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En undersøgelse af kemoterapi og ramucirumab versus kemoterapi alene i anden linje ikke-småcellet lungekræft (NSCLC)-deltagere, der har modtaget tidligere førstelinje-platinbaseret kemoterapi

10. september 2019 opdateret af: Eli Lilly and Company

Et randomiseret, dobbeltblindt fase 3-studie af docetaxel og ramucirumab versus docetaxel og placebo til behandling af ikke-småcellet lungekræft i trin IV efter sygdomsprogression efter én tidligere platinbaseret terapi

Formålet med undersøgelsen er at sammenligne overlevelsen af ​​deltagere, der modtager kemoterapi og ramucirumab, versus kemoterapi alene som andenlinjebehandling for NSCLC efter tidligere førstelinjes platinbaseret kemoterapi.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1253

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Buenos Aires, Argentina, C1417EYG
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      • Córdoba, Argentina, X5016KEH
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      • La Rioja, Argentina, 5300
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      • Rosario, Argentina, 2000
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      • Tucumain, Argentina, 4000
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      • Viedma, Argentina, 8500
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      • Barretos, Brasilien, 14784700
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      • Belo Horizonte, Brasilien, 31110580
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      • Goiania, Brasilien, 74140050
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      • Porto Alegre, Brasilien, 90430-090
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      • São Paulo, Brasilien, 1224010
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    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
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    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
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    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 4G5
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      • Moscow, Den Russiske Føderation, 115478
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      • Saint Petersburg, Den Russiske Føderation, 197758
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      • Stavropol, Den Russiske Føderation, 355047
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    • East Yorkshire
      • Cottingham, East Yorkshire, Det Forenede Kongerige, HU16 5JQ
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    • Greater London
      • London, Greater London, Det Forenede Kongerige, W6 8RF
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    • Lancashire
      • Preston, Lancashire, Det Forenede Kongerige, PR2 9HT
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    • Manchester
      • Wythenshawe, Manchester, Det Forenede Kongerige, M23 9LT
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    • North Lincolnshire
      • Scunthorpe, North Lincolnshire, Det Forenede Kongerige, DN15 7BH
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    • Scotland
      • Glasgow, Scotland, Det Forenede Kongerige, G12 0YN
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    • West Midlands
      • Coventry, West Midlands, Det Forenede Kongerige, CV2 2DX
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      • Wolverhampton, West Midlands, Det Forenede Kongerige, WV10 0QP
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    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
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      • Sedona, Arizona, Forenede Stater, 86336
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    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
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    • California
      • Alhambra, California, Forenede Stater, 91801
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      • Duarte, California, Forenede Stater, 91010
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      • Fresno, California, Forenede Stater, 93720
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      • Fullerton, California, Forenede Stater, 92835
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      • La Jolla, California, Forenede Stater, 92093
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      • Long Beach, California, Forenede Stater, 90813
        • 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.
      • Los Angeles, California, Forenede Stater, 90095
        • 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.
      • Northridge, California, Forenede Stater, 91325
        • 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.
      • Redondo Beach, California, Forenede Stater, 90277
        • 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.
      • Santa Barbara, California, Forenede Stater, 93105
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      • Santa Monica, California, Forenede Stater, 93454
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    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • 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.
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • 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.
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
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      • Miami, Florida, Forenede Stater, 33176
        • 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.
      • Ocala, Florida, Forenede Stater, 34471
        • 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.
      • Orlando, Florida, Forenede Stater, 32806
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    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • 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.
      • Augusta, Georgia, Forenede Stater, 30901
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      • Lawrenceville, Georgia, Forenede Stater, 30045
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      • Macon, Georgia, Forenede Stater, 31201
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      • Rome, Georgia, Forenede Stater, 30165
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      • Savannah, Georgia, Forenede Stater, 31405
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    • Illinois
      • Springfield, Illinois, Forenede Stater, 62703
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    • Indiana
      • Bloomington, Indiana, Forenede Stater, 47402
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    • Iowa
      • Cedar Rapids, Iowa, Forenede Stater, 52402
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      • Iowa City, Iowa, Forenede Stater, 52242
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    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66210
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      • Wichita, Kansas, Forenede Stater, 67214
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    • Kentucky
      • Ashland, Kentucky, Forenede Stater, 41101
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      • Mount Sterling, Kentucky, Forenede Stater, 40353
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    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
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      • Metairie, Louisiana, Forenede Stater, 70006
        • 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.
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
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      • Chevy Chase, Maryland, Forenede Stater, 20815
        • 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.
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
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      • Danvers, Massachusetts, Forenede Stater, 01923
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      • Framingham, Massachusetts, Forenede Stater, 01701
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      • Newton, Massachusetts, Forenede Stater, 02462
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    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
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    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
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    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
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      • Joplin, Missouri, Forenede Stater, 64804
        • 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.
      • Saint Louis, Missouri, Forenede Stater, 63110
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    • Montana
      • Billings, Montana, Forenede Stater, 59101
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    • Nevada
      • Henderson, Nevada, Forenede Stater, 89169
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      • Reno, Nevada, Forenede Stater, 89502
        • 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.
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
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      • Portsmouth, New Hampshire, Forenede Stater, 03801
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    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • 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.
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • 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.
      • Latham, New York, Forenede Stater, 12110
        • 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.
      • New York, New York, Forenede Stater, 10021
        • 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.
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27704
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      • Raleigh, North Carolina, Forenede Stater, 27607
        • 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.
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
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    • Ohio
      • Columbus, Ohio, Forenede Stater, 43219
        • 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.
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • 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.
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • 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.
      • Kingston, Pennsylvania, Forenede Stater, 18704
        • 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.
      • Philadelphia, Pennsylvania, Forenede Stater, 19106
        • 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.
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29414
        • 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.
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • 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.
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • 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.
      • Memphis, Tennessee, Forenede Stater, 38138
        • 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.
    • Texas
      • Abilene, Texas, Forenede Stater, 79606
        • 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.
      • Amarillo, Texas, Forenede Stater, 79106
        • 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.
      • Beaumont, Texas, Forenede Stater, 77702
        • 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.
      • Bedford, Texas, Forenede Stater, 76022
        • 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.
      • Dallas, Texas, Forenede Stater, 75231
        • 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.
      • El Paso, Texas, Forenede Stater, 79915
        • 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.
      • Fort Worth, Texas, Forenede Stater, 76104
        • 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.
      • Lewisville, Texas, Forenede Stater, 75067
        • 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.
      • McAllen, Texas, Forenede Stater, 78503
        • 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.
      • Mesquite, Texas, Forenede Stater, 75150
        • 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.
      • Midland, Texas, Forenede Stater, 79701
        • 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.
      • Odessa, Texas, Forenede Stater, 79761
        • 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.
      • Paris, Texas, Forenede Stater, 75460
        • 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.
      • San Antonio, Texas, Forenede Stater, 78229
        • 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.
      • San Antonio, Texas, Forenede Stater, 78212
        • 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.
      • Sherman, Texas, Forenede Stater, 75090
        • 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.
      • Sugar Land, Texas, Forenede Stater, 77479
        • 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.
      • The Woodlands, Texas, Forenede Stater, 77380
        • 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.
      • Tyler, Texas, Forenede Stater, 75702
        • 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.
      • Webster, Texas, Forenede Stater, 77598
        • 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.
      • Wichita Falls, Texas, Forenede Stater, 76310
        • 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.
    • Virginia
      • Christiansburg, Virginia, Forenede Stater, 24073
        • 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.
      • Fairfax, Virginia, Forenede Stater, 22031
        • 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.
      • Newport News, Virginia, Forenede Stater, 23601
        • 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.
      • Richmond, Virginia, Forenede Stater, 23298
        • 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.
    • Washington
      • Lacey, Washington, Forenede Stater, 98503
        • 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.
      • Spokane, Washington, Forenede Stater, 99216
        • 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.
      • Wenatchee, Washington, Forenede Stater, 98801
        • 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.
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • 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.
      • Grenoble, Frankrig, 38049
        • 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.
      • Lille, Frankrig, 59037
        • 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.
      • Lyon, Frankrig, 69373
        • 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.
      • Nice, Frankrig, 06050
        • 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.
      • Strasbourg, Frankrig, 67091
        • 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.
      • Toulouse, Frankrig, 31059
        • 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.
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • 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.
      • Athens, Grækenland, 10676
        • 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.
      • Chania, Grækenland, 73300
        • 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.
      • Kifissia, Grækenland, 14564
        • 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.
      • Patras, Grækenland, 26500
        • 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.
      • Amsterdam, Holland, 1091AC
        • 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.
      • Arnhem, Holland, 6815 AD
        • 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.
      • Harderwijk, Holland, 3844 DG
        • 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.
      • S-Hertogenbosch, Holland, 5223 GZ
        • 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.
      • Zwolle, Holland, 80211 JW
        • 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.
      • Bangalore, Indien, 560099
        • 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.
      • Cuttack, Indien, 753007
        • 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.
      • Delhi, Indien, 110085
        • 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.
      • Jaipur, Indien, 302017
        • 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.
      • Kochin, Indien, 628040
        • 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.
      • Madurai, Indien, 625020
        • 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.
      • Mumbai, Indien, 400 012
        • 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.
      • Pune, Indien, 411001
        • 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.
      • Trivandrum, Indien, 695 011
        • 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.
      • Haifa, Israel, 31096
        • 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.
      • Jerusalem, Israel, 91120
        • 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.
      • Kfar Saba, Israel, 44281
        • 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.
      • Petah Tikva, Israel, 49100
        • 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.
      • Safed, Israel, 13110
        • 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.
      • Tel-Aviv, Israel, 64239
        • 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.
      • Livorno, Italien, 57124
        • 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.
      • Monza, Italien, 20900
        • 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.
      • Novara, Italien, 28100
        • 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.
      • Padova, Italien, 35128
        • 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.
      • Palermo, Italien, 90146
        • 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.
      • Parma, Italien, 43100
        • 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.
      • Pisa, Italien, 56124
        • 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.
      • Rome, Italien, 00152
        • 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.
      • Ankara, Kalkun, 06500
        • 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.
      • Istanbul, Kalkun, 81540
        • 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.
      • Izmir, Kalkun, 35340
        • 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.
      • Kayseri, Kalkun, 38039
        • 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.
      • Incheon, Korea, Republikken, 405-760
        • 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.
      • Seoul, Korea, Republikken, 120-752
        • 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.
      • Suwon-City, Korea, Republikken, 442-723
        • 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.
      • Guadalajara, Mexico, 44280
        • 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.
      • Mexico City, Mexico, 14000
        • 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.
      • Grafton, New Zealand, 1023
        • 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.
      • Wellington, New Zealand, 6002
        • 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.
      • Oslo, Norge, 0310
        • 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.
      • Tromsø, Norge, 9012
        • 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.
      • Gdansk, Polen, 80-219
        • 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.
      • Gdynia, Polen, 81-519
        • 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.
      • Glucholazy, Polen, 48-340
        • 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.
      • Krakow, Polen, 31-202
        • 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.
      • Lodz, Polen, 90-242
        • 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.
      • Opole, Polen, 45-060
        • 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.
      • Otwock, Polen, 05-400
        • 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.
      • Poznan, Polen, 60-693
        • 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.
      • Bayamon, Puerto Rico, 00959
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      • Bucharest, Rumænien, 022328
        • 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.
      • Cluj-Napoca, Rumænien, 400058
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      • Iasi, Rumænien, 700106
        • 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.
      • Basel, Schweiz, CH-4031
        • 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.
      • Bern, Schweiz, CH-3010
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      • Fribourg, Schweiz, 1708
        • 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.
      • Luzern, Schweiz, CH-6000
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      • Zurich, Schweiz, CH-8091
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      • Barcelona, Spanien, 08003
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      • Girona, Spanien, 17007
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      • Las Palmas De Gran Canaria, Spanien, 35016
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      • Madrid, Spanien, 28050
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      • Mataró, Spanien, 08304
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      • Pamplona, Spanien, 31008
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      • Pozuelo De Alarcon, Spanien, 28223
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      • Eskilstuna, Sverige, 63188
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      • Linkoping, Sverige, 58185
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      • Lund, Sverige, 22185
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      • Solna, Sverige, 17176
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      • Kaohsiung, Taiwan, 813
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      • Kuei Shan Hsiang, Taiwan, 33305
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      • Neihu Taipei, Taiwan, 114
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      • Niao Sung Hsiang, Taiwan, 833
        • 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.
      • Taichung, Taiwan, 40705
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      • Taipei, Taiwan, 11031
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      • Augsburg, Tyskland, 86150
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      • Bad Soden, Tyskland, 65812
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      • Bielefeld, Tyskland, 33611
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      • Dresden, Tyskland, 01307
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      • Frankfurt, Tyskland, 60596
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      • Gerlingen, Tyskland, 70839
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      • Großhansdorf, Tyskland, 22927
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      • Halle, Tyskland, 06120
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      • Heidelberg, Tyskland, 69126
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      • Immenhausen, Tyskland, 34376
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      • Oldenburg, Tyskland, 26121
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      • Ulm, Tyskland, 89081
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      • Villingen-Schwenningen, Tyskland, 78050
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      • Budapest, Ungarn, 1145
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      • Gyula, Ungarn, 5703
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      • Matrahaza, Ungarn, 3233
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      • Nyiregyhaza, Ungarn, 4412
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      • Pécs, Ungarn, 7623
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      • Szekesfehervar, Ungarn, 8000
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      • Graz, Østrig, 8036
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      • Grimmenstein, Østrig, 2840
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      • Vienna, Østrig, A-1140
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      • Wels, Østrig, 4600
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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Sygdomsprogression under eller efter en tidligere førstelinjes platinbaseret kemoterapi med eller uden vedligeholdelsesbehandling
  • Forudgående bevacizumab som førstelinje- og/eller vedligeholdelsesbehandling er tilladt
  • Underskrevet informeret samtykke
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0-1
  • Histologisk eller cytologisk bekræftet NSCLC
  • Stadie IV NSCLC sygdom
  • Deltagerne har målbar eller ikke-målbar sygdom
  • Tilstrækkelig organfunktion, defineret som:

    • Total bilirubin mindre end eller lig med øvre normalgrænse (ULN),
    • Aspartat Aminotransferase (AST) og Alanine Aminotransaminase (ALT) mindre end eller lig med 2,5 x ULN, eller mindre end eller lig med 5 x ULN, hvis transferaseforhøjelsen skyldes levermetastaser,
    • Serumkreatinin mindre end eller lig med 1,5 x ULN eller beregnet kreatininclearance større end eller lig med 50 milliliter pr. minut (ml/min) (i henhold til Cockcroft-Gault-formlen eller tilsvarende og/eller 24-timers urinopsamling),
    • Absolut neutrofiltal (ANC) større end eller lig med 1,5 x 10^3/mikroliter (µL), hæmoglobin større end eller lig med 10,0 gram/deciliter (g/dL), og blodplader større end eller lig med 100 x 10^3 /µL,
    • Tilstrækkelig koagulationsfunktion som defineret ved International Normalized Ratio (INR) mindre end eller lig med 1,5, eller protrombintid og partiel tromboplastintid mindre end eller lig med 1,5 x ULN.
    • Deltageren har ikke skrumpelever på et niveau af Child-Pugh B (eller værre) eller skrumpelever (i nogen grad) og en historie med hepatisk encefalopati eller klinisk betydningsfuld ascites som følge af skrumpelever. Klinisk meningsfuld ascites er defineret som ascites, der er et resultat af cirrhose og kræver løbende behandling med diuretika og/eller paracentese.
  • Urinprotein er mindre end eller lig med 1+ på målepind eller rutinemæssig urinanalyse. Hvis urinpinde eller rutineanalyse indikerer proteinuri større end eller lig med 2+, skal der opsamles en 24-timers urin og skal vise mindre end 1000 milligram (mg) protein.
  • Deltagere med reproduktionspotentiale (begge køn) skal acceptere at bruge pålidelig præventionsmetode (hormonelle eller barrieremetoder) i løbet af undersøgelsesperioden og mindst 12 uger efter den sidste dosis af undersøgelsesterapien
  • Forventet levetid på mere end eller lig med 3 måneder
  • Forudgående strålebehandling er tilladt, hvis: I tilfælde af thoraxstrålebehandling er der gået mindst 28 dage fra afslutning af strålebehandling før randomisering; I tilfælde af fokal eller palliativ strålebehandling er der gået mindst 7 dage fra sidste strålebehandling før randomisering (og forudsat at 25 % eller mindre af den samlede knoglemarv var blevet bestrålet); I tilfælde af stråling fra centralnervesystemet (CNS) er der gået mindst 14 dage fra afslutning af strålebehandling før randomisering

Ekskluderingskriterier:

  • Sygdomsprogression på mere end 1 tidligere kemoterapiregimer
  • Deltagere, hvis eneste tidligere behandling var en tyrosinkinasehæmmer
  • Deltagerens tumor indeholder helt eller delvist småcellet lungekræft
  • Større operation inden for 28 dage før randomisering eller placering af subkutan venøs adgangsenhed inden for 7 dage før randomisering. Postoperative blødningskomplikationer eller sårkomplikationer fra et kirurgisk indgreb udført inden for de sidste 2 måneder.
  • Samtidig behandling med anden kræftbehandling, herunder anden kemoterapi, immunterapi, hormonbehandling, kemoembolisering eller målrettet terapi
  • Sidste dosis af bevacizumab skal være mindst 28 dage fra tidspunktet for randomisering
  • Sidste dosis af cytotoksisk kemoterapi skal være mindst 14 dage fra tidspunktet for randomisering
  • Deltageren har ubehandlede CNS-metastaser. Deltagere med behandlede hjernemetastaser er kvalificerede, hvis de er klinisk stabile med hensyn til neurologisk funktion, off steroider efter kraniebestråling, der slutter mindst 2 uger før randomisering, eller efter kirurgisk resektion udført mindst 28 dage før randomisering. Ingen tegn på grad større end eller lig med 1 CNS-blødning baseret på forbehandling magnetisk resonansbilleddannelse (MRI) eller IV-kontrastcomputertomografi (CT) scanning.
  • Radiologisk dokumenteret tegn på større blodkarinvasion eller indkapsling af kræft
  • Radiografisk bevis på intratumor kavitation
  • Anamnese med ukontrolleret arvelig eller erhvervet trombotisk lidelse
  • Kronisk terapi med ikke-steroide antiinflammatoriske lægemidler (NSAID'er) eller andre antiblodplademidler; Aspirinbrug i doser op til 325 milligram pr. dag (mg/dag) er tilladt
  • Anamnese med grov hæmotyse (defineret som lyserødt blod eller større end eller lig med 1/2 teskefuld) inden for 2 måneder før randomisering
  • Klinisk relevant kongestiv hjerteinsufficiens [New York Heart Association (NYHA II-IV)] eller symptomatisk eller dårligt kontrolleret hjertearytmi
  • Enhver arteriel trombotisk hændelse, inklusive myokardieinfarkt, ustabil angina, cerebrovaskulær ulykke eller forbigående iskæmisk anfald inden for 6 måneder før randomisering
  • Ukontrolleret arteriel hypertension større end eller lig med 150 / større end eller lig med 90 millimeter kviksølv (mm Hg) på trods af standard medicinsk behandling
  • Alvorlige eller ikke-helende sår, mavesår eller knoglebrud inden for 28 dage før randomisering
  • Betydelige blødningsforstyrrelser, vaskulitis eller grad 3/4 gastrointestinal blødning inden for 3 måneder før randomisering
  • Gastrointestinal (GI) perforation og/eller fistler inden for 6 måneder før randomisering
  • Tarmobstruktion, historie eller tilstedeværelse af inflammatorisk enteropati eller omfattende tarmresektion Crohns sygdom, colitis ulcerosa eller kronisk diarré
  • Perifer neuropati større end eller lig med grad 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02]
  • Alvorlig sygdom eller medicinsk(e) tilstand(er), herunder, men ikke begrænset til: Human immundefektvirus (HIV) infektion eller erhvervet immundefekt syndrom (AIDS)-relateret sygdom; Aktiv eller ukontrolleret klinisk alvorlig infektion; Alvorlig akut eller kronisk medicinsk eller psykiatrisk tilstand eller laboratorieabnormitet, der kan øge risikoen forbundet med studiedeltagelse eller administration af studiemedicin
  • Kendt allergi- eller overfølsomhedsreaktion over for nogen af ​​behandlingskomponenterne
  • Deltageren er gravid eller ammer
  • Aktuel eller nylig (inden for 28 dage før randomisering) behandling med et forsøgslægemiddel eller udstyr, der ikke har modtaget myndighedsgodkendelse for nogen indikation på tidspunktet for randomiseringen eller deltagelse i et andet interventionelt klinisk forsøg
  • Tidligere behandling med docetaxel

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ramucirumab + Docetaxel
10 milligram pr. kilogram (mg/kg) administreret intravenøst ​​(IV) på dag 1 i 21-dages cyklus, indtil sygdomsprogression, uacceptabel toksicitet eller et andet tilbagetrækningskriterium er opfyldt
Andre navne:
  • LY3009806
  • IMC 1121B
75 milligram pr. kvadratmeter (mg/m^2) (60 mg/m^2 kun for landene Korea og Taiwan med protokolændring dateret 22. maj 2012) administreret IV på dag 1 i 21-dages cyklus indtil sygdomsprogression, uacceptabelt toksicitet, eller et andet tilbagetrækningskriterium er opfyldt
Placebo komparator: Placebo + Docetaxel
75 milligram pr. kvadratmeter (mg/m^2) (60 mg/m^2 kun for landene Korea og Taiwan med protokolændring dateret 22. maj 2012) administreret IV på dag 1 i 21-dages cyklus indtil sygdomsprogression, uacceptabelt toksicitet, eller et andet tilbagetrækningskriterium er opfyldt
Indgivet IV på dag 1 af 21-dages cyklus indtil sygdomsprogression, uacceptabel toksicitet eller et andet seponeringskriterium er opfyldt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Randomisering til dødsdato uanset årsag (op til 34 måneder)
Samlet overlevelse var tiden fra randomisering til datoen for dødsfald uanset årsag. Deltagere, der var i live ved slutningen af ​​opfølgningsperioden (eller mistede til opfølgning), blev censureret på den sidste dato, hvor deltageren vidstes at være i live.
Randomisering til dødsdato uanset årsag (op til 34 måneder)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelsestid (PFS).
Tidsramme: Randomisering til målt PD eller dødsdato uanset årsag (op til 29 måneder)
PFS-tid var tiden fra randomisering til datoen for objektivt bestemt progressiv sygdom (PD) eller død på grund af en hvilken som helst årsag, alt efter hvad der indtrådte først. Ifølge responsevalueringskriterier i solide tumorer version 1.1 (RECIST v1.1) var PD en stigning på mindst 20 % i summen af ​​diametrene af mållæsioner, idet man tog den mindste sum i undersøgelsen som reference. Ud over de 20 % relative stigning skal summen også have vist en absolut stigning på mindst 5 millimeter (mm). Forekomsten af ​​1 eller flere nye læsioner og/eller utvetydig progression af eksisterende non-target læsioner blev også betragtet som progression. Deltagere uden objektivt bestemt PD, som var i live ved slutningen af ​​opfølgningsperioden (eller mistede til opfølgning), blev censureret på datoen for deltagerens sidste komplette radiografiske tumorvurdering; hvis der ikke var nogen baseline eller post-baseline radiologisk vurdering tilgængelig, blev deltageren censureret på datoen for randomiseringen.
Randomisering til målt PD eller dødsdato uanset årsag (op til 29 måneder)
Procentdel af deltagere, der opnår en objektiv respons (objektiv responsrate)
Tidsramme: Baseline til målt PD (op til 29 måneder)
Deltagerne opnåede en objektiv respons, hvis de havde den bedste overordnede respons på delvis respons (PR) eller komplet respons (CR). Ifølge RECIST v1.1 blev PR defineret som et fald på mindst 30 % i summen af ​​diametrene af mållæsioner (inklusive de korte akser af enhver mållymfeknude), idet baseline-sumdiameteren blev taget som reference; CR var forsvinden af ​​alle ikke-nodale mållæsioner, med de korte akser af enhver mållymfeknude reduceret til <10 mm, forsvinden af ​​alle non-target læsioner og normaliseringen af ​​tumormarkørniveauer [hvis tumormarkører oprindeligt var over den øvre normalgrænse (ULN)]. Procentdelen af ​​deltagere, der opnåede en objektiv respons=(antal deltagere med CR eller PR)/(antal deltagere vurderet)*100.
Baseline til målt PD (op til 29 måneder)
Procentdel af deltagere, der opnår sygdomskontrol (hyppighed for sygdomsbekæmpelse)
Tidsramme: Baseline til målt PD (op til 29 måneder)
Deltagerne opnåede sygdomskontrol, hvis de havde den bedste overordnede respons på PR, CR eller stabil sygdom (SD). Ifølge RECIST v1.1 blev PR defineret som et fald på mindst 30 % i summen af ​​diametrene af mållæsioner (inklusive de korte akser af enhver mållymfeknude), idet baseline-sumdiameteren blev taget som reference; CR var forsvinden af ​​alle ikke-nodale mållæsioner, med de korte akser af enhver mållymfeknude reduceret til <10 mm, forsvinden af ​​alle non-target læsioner og normaliseringen af ​​tumormarkørniveauer (hvis tumormarkører oprindeligt var over ULN) ). SD var hverken tilstrækkeligt svind til at kvalificere som PR eller tilstrækkelig stigning til at kvalificere som PD, idet man tog som reference den mindste sumdiameter siden behandlingen startede. Procentdelen af ​​deltagere, der opnåede sygdomskontrol=(antal deltagere med CR, PR eller SD)/(antal vurderede deltagere)*100.
Baseline til målt PD (op til 29 måneder)
Maksimal forbedring på Lung Cancer Symptom Scale (LCSS)
Tidsramme: Baseline, dag 21 i hver cyklus og 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
LCSS bestod af 9 punkter: 6 punkter fokuserede på lungekræftsymptomer [tab af appetit, træthed, hoste, dyspnø (åndetnød), hæmoptyse (blod i sputum) og smerter] og 3 punkter var globale punkter (symptombesvær, forstyrrelse af aktivitetsniveau og global livskvalitet). Deltagersvar på hvert emne blev målt ved hjælp af visuelle analoge skalaer (VAS) med 100 mm linjer. En højere score for ethvert emne repræsenterede et højere niveau af symptomer/problemer. Det gennemsnitlige symptombyrdeindeks (ASBI) var gennemsnittet af de 6 symptomelementer i LCSS, og Total LCSS var gennemsnittet af alle 9 LCSS-elementer. ASBI og Total LCSS blev ikke beregnet for en deltager, hvis han/hun havde 1 eller flere manglende værdier for henholdsvis 6 og 9 elementer. Maksimal forbedring i LCSS-score, ASBI og Total LCSS-score var det største fald fra baseline for hver variabel, som var den mindste (mest negative eller mindste positive) ikke-manglende værdi blandt alle ændringer fra basislinjeværdier for hver variabel.
Baseline, dag 21 i hver cyklus og 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
Skift fra baseline til 30-dages opfølgningsbesøg på European Quality of Life Questionnaire-5 Dimension (EQ-5D) Sundhedsresultater
Tidsramme: Baseline, 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
EQ-5D er et livskvalitetsinstrument, der består af 2 dele. Den første del (Health State Index score) gav deltagerne mulighed for at vurdere deres helbredstilstand i 5 sundhedsdomæner: mobilitet, egenomsorg, sædvanlige aktiviteter, smerte/ubehag og angst/depression ved hjælp af en skala fra 1 til 3 (ingen problem, nogle henholdsvis problemer og ekstreme problemer). Disse kombinationer af attributter blev konverteret til en vægtet Health State Index-score ifølge en befolkningsbaseret algoritme i Storbritannien; de mulige værdier for Health State Index-scoren varierede fra -0,59 (alvorlige problemer i alle 5 dimensioner) til 1,0 (intet problem i nogen dimension). Den anden del af EQ-5D var en VAS, der gjorde det muligt for deltagerne at vurdere deres nuværende helbredstilstand. Mulige EQ-5D VAS-scorer varierede fra 0 (værst tænkelige sundhedstilstand) til 100 (bedst tænkelige sundhedstilstand).
Baseline, 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
Maksimale og minimale serumkoncentrationer (Cmax og Cmin) af Ramucirumab
Tidsramme: Før infusion og 1 time efter infusion i 4 og 8 (cyklus 3 og 5 ved 21 dage/cyklus)
Før infusion og 1 time efter infusion i 4 og 8 (cyklus 3 og 5 ved 21 dage/cyklus)
Antal deltagere med anti-ramucirumab antistoffer
Tidsramme: Baseline, før infusion i uge 4 og 8 (cyklus 3 og 5) og 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
Antallet af deltagere, der havde behandlings-emergent eller follow-up emergent anti-drug antistoffer (ADA) er rapporteret. Deltagere med behandlings-emergent ADA blev defineret som deltagere, der havde en hvilken som helst prøve fra baseline gennem cyklus 5 præ-infusion, der var en 4-fold stigning (2 fortyndingsstigning) i immunogenicitetstiter over baseline-titeren, eller deltagere, der testede negativ ved baseline og positiv post-baseline (ved titer på ≥1:20). Deltagere med opfølgende opstået ADA blev defineret som deltagere, der havde en prøve i løbet af 30 dage efter sidste infusion, som var en 4-fold stigning (2 fortyndingsstigning) i immunogenicitetstiter i forhold til basislinjetiteren.
Baseline, før infusion i uge 4 og 8 (cyklus 3 og 5) og 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere, der havde behandlingsfremkaldte bivirkninger (TEAE'er) eller døde
Tidsramme: Første infusion op til 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)
De præsenterede data er antallet af deltagere, der oplevede mindst 1 TEAE, grad 3, 4 eller 5 TEAE, behandlingsudløst alvorlig bivirkning (SAE), TEAE, der førte til afbrydelse af undersøgelsesbehandlingen (ramucirumab/placebo eller docetaxel) og TEAE fører til døden. Klinisk signifikante hændelser blev defineret som behandlingsfremkaldte SAE'er og andre ikke-alvorlige bivirkninger (AE'er) uanset årsagssammenhæng. En oversigt over SAE'er og andre ikke-alvorlige AE'er, uanset årsagssammenhæng, findes i modulet Rapporterede bivirkninger.
Første infusion op til 30 dage efter sidste infusion (op til cyklus 38, 21 dage/cyklus)

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2010

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

16. juli 2010

Først indsendt, der opfyldte QC-kriterier

22. juli 2010

Først opslået (Skøn)

23. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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IPD-planbeskrivelse

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IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

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IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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Kliniske forsøg med Ikke-småcellet lungekræft

Kliniske forsøg med Ramucirumab

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