Lung Cancer Clinical Trial

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Summary

The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook.
Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants.
Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.

Exclusion Criteria:

Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging [MRI]) within 28 days of randomization to document stability, even if there have been no changes in symptoms.
Have previously completed or withdrawn from this study or any other study investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

453

Study ID:

NCT02152631

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 229 Locations for this study

See Locations Near You

Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Clopton Clinic
Jonesboro Arkansas, 72401, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
City of Hope National Medical Center
Duarte California, 91010, United States
St Jude Medical Center
Fullerton California, 92835, United States
University of California - San Diego
La Jolla California, 92037, United States
Loma Linda University School of Medicine
Loma Linda California, 92354, United States
SMO TRIO -Translational Research
Los Angeles California, 90024, United States
UCLA Department of Medicine-Hematology/Oncology
Los Angeles California, 90095, United States
Cancer Care Associates
Redondo Beach California, 90277, United States
Dignity Health Care Institute
Sacramento California, 95816, United States
Central Coast Medical Oncology Corporation
Santa Monica California, 93454, United States
SMO Catholic Health Initiatives
Englewood Colorado, 80112, United States
Medical Oncology Hematology Consultants
Newark Delaware, 19713, United States
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton Florida, 33486, United States
Halifax Medical Center
Daytona Beach Florida, 32114, United States
Memorial Cancer Institute
Pembroke Pines Florida, 33028, United States
H Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Northeast Georgia Cancer Care, LLC
Athens Georgia, 30607, United States
Harbin Clinic
Rome Georgia, 30165, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Fort Wayne Oncology & Hematology
Fort Wayne Indiana, 46845, United States
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States
University of Iowa
Iowa City Iowa, 52242, United States
Cancer Center of Kansas, P.A.
Wichita Kansas, 67214, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
St Joseph Cancer Center
Lexington Kentucky, 40509, United States
University of Louisville
Louisville Kentucky, 40202, United States
Jewish Hospital
Louisville Kentucky, 40245, United States
National Cancer Institute
Bethesda Maryland, 20889, United States
Metro-West and Greater Boston CNS Research
Framingham Massachusetts, 01701, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Freeman Cancer Institute
Joplin Missouri, 64804, United States
Mercy Medical Research Institute
Springfield Missouri, 65807, United States
Billings Clinic Research Center
Billings Montana, 59101, United States
St. Francis Medical Center
Grand Island Nebraska, 68802, United States
Alegent Immanuel Cancer Center
Omaha Nebraska, 68122, United States
Oncology Hematology West
Omaha Nebraska, 68130, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Broome Oncology
Johnson City New York, 13790, United States
Weill Cornell Medical College
New York New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa Oklahoma, 74146, United States
Providence Cancer Center Oncology Hematology Care
Portland Oregon, 97213, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Roper St. Francis Healthcare
Charleston South Carolina, 29401, United States
Chattanooga Oncology Hematology Associates
Chattanooga Tennessee, 37404, United States
SMO Sarah Cannon Research Inst.
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research Center
Dallas Texas, 75230, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Columbia Basin Hematology & Oncology
Kennewick Washington, 99336, United States
Swedish Medical Center
Seattle Washington, 98104, United States
Cancer Care Northwest
Valley Washington, 99216, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Berazategui , B1884, Argentina
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Ciudad Autonoma Buenos Aires , 1025, Argentina
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Ciudad Autonoma Buenos Aires , 1093, Argentina
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Ciudad Autonoma Buenos Aires , C1181, Argentina
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Rosario , 2000, Argentina
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Rosario , S2000, Argentina
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Viedma , 8500, Argentina
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Graz , 8036, Austria
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Linz , 4020, Austria
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Linz , 4021, Austria
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Salzburg , 5020, Austria
Associação Hospital de Caridade Ijuí
Ijui , 98700, Brazil
Hospital Bruno Born
Lajeados , 95900, Brazil
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Porto Alegre , 90610, Brazil
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Rio De Janeiro , 20231, Brazil
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Salvador , 41253, Brazil
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Sao Jose Rio Preto , 15090, Brazil
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São Paulo , 01246, Brazil
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo , 01509, Brazil
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Calgary , T2N 4, Canada
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Edmonton , T6G 1, Canada
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Montreal , H2L 4, Canada
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Toronto , M4N 3, Canada
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Vancouver , V5Z 4, Canada
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Winnipeg , R3A 1, Canada
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Beijing , 10002, China
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Beijing , 10007, China
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Beijing , 10073, China
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Changchun , 13001, China
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Changzhou , 21300, China
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Chengdu , 61004, China
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Haikou , 57031, China
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Hang Zhou , 31002, China
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Hefei , 23000, China
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Nanning , 53002, China
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Shanghai , 20003, China
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Shenyang , 10004, China
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Bron , 69677, France
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Dijon , 21034, France
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Grenoble , 38043, France
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Lille , 59037, France
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Marseille , 13015, France
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Poitiers , 86021, France
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Rennes , 35033, France
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Saint-Brieuc , 22027, France
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St Priest en Jarez , 42270, France
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Toulouse , 31059, France
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Vantoux , 57070, France
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Berlin , 14165, Germany
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Gera , 07548, Germany
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Großhansdorf , 22927, Germany
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Hamburg , 21075, Germany
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Hannover , 30459, Germany
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Heidelberg , 69126, Germany
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Immenhausen , 34376, Germany
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Nürnberg , 90419, Germany
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Regensburg , 93053, Germany
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Rosenheim , 83022, Germany
