Lung Cancer Clinical Trial

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy
Prior bevacizumab as first-line and/or maintenance therapy is allowed
Signed informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Histologically or cytologically confirmed NSCLC
Stage IV NSCLC disease
Participants have measurable or nonmeasurable disease

Adequate organ function, defined as:

Total bilirubin less than or equal to Upper Limit of Normal (ULN),
Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,
Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection),
Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10^3/µL,
Adequate coagulation function as defined by International Normalized Ratio (INR) less than or equal to 1.5, or prothrombin time and partial thromboplastin time less than or equal to 1.5 x ULN.
The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+, a 24-hour urine must be collected and must demonstrate less than 1000 milligrams (mg) of protein.
Participants of reproductive potential (both sexes) must agree to use reliable method of birth control (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
Life expectancy of greater than or equal to 3 months
Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28 days have elapsed from the completion of radiation treatment prior to randomization; In the case of focal or palliative radiation treatment at least 7 days have elapsed from last radiation treatment prior to randomization (and provided that 25% or less of total bone marrow had been irradiated); In the case of Central Nervous System (CNS) radiation at least 14 days have elapsed from the completion of radiation treatment prior to randomization

Exclusion Criteria:

Disease progression on more than 1 prior chemotherapy regimens
Participants whose only prior treatment was a tyrosine kinase inhibitor
The participant's tumor wholly or partially contains small cell lung cancer
Major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months.
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy
Last dose of bevacizumab must be at least 28 days from time of randomization
Last dose of cytotoxic chemotherapy must be at least 14 days from time of randomization
The participant has untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or IV contrast Computed Tomography (CT) scan.
Radiologically documented evidence of major blood vessel invasion or encasement by cancer
Radiographic evidence of intratumor cavitation
History of uncontrolled hereditary or acquired thrombotic disorder
Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other antiplatelet agents; Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted
History of gross hemoptysis (defined as bright red blood or greater than or equal to 1/2 teaspoon) within 2 months prior to randomization
Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)] or symptomatic or poorly controlled cardiac arrhythmia
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 millimeters of mercury (mm Hg) despite standard medical management
Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization
Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to randomization
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
Peripheral neuropathy greater than or equal to Grade 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02]
Serious illness or medical condition(s) including, but not limited to: Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Known allergy or hypersensitivity reaction to any of the treatment components
The participant is pregnant or breastfeeding
Current or recent (within 28 days prior to randomization) treatment with an investigational drug or device that has not received regulatory approval for any indication at the time of randomization, or participation in another interventional clinical trial
Prior therapy with docetaxel

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1253

Study ID:

NCT01168973

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 231 Locations for this study

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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.
Phoenix Arizona, 85016, United States
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Sedona Arizona, 86336, United States
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Fayetteville Arkansas, 72703, United States
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Alhambra California, 91801, United States
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Duarte California, 91010, United States
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Fresno California, 93720, United States
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Fullerton California, 92835, United States
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La Jolla California, 92093, United States
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Long Beach California, 90813, United States
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Los Angeles California, 90095, United States
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Northridge California, 91325, United States
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Redondo Beach California, 90277, United States
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Santa Barbara California, 93105, United States
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Santa Monica California, 93454, United States
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Denver Colorado, 80218, United States
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Waterbury Connecticut, 06708, United States
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Jacksonville Florida, 32204, United States
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Miami Florida, 33176, United States
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Ocala Florida, 34471, United States
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Orlando Florida, 32806, United States
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Athens Georgia, 30607, United States
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Augusta Georgia, 30901, United States
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Lawrenceville Georgia, 30045, United States
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Macon Georgia, 31201, United States
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Rome Georgia, 30165, United States
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Savannah Georgia, 31405, United States
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Springfield Illinois, 62703, United States
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Bloomington Indiana, 47402, United States
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Cedar Rapids Iowa, 52402, United States
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Iowa City Iowa, 52242, United States
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Overland Park Kansas, 66210, United States
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Wichita Kansas, 67214, United States
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Ashland Kentucky, 41101, United States
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Mount Sterling Kentucky, 40353, United States
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Baton Rouge Louisiana, 70809, United States
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Metairie Louisiana, 70006, United States
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Bethesda Maryland, 20817, United States
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Chevy Chase Maryland, 20815, United States
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Boston Massachusetts, 02115, United States
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Danvers Massachusetts, 01923, United States
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Framingham Massachusetts, 01701, United States
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Newton Massachusetts, 02462, United States
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Ann Arbor Michigan, 48109, United States
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Minneapolis Minnesota, 55404, United States
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Columbia Missouri, 65201, United States
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Joplin Missouri, 64804, United States
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Saint Louis Missouri, 63110, United States
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Billings Montana, 59101, United States
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Henderson Nevada, 89169, United States
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Reno Nevada, 89502, United States
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Lebanon New Hampshire, 03756, United States
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Portsmouth New Hampshire, 03801, United States
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Albuquerque New Mexico, 87109, United States
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Bronx New York, 10467, United States
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Latham New York, 12110, United States
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New York New York, 10021, United States
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Durham North Carolina, 27704, United States
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Raleigh North Carolina, 27607, United States
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Fargo North Dakota, 58122, United States
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Columbus Ohio, 43219, United States
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Tulsa Oklahoma, 74136, United States
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Abington Pennsylvania, 19001, United States
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Kingston Pennsylvania, 18704, United States
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Philadelphia Pennsylvania, 19106, United States
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Charleston South Carolina, 29414, United States
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Sioux Falls South Dakota, 57104, United States
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Chattanooga Tennessee, 37403, United States
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Memphis Tennessee, 38138, United States
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Abilene Texas, 79606, United States
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Amarillo Texas, 79106, United States
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Beaumont Texas, 77702, United States
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Bedford Texas, 76022, United States
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Dallas Texas, 75231, United States
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El Paso Texas, 79915, United States
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Fort Worth Texas, 76104, United States
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Lewisville Texas, 75067, United States
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McAllen Texas, 78503, United States
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Mesquite Texas, 75150, United States
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Midland Texas, 79701, United States
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Odessa Texas, 79761, United States
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Paris Texas, 75460, United States
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San Antonio Texas, 78212, United States
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San Antonio Texas, 78229, United States
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Sherman Texas, 75090, United States
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Sugar Land Texas, 77479, United States
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The Woodlands Texas, 77380, United States
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Tyler Texas, 75702, United States
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Webster Texas, 77598, United States
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Wichita Falls Texas, 76310, United States
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Christiansburg Virginia, 24073, United States
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Fairfax Virginia, 22031, United States
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Newport News Virginia, 23601, United States
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Richmond Virginia, 23298, United States
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Lacey Washington, 98503, United States
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Spokane Washington, 99216, United States
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Wenatchee Washington, 98801, United States
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Madison Wisconsin, 53705, United States
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Buenos Aires , C1417, Argentina
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Córdoba , X5016, Argentina
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La Rioja , 5300, Argentina
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Rosario , 2000, Argentina
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Tucumain , 4000, Argentina
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Viedma , 8500, Argentina
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Graz , 8036, Austria
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Grimmenstein , 2840, Austria
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Vienna , A-114, Austria
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Wels , 4600, Austria
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Barretos , 14784, Brazil
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Belo Horizonte , 31110, Brazil
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Goiania , 74140, Brazil
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Porto Alegre , 90430, Brazil
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São Paulo , 12240, Brazil
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Edmonton Alberta, T6G 1, Canada
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Moncton New Brunswick, E1C 6, Canada
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Sainte-Foy Quebec, G1V 4, Canada
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Grenoble , 38049, France
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Lille , 59037, France
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Lyon , 69373, France
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Nice , 06050, France
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Strasbourg , 67091, France
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Toulouse , 31059, France
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Vandoeuvre Les Nancy , 54511, France
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Augsburg , 86150, Germany
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Bad Soden , 65812, Germany
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Bielefeld , 33611, Germany
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Dresden , 01307, Germany
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Frankfurt , 60596, Germany
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Gerlingen , 70839, Germany
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Großhansdorf , 22927, Germany
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Halle , 06120, Germany
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Heidelberg , 69126, Germany
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Immenhausen , 34376, Germany
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Oldenburg , 26121, Germany
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Ulm , 89081, Germany
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Villingen-Schwenningen , 78050, Germany
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Athens , 10676, Greece
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Chania , 73300, Greece
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Kifissia , 14564, Greece
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Patras , 26500, Greece
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Budapest , 1145, Hungary
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Gyula , 5703, Hungary
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Matrahaza , 3233, Hungary
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Nyiregyhaza , 4412, Hungary
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Pécs , 7623, Hungary
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Szekesfehervar , 8000, Hungary
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Bangalore , 56009, India
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Cuttack , 75300, India
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Delhi , 11008, India
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Jaipur , 30201, India
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Kochin , 62804, India
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Madurai , 62502, India
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Mumbai , 400 0, India
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Pune , 41100, India
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Trivandrum , 695 0, India
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Kfar Saba , 44281, Israel
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Petah Tikva , 49100, Israel
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Safed , 13110, Israel
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Tel-Aviv , 64239, Israel
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Livorno , 57124, Italy
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Monza , 20900, Italy
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Novara , 28100, Italy
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Padova , 35128, Italy
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Palermo , 90146, Italy
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Parma , 43100, Italy
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Pisa , 56124, Italy
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Rome , 00152, Italy
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Incheon , 405-7, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Suwon-City , 442-7, Korea, Republic of
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Guadalajara , 44280, Mexico
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Mexico City , 14000, Mexico
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Amsterdam , 1091A, Netherlands
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Arnhem , 6815 , Netherlands
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Harderwijk , 3844 , Netherlands
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S-Hertogenbosch , 5223 , Netherlands
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Zwolle , 80211, Netherlands
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Grafton , 1023, New Zealand
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Wellington , 6002, New Zealand
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Oslo , 0310, Norway
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Tromsø , 9012, Norway
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Gdansk , 80-21, Poland
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Gdynia , 81-51, Poland
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Glucholazy , 48-34, Poland
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Krakow , 31-20, Poland
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Lodz , 90-24, Poland
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Opole , 45-06, Poland
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Otwock , 05-40, Poland
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Poznan , 60-69, Poland
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Bayamon , 00959, Puerto Rico
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Bucharest , 02232, Romania
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Cluj-Napoca , 40005, Romania
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Iasi , 70010, Romania
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Moscow , 11547, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Stavropol , 35504, Russian Federation
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Barcelona , 08003, Spain
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Girona , 17007, Spain
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Las Palmas De Gran Canaria , 35016, Spain
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Madrid , 28050, Spain
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Mataró , 08304, Spain
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Pamplona , 31008, Spain
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Pozuelo De Alarcon , 28223, Spain
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Eskilstuna , 63188, Sweden
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Linkoping , 58185, Sweden
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Lund , 22185, Sweden
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Solna , 17176, Sweden
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Basel , CH-40, Switzerland
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Bern , CH-30, Switzerland
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Fribourg , 1708, Switzerland
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Luzern , CH-60, Switzerland
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Zurich , CH-80, Switzerland
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Kaohsiung , 813, Taiwan
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Kuei Shan Hsiang , 33305, Taiwan
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Neihu Taipei , 114, Taiwan
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Niao Sung Hsiang , 833, Taiwan
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Taichung , 40705, Taiwan
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Taipei , 11031, Taiwan
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Ankara , 06500, Turkey
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Istanbul , 81540, Turkey
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Izmir , 35340, Turkey
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Kayseri , 38039, Turkey
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Cottingham East Yorkshire, HU16 , United Kingdom
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London Greater London, W6 8R, United Kingdom
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Preston Lancashire, PR2 9, United Kingdom
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Wythenshawe Manchester, M23 9, United Kingdom
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Scunthorpe North Lincolnshire, DN15 , United Kingdom
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Glasgow Scotland, G12 0, United Kingdom
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Coventry West Midlands, CV2 2, United Kingdom
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Wolverhampton West Midlands, WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1253

Study ID:

NCT01168973

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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