Clinical trial NCT06422143: Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Official title: Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
NSCLC
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are allocated to a single induction arm, then assigned randomly to one of 2 maintenance arms.
Primary purpose: TREATMENT

Brief summary: This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Detailed description: All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]
* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
* Has life expectancy ≥3 months
* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* 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 before allocation
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Participants who have adverse events (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)
* Has adequate organ function
* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12
* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* 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 QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
* Received prior therapy with an anti-programmed cell death-1 (PD-1), anti-PD-Ligand 1 (PD-L1), or anti-PD-Lignad 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic Tlymphocyte-associated protein 4, OX-40, CD137) \[Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\]
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
* Received radiation therapy to the lung that is \>30 Gray 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
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Received prior treatment with a topoisomerase I inhibitor-containing ADC
* Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known central nervous system (CNS) metastases/carcinomatous meningitis
* Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed)
* History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Active infection requiring systemic therapy
* History of allogeneic tissue/solid organ transplant

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to ~50 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to ~79 months
measure: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to ~79 months
measure: Number of Participants Discontinuing from Study Therapy Due to AE(s)
timeFrame: Up to ~79 months
measure: Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)
timeFrame: Baseline and up to ~79 months
measure: Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)
timeFrame: Baseline and up to ~79 months
measure: Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)
timeFrame: Baseline and up to ~79 months
measure: Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)
timeFrame: Baseline and up to ~79 months
measure: Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)
timeFrame: Up to ~79 months
measure: TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)
timeFrame: Up to ~79 months
measure: TTD in Cough Score (EORTC QLQ-LC13 Item 31)
timeFrame: Up to ~79 months
measure: TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)
timeFrame: Up to ~79 months
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
state: California
city: Golden
country: United States
facility: Exempla Lutheran Medical Center ( Site 0119)
state: Colorado
city: Grand Junction
country: United States
facility: Intermountain Health St. Mary's Regional Hospital ( Site 0116)
state: Colorado
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0109)
state: Florida
city: Columbus
country: United States
facility: Centricity Research Columbus Cancer Center ( Site 0111)
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0145)
state: Illinois
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
state: Minnesota
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)
state: New Mexico
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute ( Site 0147)
state: Pennsylvania
city: Houston
country: United States
facility: Oncology Consultants P.A. ( Site 0124)
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center ( Site 0132)
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming ( Site 0203)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)
state: Buenos Aires
city: Rio Cuarto.
country: Argentina
facility: Instituto Médico Río Cuarto ( Site 0204)
state: Cordoba
city: San Carlos de Bariloche
country: Argentina
facility: Fundacion Intecnus ( Site 0205)
state: Rio Negro
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0201)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0202)
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)
state: Oberosterreich
city: Wien
country: Austria
facility: Klinik Hietzing ( Site 0740)
city: Wien
country: Austria
facility: Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)
city: Wien
country: Austria
facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)
city: Recife
country: Brazil
facility: Hospital de Câncer de Recife ( Site 0312)
state: Pernambuco
city: Terezina
country: Brazil
facility: Oncoclínica Oncologistas Associados ( Site 0309)
state: Piaui
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição ( Site 0300)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 0304)
state: Rio Grande Do Sul
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto ( Site 0310)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano ( Site 0307)
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital ( Site 0153)
state: Ontario
city: Montreal
country: Canada
facility: St. Marys Hospital Center ( Site 0105)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0103)
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)
state: Quebec
city: Talca
country: Chile
facility: Centro de Investigación del Maule ( Site 0419)
state: Maule
city: Santiago
country: Chile
facility: FALP ( Site 0409)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0407)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0400)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0420)
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 2411)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 2412)
state: Beijing
city: Chongqing
country: China
facility: Army Medical Center of People's Liberation Army-respiratory ( Site 2426)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 2419)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-oncology ( Site 2420)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-Pneumology department ( Site 2423)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)
state: Hunan
city: Huai'an
country: China
facility: First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)
state: Jiangxi
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital-GCP office ( Site 2413)
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University-Oncology ( Site 2414)
state: Jilin
city: Shanghai
country: China
facility: Shanghai East Hospital ( Site 2428)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital ( Site 2427)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University ( Site 2422)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 2421)
state: Sichuan
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)
state: Xinjiang
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 2430)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Centro Cancerológico del Caribe (CECAC) ( Site 0509)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
state: Cesar
city: Bogota
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)
state: Distrito Capital De Bogota
city: Pereira.
country: Colombia
facility: Oncologos del Occidente ( Site 0504)
state: Risaralda
city: Cali
country: Colombia
facility: Fundación Valle del Lili-Oncology CIC ( Site 0505)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800)
state: Brno-mesto
city: Ostrava-Vitkovice
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803)
state: Ostrava Mesto
city: Marseille
country: France
facility: Clinique Clairval ( Site 0904)
state: Bouches-du-Rhone
city: Vantoux
country: France
facility: Hôpital Robert Schuman ( Site 0907)
state: Lorraine
city: ANGERS cedex 02
country: France
facility: Institut de Cancérologie de l'Ouest ( Site 0908)
state: Maine-et-Loire
city: Avignon
country: France
facility: Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)
state: Vaucluse
city: La Roche-sur-Yon
country: France
facility: CHD Vendee ( Site 0901)
state: Vendee
city: Paris
country: France
facility: Hôpital Saint-Louis ( Site 0906)
city: Dortmund
country: Germany
facility: GEFOS Gesellschaft f. onkologische Studien ( Site 1005)
state: Nordrhein-Westfalen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)
state: Bacs-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)
state: Gyor-Moson-Sopron
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)
state: Jasz-Nagykun-Szolnok
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum ( Site 1102)
state: Pest
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház ( Site 1110)
state: Zala
city: Budapest
country: Hungary
facility: Országos Korányi Pulmonológiai Intézet ( Site 1104)
city: Dublin
country: Ireland
facility: St. James's Hospital ( Site 1200)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1302)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1300)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1303)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1301)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)
state: Campania
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)
state: Milano
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)
state: Roma
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)
city: Genova
country: Italy
facility: Ospedale San Martino ( Site 1407)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 2502)
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 2519)
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 2515)
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital ( Site 2514)
state: Aomori
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 2511)
state: Ehime
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 2510)
state: Gunma
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 2508)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 2513)
state: Ishikawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 2521)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 2518)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 2504)
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital ( Site 2522)
state: Mie
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 2507)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2503)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 2512)
state: Saitama
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 2500)
state: Tokyo
city: Ota
country: Japan
facility: Toho University Omori Medical Center ( Site 2520)
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine ( Site 2516)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 2517)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 2509)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2505)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2506)
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)
state: Incheon
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital ( Site 2104)
state: Kyongsangnam-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 2100)
state: Pusan-Kwangyokshi
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)
state: Taegu-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2107)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital ( Site 2101)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2105)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital-Internal Medicine ( Site 2103)
city: Chiclayo
country: Peru
facility: Clínicas AUNA Sede Chiclayo ( Site 0604)
state: Lambayeque
city: Lima
country: Peru
facility: Oncosalud-Clinical Research ( Site 0600)
city: Lima
country: Peru
facility: Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1503)
state: Kujawsko-pomorskie
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)
state: Kujawsko-pomorskie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)
state: Podkarpackie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1517)
state: Zachodniopomorskie
city: Bucharest
country: Romania
facility: Centrul Medical Medicover Victoria ( Site 2000)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 2002)
state: Cluj
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)
state: Dolj
city: Timisoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 2005)
state: Timis
city: Brasov
country: Romania
facility: SC ONCO CARD SRL ( Site 2007)
city: Sibiu
country: Romania
facility: Clinica Polisano ( Site 2008)
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 1701)
state: Las Palmas
city: Málaga
country: Spain
facility: Hospital Quirón Málaga ( Site 1704)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 2209)
state: Taipei
city: Taoyuan City
country: Taiwan
facility: Taoyuan General Hospital ( Site 2203)
state: Taoyuan
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2204)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2205)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 2208)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital-Chest Medicine ( Site 2201)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)
city: Mueang
country: Thailand
facility: Prapokklao Hospital ( Site 2306)
state: Chanthaburi
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University ( Site 2305)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 2301)
state: Krung Thep Maha Nakhon
city: Dusit
country: Thailand
facility: Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)
state: Krung Thep Maha Nakhon
city: Mueang Lampang
country: Thailand
facility: Lampang Cancer Hospital ( Site 2304)
state: Lampang
city: HatYai
country: Thailand
facility: Songklanagarind hospital ( Site 2303)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 2302)
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 1811)
state: Istanbul
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 1804)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)
city: Kayseri
country: Turkey
facility: Memorial Kayseri Hastanesi ( Site 1805)
city: Mersin
country: Turkey
facility: Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 1806)
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Medical City ( Site 2600)
state: Abu Zaby
city: London
country: United Kingdom
facility: St Bartholomew's Hospital ( Site 1901)
state: London, City Of
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
state: Nottinghamshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: