Clinical trial NCT03924869: Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
Official title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 448
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 purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).

Detailed description: As of protocol amendment 8, the study was stopped due to an interim analysis that did not support the study primary and key secondary endpoints. All study participants stopped ongoing treatment with pembrolizumab/placebo, and must complete end of trial and safety follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, \>2 nodules or 2 nodules that cannot be treated in one field (\>2 cm apart and/or total planned target volume \[PTV\] \>163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
* Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
* Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Is able to receive SBRT and does not have an ultra-centrally located tumor
* Has adequate organ function within 7 days prior to the start of study treatment
* A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
* Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor

Exclusion Criteria:

* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], tumor necrosis factor receptor superfamily member 4 \[OX-40\], tumor necrosis factor receptor superfamily member 9 \[CD137\])
* Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
* Has received a live vaccine within 30 days prior to the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of 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 treatment
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
* Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
* Have not adequately recovered from major surgery or have ongoing surgical complications
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Event-free Survival (EFS)
timeFrame: Up to approximately 56.8 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 56.8 months
measure: Time to Death or Distant Metastases (TDDM)
timeFrame: Up to approximately 56.8 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 63 months
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score
timeFrame: Baseline and up to 24 weeks
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score
timeFrame: Baseline and up to 24 weeks
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score
timeFrame: Baseline and up to 24 weeks
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
timeFrame: Baseline and up to 24 weeks
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
timeFrame: Baseline and up to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama ( Site 0099)
state: Alabama
city: Mobile
country: United States
facility: Infirmary Cancer Care ( Site 3044)
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology ( Site 3063)
state: Alaska
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center ( Site 3029)
state: Arizona
city: Little Rock
country: United States
facility: CARTI Cancer Center ( Site 3045)
state: Arkansas
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center ( Site 0007)
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System ( Site 3039)
state: California
city: Denver
country: United States
facility: National Jewish Health ( Site 0010)
state: Colorado
city: New Haven
country: United States
facility: Yale University ( Site 0011)
state: Connecticut
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0067)
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
state: Florida
city: Goshen
country: United States
facility: Goshen Center for Cancer Care ( Site 0022)
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis ( Site 0024)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky School of Medicine & Hospitals ( Site 0026)
state: Kentucky
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore ( Site 3011)
state: Maryland
city: Westminster
country: United States
facility: William E. Kahlert Regional Cancer Center ( Site 3031)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)
state: Massachusetts
city: Danvers
country: United States
facility: Mass General / North Shore Center for Outpatient Care ( Site 3040)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts ( Site 0029)
state: Massachusetts
city: Bemidji
country: United States
facility: Sanford Bemidji ( Site 0080)
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota ( Site 0069)
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital ( Site 3058)
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 3012)
state: Montana
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0043)
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY ( Site 3055)
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital ( Site 0046)
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center ( Site 3057)
state: New York
city: White Plains
country: United States
facility: White Plains Hospital ( Site 3014)
state: New York
city: Fargo
country: United States
facility: Sanford Health Roger Maris Cancer Center ( Site 0079)
state: North Dakota
city: Allentown
country: United States
facility: Lehigh Valley Hospital- Cedar Crest ( Site 3005)
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's University Health Network ( Site 3006)
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University Milton S. Hershey Medical Center ( Site 0064)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0051)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 3028)
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center ( Site 3041)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic ( Site 0053)
state: South Dakota
city: Johnson City
country: United States
facility: Mountain States Health Alliance ( Site 3054)
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 3010)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center ( Site 0075)
state: Tennessee
city: Spokane Valley
country: United States
facility: Cancer Care Northwest ( Site 0063)
state: Washington
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 0204)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0207)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0205)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 0200)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming ( Site 0203)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0201)
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital ( Site 2500)
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore ( Site 2508)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 2502)
state: Queensland
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart ( Site 2507)
state: Tasmania
city: Melbourne
country: Australia
facility: Austin Health ( Site 2501)
state: Victoria
city: Linz
country: Austria
facility: Keppler Universitatsklinikum ( Site 0806)
state: Oberosterreich
city: Graz
country: Austria
facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitatsklinik LKH Innsbruck ( Site 0802)
state: Tirol
city: Vienna
country: Austria
facility: Social Medical Center - Otto Wagner Hospital ( Site 0801)
state: Wien
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clínica de Oncologia Reichow ( Site 0319)
state: Santa Catarina
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro ( Site 0313)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0316)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0312)
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0105)
state: New Brunswick
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0100)
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Hospital ( Site 0102)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital ( Site 0104)
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Sault Area Hospital ( Site 0101)
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute ( Site 0107)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0113)
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont ( Site 0111)
state: Quebec
city: Poitiers
country: France
facility: CHU Poitiers ( Site 1109)
state: Ain
city: Brest
country: France
facility: CHU de Brest -Site Hopital Morvan ( Site 1100)
state: Finistere
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 1102)
state: Gironde
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1108)
state: Herault
city: Rouen
country: France
facility: CHU de Rouen ( Site 1113)
state: Seine-Maritime
city: Amiens
country: France
facility: Hopital Sud du Amiens ( Site 1115)
state: Somme
city: Paris
country: France
facility: Institut Curie ( Site 1112)
city: Paris
country: France
facility: Hopital Cochin ( Site 1107)
city: Paris
country: France
facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)
city: Esslingen
country: Germany
facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)
state: Baden-Wurttemberg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg. ( Site 1204)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 1209)
state: Bayern
city: Gießen
country: Germany
facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)
state: Hessen
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg ( Site 1202)
state: Niedersachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 1201)
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 1207)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)
state: Bacs-Kiskun
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)
state: Baranya
city: Miskolc
country: Hungary
facility: CRU Hungary KFT ( Site 2309)
state: Borsod-Abauj-Zemplen
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)
state: Fejer
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 2305)
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)
state: Jasz-Nagykun-Szolnok
city: Torokbalint
country: Hungary
facility: Törökbálinti Tüdőgyógyintézet ( Site 2302)
state: Pest
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)
state: Somogy
city: Farkasgyepu
country: Hungary
facility: Farkasgyepui Tudogyogyintezet ( Site 2313)
state: Veszprem
city: Budapest
country: Hungary
facility: Semmelweis University ( Site 2303)
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 2308)
city: Chieti
country: Italy
facility: Ospedale Santissima Annunziata ( Site 1303)
city: Firenze
country: Italy
facility: A.O. Universitaria Careggi ( Site 1301)
city: Modena
country: Italy
facility: Policlinico di Modena ( Site 1306)
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli ( Site 1302)
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2804)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2800)
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 2815)
state: Fukuoka
city: Kobe
country: Japan
facility: Kobe Minimally Invasive Cancer Center ( Site 2811)
state: Hyogo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 2809)
state: Ibaraki
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 2814)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2808)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 2813)
state: Osaka
city: Chuo
country: Japan
facility: University of Yamanashi Hospital ( Site 2807)
state: Yamanashi
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 2806)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2816)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 2810)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2801)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2812)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 2802)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2803)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 2805)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 2605)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 2604)
state: Kyonggi-do
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2606)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2600)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2603)
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate ( Site 1405)
state: Gelderland
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)
state: Utrecht
city: Grafton
country: New Zealand
facility: Auckland City Hospital ( Site 2900)
state: Auckland
city: Trondheim
country: Norway
facility: St Olavs Hospital ( Site 1504)
state: Sor-Trondelag
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)
state: Vestfold
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)
state: Lodzkie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)
state: Slaskie
city: Olsztyn
country: Poland
facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)
state: Warminsko-mazurskie
city: Florești
country: Romania
facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)
state: Cluj
city: Cluj
country: Romania
facility: Institutul Oncologic-Oncologie Medicala ( Site 3202)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)
state: Chelyabinskaya Oblast
city: Lipetsk
country: Russian Federation
facility: GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)
state: Lipetskaya Oblast
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research center ( Site 2013)
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology ( Site 2011)
state: Moskva
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Medical institute named after Berezin Sergey ( Site 2009)
state: Sankt-Peterburg
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 2012)
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)
state: Tatarstan, Respublika
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1601)
state: Madrid
city: Valencia
country: Spain
facility: Hospital Universitario La Fe ( Site 1603)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1602)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1604)
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 1706)
state: Geneve
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 1700)
state: Zurich
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital ( Site 3300)
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 3303)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 3301)
city: Adana
country: Turkey
facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty ( Site 2100)
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)
city: Istanbul
country: Turkey
facility: Kartal Training and Research Hospital ( Site 2102)
city: Izmir
country: Turkey
facility: I.E.U. Medical Point Hastanesi ( Site 2115)
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty ( Site 2109)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)
city: Dnipro
country: Ukraine
facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Centre of Oncology-Thoracic organs ( Site 2202)
state: Kharkivska Oblast
city: Kropyvnitskiy
country: Ukraine
facility: Ukrainian Center of Tomotherapy ( Site 2206)
state: Kirovohradska Oblast
city: Kapitanivka Village
country: Ukraine
facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)
state: Kyivska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 2208)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 2200)
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 1802)
state: Bristol, City Of
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 1813)
state: Camden
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital ( Site 1801)
state: Derbyshire
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Center NHS FT ( Site 1800)
state: England
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)
state: Lancashire
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary ( Site 1811)
state: Leicestershire
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust ( Site 1806)
state: London, City Of
city: London
country: United Kingdom
facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)
state: London, City Of
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Foundation NHS Trust ( Site 1805)
state: Norfolk
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust ( Site 1812)
state: Oxfordshire
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital NHS Trust ( Site 1810)
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital ( Site 1803)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: