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NCT03976323CompletedPhase 3

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1003 (actual)
First submitted
3 Jun 2019
Start date
28 Jun 2019
Primary completion date
7 Feb 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT03976323
EU CT number
2023-509774-40-00
EudraCT number
2018-004720-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1003
  • From 28 Jun 2019 to the primary completion date, 7 Feb 2024
  • 167 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  • Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
  • Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Other illness

  • Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
  • Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
  • Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
  • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Lab values

  • Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).

Other

  • Has predominantly squamous cell histology NSCLC.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Who the study is looking for

  • Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
  • Have stage IV nonsquamous NSCLC.
  • Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
  • Have measurable disease based on RECIST 1.1.
  • Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
    • Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
  • Have a life expectancy of at least 3 months.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
  • Have not received prior systemic treatment for their advanced/metastatic NSCLC.
  • Have adequate organ function.
  • Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
  • Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (167)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano Regional del Sur ( Site 0509)
Coordinator of this site? Confirm its status
Bahía BlancaArgentinaUnknown status
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511)
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Hospital Britanico de Buenos Aires ( Site 0500)
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Clínica Universitaria Reina Fabiola ( Site 0505)
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Instituto Medico Rio Cuarto ( Site 0501)
Coordinator of this site? Confirm its status
Río CuartoArgentinaUnknown status
Centro Oncológico de Rosario ( Site 0507)
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Centro Medico San Roque ( Site 0506)
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
Coordinator of this site? Confirm its status
Santa FeArgentinaUnknown status
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaCompleted
Klinikum Wels-Grieskirchen GmbH
Coordinator of this site? Confirm its status
WelsAustriaCompleted
Monash Cancer Centre ( Site 1205)
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Liverpool Hospital ( Site 1201)
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
Townsville General Hospital ( Site 1202)
Coordinator of this site? Confirm its status
TownsvilleAustraliaUnknown status
Southern Medical Day Care Centre ( Site 1200)
Coordinator of this site? Confirm its status
WollongongAustraliaUnknown status
Oncologica do Brasil ( Site 0210)
Coordinator of this site? Confirm its status
BelémBrazilUnknown status
Hospital Tacchini ( Site 0208)
Coordinator of this site? Confirm its status
Bento GonçalvesBrazilUnknown status
YNOVA Pesquisa Clinica ( Site 0215)
Coordinator of this site? Confirm its status
FlorianópolisBrazilUnknown status
Instituto do Cancer do Ceara ( Site 0201)
Coordinator of this site? Confirm its status
FortalezaBrazilUnknown status
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
Coordinator of this site? Confirm its status
ItajaíBrazilUnknown status
Centro de Hematologia e Oncologia ( Site 0205)
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JoinvilleBrazilUnknown status
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Hospital Sao Rafael ( Site 0212)
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
Saint Gallen Instituto de Oncologia ( Site 0206)
Coordinator of this site? Confirm its status
Santa Cruz do SulBrazilUnknown status
Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
Coordinator of this site? Confirm its status
Sao Jose Rio PretoBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0214)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Hospital Paulistano - Amil Clinical Research ( Site 0207)
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São PauloBrazilUnknown status
Health Sciences North Research Institute ( Site 0115)
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Greater SudburyCanadaUnknown status
CISSS de la Monteregie-Centre ( Site 0114)
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Greenfield ParkCanadaUnknown status
Queen Elizabeth II Health Sciences Centre ( Site 0107)
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HalifaxCanadaUnknown status
Waterloo Regional Health Network (WRHN) ( Site 0117)
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KitchenerCanadaUnknown status
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
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MontrealCanadaUnknown status
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
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MontrealCanadaUnknown status
Stronach Regional Cancer Centre ( Site 0101)
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NewmarketCanadaUnknown status
Lions Gate Hospital ( Site 0106)
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North VancouverCanadaUnknown status
Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
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RimouskiCanadaUnknown status
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
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SherbrookeCanadaUnknown status
BC Cancer - Victoria ( Site 0109)
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VictoriaCanadaUnknown status
Clinica de la Costa S.A.S. ( Site 0608)
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BarranquillaColombiaUnknown status
Administradora Country S.A. ( Site 0603)
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BogotáColombiaUnknown status
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
Coordinator of this site? Confirm its status
BogotáColombiaUnknown status
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
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MedellínColombiaUnknown status
Universitätsklinikum Bonn Medizinische Klinik III für Hämatologie und Onkologie
Coordinator of this site? Confirm its status
BonnGermanyCompleted
HELIOS Klinikum Erfurt GmbH
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ErfurtGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
Lungenfachklinik Immenhausen
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ImmenhausenGermanyCompleted
Institut fuer Versorgungsforschung in der Onkologie GbR
Coordinator of this site? Confirm its status
KoblenzGermanyCompleted
Muenchen Klinik gGmbH
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MunichGermanyCompleted
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Klinikum Wuerzburg Mitte gGmbH
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WuerzburgGermanyCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier de Chauny
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ChaunyFranceCompleted
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceCompleted
Centre Hospitalier de Pau
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PauFranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Unite De Recherche Clinique HIA Begin
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Saint-MandeFranceCompleted
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceCompleted
Hopitaux Prives De Metz
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VantouxFranceCompleted
Birmingham Heartlands Hospital ( Site 1910)
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BirminghamUnited KingdomUnknown status
West Suffolk Hospitals NHS Trust ( Site 1919)
Coordinator of this site? Confirm its status
Bury St EdmundsUnited KingdomUnknown status
Colchester General Hospital ( Site 1911)
Coordinator of this site? Confirm its status
ColchesterUnited KingdomUnknown status
Western General Hospital, Edinburgh ( Site 1924)
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
Chelsea and Westminster Hospital ( Site 1901)
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
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LondonUnited KingdomUnknown status
Singleton Hospital ( Site 1909)
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SwanseaUnited KingdomUnknown status
National Hospital Organization Kyushu Medical Center ( Site 0805)
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FukuokaJapanUnknown status
Kansai Medical University Hospital ( Site 0804)
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HirakataJapanUnknown status
Kanazawa University Hospital ( Site 0811)
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KanazawaJapanUnknown status
National Cancer Center Hospital East ( Site 0801)
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KashiwaJapanUnknown status
Aichi Cancer Center ( Site 0803)
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NagoyaJapanUnknown status
National Hospital Organization Nagoya Medical Center ( Site 0806)
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NagoyaJapanUnknown status
Niigata Cancer Center Hospital ( Site 0808)
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NiigataJapanUnknown status
Okayama University Hospital ( Site 0810)
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OkayamaJapanUnknown status
Osaka International Cancer Institute ( Site 0809)
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OsakaJapanUnknown status
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
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SakaiJapanUnknown status
Sendai Kousei Hospital ( Site 0812)
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SendaiJapanUnknown status
Shizuoka Cancer Center ( Site 0802)
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SuntogunJapanUnknown status
Cancer Institute Hospital of JFCR ( Site 0800)
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TokyoJapanUnknown status
Kanagawa Cancer Center ( Site 0807)
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YokohamaJapanUnknown status
Chungbuk National University Hospital ( Site 1002)
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Cheongju-siSouth KoreaUnknown status
National Cancer Center ( Site 1006)
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Goyang-siSouth KoreaUnknown status
Gyeongsang National University Hospital ( Site 1005)
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JinjuSouth KoreaUnknown status
Seoul National University Hospital ( Site 1000)
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital ( Site 1008)
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SeoulSouth KoreaUnknown status
Asan Medical Center ( Site 1007)
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Songpa-guSouth KoreaUnknown status
Ajou University Hospital ( Site 1004)
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SuwonSouth KoreaUnknown status
The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
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SuwonSouth KoreaUnknown status
MidCentral DHB Palmerston North Hospital ( Site 1102)
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Palmerston NorthNew ZealandUnknown status
Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
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WellingtonNew ZealandUnknown status
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandCompleted
Przychodnia Lekarska "KOMED"
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KoninPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Med Polonia Sp z o.o.
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PoznanPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Memorial Healthcare International S R L
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BucharestRomaniaCompleted
CardioMed S.R.L.
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Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaCompleted
Ovidius Clinical Hospital S.R.L
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OvidiuRomaniaCompleted
Oncomed S.R.L.
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TimisoaraRomaniaCompleted
Moscow Regional Oncological Dispensary ( Site 2028)
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BalashikhaRussiaUnknown status
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 2021)
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Kazan'RussiaUnknown status
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
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MoscowRussiaUnknown status
First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
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MoscowRussiaUnknown status
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
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MoscowRussiaUnknown status
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
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MoscowRussiaUnknown status
Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
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Nizhny NovgorodRussiaUnknown status
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site 2010)
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OmskRussiaUnknown status
SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
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Saint PetersburgRussiaUnknown status
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
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Saint PetersburgRussiaUnknown status
SBHI Leningrad Regional Clinical Hospital ( Site 2002)
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Saint PetersburgRussiaUnknown status
SPb Central Clinical Railway Hospital ( Site 2003)
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Saint PetersburgRussiaUnknown status
SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
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SamaraRussiaUnknown status
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital ( Site 0904)
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital ( Site 0905)
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TainanTaiwanUnknown status
Mackay Memorial Hospital ( Site 0902)
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TaipeiTaiwanUnknown status
National Taiwan University Hospital ( Site 0900)
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
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TaoyuanTaiwanUnknown status
Cherkasy Regional Oncology Dispensary ( Site 2211)
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CherkasyUkraineUnknown status
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 2201)
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DniproUkraineUnknown status
MI Precarpathian Clinical Oncology Center ( Site 2204)
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Ivano-FrankivskUkraineUnknown status
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)
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KharkivUkraineUnknown status
CNPE "Regional Center of Oncology"-Thoracic organs ( Site 2205)
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KharkivUkraineUnknown status
Medical Center Asklepion LLC ( Site 2234)
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KhodosovkaUkraineUnknown status
PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)
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KropyvnitskiyUkraineUnknown status
Medical Center Verum ( Site 2230)
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KyivUkraineUnknown status
Kyiv City Clinical Oncology Centre ( Site 2210)
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KyivUkraineUnknown status
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)
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KyivUkraineUnknown status
MI Odessa Regional Oncological Centre ( Site 2208)
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OdesaUkraineUnknown status
Central City Clinical Hospital ( Site 2207)
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UzhhorodUkraineUnknown status
Medstar Good Samaritan Hospital ( Site 0040)
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BaltimoreUnited StatesUnknown status
Frontier Oncology ( Site 0080)
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BillingsUnited StatesUnknown status
Alabama Oncology Bruno Cancer Center ( Site 0001)
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BirminghamUnited StatesUnknown status
Boca Raton Regional Hospital ( Site 0018)
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Boca RatonUnited StatesUnknown status
Bozeman Health Deaconness Cancer Center ( Site 0046)
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BozemanUnited StatesUnknown status
Disney Family Cancer Center ( Site 0005)
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BurbankUnited StatesUnknown status
Waverly Hematology Oncology ( Site 0081)
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CaryUnited StatesUnknown status
Mount Sinai Hospital Medical Center ( Site 0032)
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ChicagoUnited StatesUnknown status
Columbus Regional Research Institute ( Site 0098)
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ColumbusUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute ( Site 0041)
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DetroitUnited StatesUnknown status
Hattiesburg Clinic ( Site 0045)
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HattiesburgUnited StatesUnknown status
Thompson Cancer Survival Center ( Site 2812)
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KnoxvilleUnited StatesUnknown status
University of Tennessee Medical Center Knoxville ( Site 0060)
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KnoxvilleUnited StatesUnknown status
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
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MerrillvilleUnited StatesUnknown status
Northwest Alabama Cancer Center, PC ( Site 0002)
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Muscle ShoalsUnited StatesUnknown status
Mid-Florida Cancer Centers ( Site 0022)
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Orange CityUnited StatesUnknown status
Oncology of Northshore ( Site 0033)
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Rolling MeadowsUnited StatesUnknown status
Cancer Care Northwest ( Site 0071)
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Spokane ValleyUnited StatesUnknown status
Moffitt Cancer Center ( Site 0024)
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TampaUnited StatesUnknown status
Renovatio Clinical ( Site 0062)
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The WoodlandsUnited StatesUnknown status
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
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AdanaTurkey (Türkiye)Unknown status
Gazi Universitesi Tip Fakultesi ( Site 2104)
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Sehir Hastanesi ( Site 2105)
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AnkaraTurkey (Türkiye)Unknown status
Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
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IstanbulTurkey (Türkiye)Unknown status
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
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IstanbulTurkey (Türkiye)Unknown status
Ege Universitesi Tip Fakultesi ( Site 2109)
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IzmirTurkey (Türkiye)Unknown status
Erciyes Universitesi Tip Fakultesi ( Site 2108)
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KayseriTurkey (Türkiye)Unknown status
Ondokuz Mayıs Universitesi-Oncology department ( Site 2106)
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SamsunTurkey (Türkiye)Unknown status
Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
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TekirdağTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.