicine ( Site 4003)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 4000)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001)
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 2508)
state: Istanbul
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503)
state: Izmir
city: Talas
country: Turkey
facility: Erciyes University ( Site 2511)
state: Kayseri
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507)
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi ( Site 2500)
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Universitesi ( Site 2509)
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 2601)
state: England
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital-Oncology Department ( Site 2603)
state: Hampshire
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital-Oncology Research ( Site 2606)
state: Kent
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)
state: London, City Of
city: Central Middlesbrough
country: United Kingdom
facility: James Cook University Hospital ( Site 2604)
state: Middlesbrough
city: Hanoi
country: Vietnam
facility: K Hospital - National Cancer Hospital ( Site 4174)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: National Lung Hospital-Oncology Department ( Site 4175)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: Tam Anh General Hospital ( Site 4179)
state: Ha Noi
city: HCM
country: Vietnam
facility: Thong Nhat Hospital ( Site 4170)
state: Ho Chi Minh
city: Ho Chi Minh
country: Vietnam
facility: Cho Ray Hospital ( Site 4171)
city: Ho Chi Minh
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: