Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008) Summary This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Has a predicted life expectancy of >3 months Exclusion Criteria: Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease Has received prior treatment for Small Cell Lung Cancer (SCLC) Is expected to require any other form of antineoplastic therapy for SCLC while on study Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has a known history of, or active, neurologic paraneoplastic syndrome Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of Hepatitis B or known active Hepatitis C virus infection Has had an allogenic tissue/solid organ transplant Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention Has symptomatic ascites or pleural effusion
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There are 129 Locations for this study
Los Angeles Hematology Oncology Medical Group ( Site 0006) Los Angeles California, 90017, United States
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Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) Boca Raton Florida, 33486, United States
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Fort Wayne Medical Oncology and Hematology ( Site 0013) Fort Wayne Indiana, 46804, United States
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Cancer and Hematology Centers of Western Michigan ( Site 0001) Grand Rapids Michigan, 49503, United States
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Hattiesburg Clinic Hematology/Oncology ( Site 0003) Hattiesburg Mississippi, 39401, United States
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Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) Lancaster Pennsylvania, 17604, United States
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Blue Ridge Cancer Care ( Site 0015) Blacksburg Virginia, 24060, United States
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University of Virginia Cancer Center ( Site 0019) Charlottesville Virginia, 22903, United States
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Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata Buenos Aires, 7600, Argentina
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Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) ABB Caba, C1199, Argentina
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Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) Buenos Aires Caba, C1431, Argentina
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Sanatorio Parque ( Site 0202) Rosario Santa Fe, 2000, Argentina
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Hospital Provincial del Centenario ( Site 0205) Rosario Santa Fe, 2002, Argentina
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Nepean Hospital ( Site 2700) Penrith New South Wales, 2747, Australia
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Calvary Mater Newcastle ( Site 2703) Waratah New South Wales, 2298, Australia
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Frankston Hospital-Oncology and Haematology ( Site 2702) Frankston Victoria, 3199, Australia
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Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) St Albans Victoria, 3021, Australia
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Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) Linz Oberosterreich, 4020, Austria
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Kepler Universitätsklinikum ( Site 0507) Linz Oberosterreich, 4021, Austria
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Medizinische Universität Graz ( Site 0504) Graz Steiermark, 8036, Austria
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Klinik Penzing-2. Lungenabteilung ( Site 0502) Vienna Wien, 1140, Austria
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Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) Wien , 1210, Austria
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Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) Kingston Ontario, K7L 2, Canada
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Lakeridge Health ( Site 0102) Oshawa Ontario, L1G 2, Canada
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Anhui Cancer Hospital ( Site 2915) Hefei Anhui, 23003, China
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Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) Beijing Beijing, 10014, China
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Beijing Peking Union Medical College Hospital ( Site 2921) Beijing Beijing, 10073, China
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Fujian Provincial Cancer Hospital-oncology department ( Site 2904) Fuzhou Fujian, 35001, China
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Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) Harbin Heilongjiang, 15000, China
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Henan Cancer Hospital ( Site 2916) Zhengzhou Henan, 45000, China
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Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912) Wuhan Hubei, 43002, China
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Hubei Cancer Hospital ( Site 2922) Wuhan Hubei, 43007, China
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Hunan Cancer Hospital ( Site 2907) Changsha Hunan, 41001, China
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The First Affiliated Hospital of Soochow University ( Site 2913) Suzhou Jiangsu, 21500, China
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Jilin Cancer Hospital-GCP office ( Site 2909) Changchun Jilin, 13000, China
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The First Hospital of Jilin University ( Site 2914) Changchun Jilin, 13002, China
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The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) Xi'an Shaanxi, 71006, China
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Shanghai Chest Hospital-Oncology department ( Site 2900) Shanghai Shanghai, 20003, China
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Fudan University Shanghai Cancer Center ( Site 2908) Shanghai Shanghai, 20003, China
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Sichuan Cancer hospital ( Site 2923) Chengdu Sichuan, 61004, China
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West China Hospital Sichuan University ( Site 2903) Chengdu Sichuan, 61004, China
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Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906) Hangzhou Zhejiang, 31001, China
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Zhejiang Cancer Hospital-Oncology ( Site 2919) Hangzhou Zhejiang, 31002, China
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Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700) Vaasa Pohjanmaa, 65130, Finland
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Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702) Oulu Pohjois-Pohjanmaa, 90220, Finland
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Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701) Turku Varsinais-Suomi, 20520, Finland
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Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805) Marseille Bouches-du-Rhone, 13915, France
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CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800) Toulouse Haute-Garonne, 31059, France
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Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané Limoges Haute-Vienne, 87042, France
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Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905) Heidelberg Baden-Wurttemberg, 69126, Germany
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Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907) Immenhausen Hessen, 34376, Germany
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Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901) Hannover Niedersachsen, 30625, Germany
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LungenClinic Grosshansdorf-Onkologie ( Site 0903) Grosshansdorf Schleswig-Holstein, 22927, Germany
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SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900) Gera Thuringen, 07548, Germany
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Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002) Athens Attiki, 115 2, Greece
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Sotiria Thoracic Diseases Hospital of Athens ( Site 1003) Athens Attiki, 11527, Greece
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Metropolitan Hospital ( Site 1001) Athens Attiki, 185 4, Greece
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University General Hospital of Heraklion ( Site 1004) Heraklion Irakleio, 711 1, Greece
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European Interbalkan Medical Center ( Site 1000) Thessaloniki , 57001, Greece
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Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105) Kecskemét Bacs-Kiskun, 6000, Hungary
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Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102) Gyor Gyor-Moson-Sopron, 9024, Hungary
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Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101) Törökbálint Pest, 2045, Hungary
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Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104) Kaposvár Somogy, 7400, Hungary
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Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201) Dublin , Dubli, Ireland
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Rambam Health Care Campus-Oncology ( Site 1301) Haifa , 31096, Israel
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Shaare Zedek Medical Center-Oncology ( Site 1300) Jerusalem , 91031, Israel
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Sheba Medical Center-ONCOLOGY ( Site 1302) Ramat Gan , 52656, Israel
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Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402) Naples Campania, 80131, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401) Milan Lombardia, 20133, Italy
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Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403) Rozzano Milano, 20089, Italy
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Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400) Rome Roma, 00144, Italy
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Aichi Cancer Center Hospital ( Site 3016) Nagoya Aichi, 464-8, Japan
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National Cancer Center Hospital East ( Site 3002) Kashiwa Chiba, 277-8, Japan
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National Hospital Organization Shikoku Cancer Center ( Site 3012) Matsuyama Ehime, 791-0, Japan
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Kurume University Hospital ( Site 3014) Kurume Fukuoka, 830-0, Japan
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National Hospital Organization Hokkaido Cancer Center ( Site 3015) Sapporo Hokkaido, 003-0, Japan
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Kanazawa University Hospital ( Site 3006) Kanazawa Ishikawa, 920-8, Japan
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Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004) Yokohama Kanagawa, 241-8, Japan
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Sendai Kousei Hospital ( Site 3001) Sendai Miyagi, 98008, Japan
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Niigata Cancer Center Hospital ( Site 3005) Niigata-shi Niigata, 951-8, Japan
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Kansai Medical University Hospital ( Site 3009) Hirakata Osaka, 573-1, Japan
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Shizuoka Cancer Center ( Site 3007) Nagaizumi Shizuoka, 411-8, Japan
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Japanese Foundation for Cancer Research ( Site 3003) Koto Tokyo, 135-8, Japan
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National Hospital Organization Kyushu Medical Center ( Site 3013) Fukuoka , 810-8, Japan
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Okayama University Hospital ( Site 3011) Okayama , 700-8, Japan
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Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800) Hwasun Jeonranamdo, 58128, Korea, Republic of
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Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801) Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of
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Chungnam national university hospital-Department of Internal Medicine ( Site 2802) Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
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Korea University Guro Hospital-Internal Medicine ( Site 2803) Seoul , , Korea, Republic of
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Klaipeda University Hospital-Oncology chemotherapy ( Site 1502) Klaipeda Klaipedos Miestas, 92288, Lithuania
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National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501) Vilnius Vilniaus Miestas, 08406, Lithuania
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Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500) Kaunas , LT-50, Lithuania
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Arké SMO S.A. de C.V. ( Site 0401) Mexico Distrito Federal, 06700, Mexico
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Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407) Guadalajara Jalisco, 44280, Mexico
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Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403) Guadalajara Jalisco, 44680, Mexico
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iCan Oncology Center Centro Medico AVE ( Site 0406) Monterrey Nuevo Leon, 64710, Mexico
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Centro de Investigacion Clinica de Oaxaca ( Site 0410) Oaxaca , 68020, Mexico
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Medische Centrum Leeuwarden ( Site 1619) Leeuwarden Fryslan, 8934 , Netherlands
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Ziekenhuis Rijnstate ( Site 1606) Arnhem Gelderland, 6815 , Netherlands
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Maastricht UMC+-Pulmonary disease ( Site 1602) Maastricht Limburg, 6229 , Netherlands
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Jeroen Bosch Hospital-Pulmonology ( Site 1605) Den Bosch Noord-Brabant, 5223 , Netherlands
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Isala, locatie Zwolle-Poli Longziekten ( Site 1612) Zwolle Overijssel, 8025 , Netherlands
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Erasmus Medisch Centrum ( Site 1621) Rotterdam Zuid-Holland, 3015 , Netherlands
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Martini Ziekenhuis ( Site 1618) Groningen , 9728 , Netherlands
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Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709) Siedlce Mazowieckie, 08-11, Poland
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier Warszawa Mazowieckie, 02-78, Poland
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Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703) Przemysl Podkarpackie, 37-70, Poland
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Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706) Prabuty Pomorskie, 82-55, Poland
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Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707) Bystra Slaskie, 43-36, Poland
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Przychodnia Lekarska KOMED ( Site 1701) Konin Wielkopolskie, 62-50, Poland
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Med-Polonia Sp. z o. o. ( Site 1710) Poznan Wielkopolskie, 60-69, Poland
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Champalimaud Foundation ( Site 1812) Lisbon Lisboa, 1400-, Portugal
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Hospital CUF Descobertas ( Site 1815) Lisbon Lisboa, 1998-, Portugal
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Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813) Porto , 4099-, Portugal
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MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905) București Bucuresti, 02234, Romania
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Centrul medical Focus ( Site 1903) București Bucuresti, 02254, Romania
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Cardiomed SRL Cluj-Napoca ( Site 1900) Cluj-Napoca Cluj, 40001, Romania
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Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102) Madrid Madrid, Comunidad De, 28041, Spain
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H.R.U Málaga - Hospital General-Oncology ( Site 2104) Málaga Malaga, 29011, Spain
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Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100) Barcelona , 08035, Spain
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Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103) Sevilla , 41009, Spain
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Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402) Bornova Izmir, 35100, Turkey
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I.E.U. Medical Point Hastanesi-Oncology ( Site 2408) Izmir, Karsiyaka Izmir, 35575, Turkey
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Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407) Adana , 01250, Turkey
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Hacettepe Universitesi-oncology hospital ( Site 2409) Ankara , 06230, Turkey
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Memorial Ankara Hastanesi-Medical Oncology ( Site 2406) Ankara , 06520, Turkey
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Ankara City Hospital-Medical Oncology ( Site 2403) Ankara , 06800, Turkey
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Medipol University Medical Faculty-oncology ( Site 2400) Istanbul , 34214, Turkey
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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401) Istanbul , 34722, Turkey
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The Christie-Clinical Research Facility ( Site 2607) Manchester England, M20 4, United Kingdom
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Mount Vernon Hospital ( Site 2602) Northwood Hillingdon, HA6 2, United Kingdom
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Heartlands Hospital-Oncology Research ( Site 2604) Birmingham , B9 5S, United Kingdom
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