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Tübingen , 72076, Germany
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Ulm , 89081, Germany
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Athens , 11522, Greece
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Athens , 11527, Greece
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Athens , 18537, Greece
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Heraklion , 71110, Greece
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Patras , 26504, Greece
Soroka Medical Center
Beer Sheva , 84101, Israel
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Holon , 58220, Israel
Hadassah Medical Center - Ein Karem
Jerusalem , 91120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
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Petah Tiqva , 49414, Israel
Sheba Medical Center
Tel Hashomer , 52656, Israel
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Catania , 95125, Italy
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Genova , 16132, Italy
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Livorno , 57124, Italy
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Parma , 43100, Italy
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Rome , 00152, Italy
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Amagasaki , 660-0, Japan
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Asahikawa , 070-8, Japan
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Bunkyo-ku , 113-8, Japan
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Bunkyo-Ku , 113-8, Japan
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Fukuoka , 811-1, Japan
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Habikino , 583-8, Japan
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Hirakata , 573-1, Japan
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Hiroshima , 734-8, Japan
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Hyogo , 66085, Japan
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Kanazawa , 920-8, Japan
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Kashiwa , 277 8, Japan
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Kishiwada , 596-8, Japan
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Kitaadachi-Gun , 362-0, Japan
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Kobe , 650-0, Japan
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Koto-ku , 135-8, Japan
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Kurashiki , 710-8, Japan
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Matsuyama , 791-0, Japan
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Nagasaki , 852-8, Japan
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Nagoya , 464-8, Japan
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Nagoya , 466-8, Japan
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Natori , 981-1, Japan
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Okayama , 700-8, Japan
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Osakasayama , 589-8, Japan
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Osaka , 534-0, Japan
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Osaka , 537-8, Japan
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Osaka , 545-8, Japan
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Sakai , 59185, Japan
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Sendai , 980-0, Japan
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Shinjuku-ku , 160-0, Japan
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Sunto-Gun , 411-8, Japan
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Ube , 755-0, Japan
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Utsunomiya , 320-0, Japan
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Wakayama , 641-8, Japan
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Yokohama , 236-0, Japan
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Yonago , 683-0, Japan
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Yufu-shi , 87955, Japan
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Goyang-Si , 10408, Korea, Republic of
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Incheon , 21565, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seowon-Gu , 28644, Korea, Republic of
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Suwon , 16247, Korea, Republic of
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Ulsan-si , 44033, Korea, Republic of
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Gdansk , 80-21, Poland
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Lodz , 90-24, Poland
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Olsztyn , 10-35, Poland
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Radom , 26-61, Poland
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Szczecin , 70-89, Poland
VA Caribbean Healthcare System
San Juan , 00921, Puerto Rico
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Baia Mare , 43003, Romania
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Bucharest , 02232, Romania
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Cluj-Napoca , 40001, Romania
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Cluj-Napoca , 40005, Romania
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Craiova , 20034, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk , 16304, Russian Federation
Private clinic "Evimed"
Chelyabinsk , 45404, Russian Federation
Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
Krasnodar , 35008, Russian Federation
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Kursk , 30503, Russian Federation
Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
Moscow , 11547, Russian Federation
St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg , 19825, Russian Federation
Republic clinical oncology dispensary of MoH of Bashkortostan Republic
Ufa , 45005, Russian Federation
Volgograd regional clinical oncology dispensary
Volzhskiy , 40413, Russian Federation
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Barcelona , 08003, Spain
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L'Hospitalet de Llobregat , 08907, Spain
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La Coruña , 15006, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Madrid , 28050, Spain
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Malaga , 29010, Spain
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Sevilla , 41013, Spain
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Valencia , 46026, Spain
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Chiayi , 613, Taiwan
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Jhonghe City , 235, Taiwan
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Kaohsiung City , 82445, Taiwan
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Kaohsiung , 83301, Taiwan
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Taichung City , 404, Taiwan
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Taichung , 40447, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 10449, Taiwan
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Taipei , 11217, Taiwan
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Ankara , 06100, Turkey
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Ankara , 06490, Turkey
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Antalya , 07059, Turkey
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Edirne , 22030, Turkey
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Istanbul , 34020, Turkey
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Istanbul , 34098, Turkey
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Istanbul , 34890, Turkey
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Izmir , 35100, Turkey
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Dnipropetrovsk , 49102, Ukraine
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Kharkiv , 61070, Ukraine
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Kriviy Rig , 50048, Ukraine
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Kyiv , 04107, Ukraine
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Lutsk , 63000, Ukraine
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Poltava , 36011, Ukraine
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Sumy , 40005, Ukraine
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Uzhhorod , 88000, Ukraine
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Vinnitsa , 21029, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

453

Study ID:

NCT02152631

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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