En studie av kjemoterapi og ramucirumab versus kjemoterapi alene i andre linje ikke-småcellet lungekreft (NSCLC)-deltakere som mottok tidligere førstelinjeplatinabasert kjemoterapi
10. september 2019 oppdatert av: Eli Lilly and Company
En randomisert, dobbeltblind fase 3-studie av docetaxel og ramucirumab versus docetaxel og placebo i behandling av stadium IV ikke-småcellet lungekreft etter sykdomsprogresjon etter én tidligere platinabasert terapi
Formålet med studien er å sammenligne overlevelsen til deltakere som får kjemoterapi og ramucirumab versus kjemoterapi alene som andrelinjebehandling for NSCLC etter tidligere førstelinjeplatinabasert kjemoterapi.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1253
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Brasil, 14784700
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Belo Horizonte, Brasil, 31110580
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Goiania, Brasil, 74140050
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Porto Alegre, Brasil, 90430-090
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São Paulo, Brasil, 1224010
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
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Quebec
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Sainte-Foy, Quebec, Canada, G1V 4G5
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Moscow, Den russiske føderasjonen, 115478
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Saint Petersburg, Den russiske føderasjonen, 197758
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Stavropol, Den russiske føderasjonen, 355047
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Arizona
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Phoenix, Arizona, Forente stater, 85016
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Sedona, Arizona, Forente stater, 86336
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Arkansas
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Fayetteville, Arkansas, Forente stater, 72703
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California
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Alhambra, California, Forente stater, 91801
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Duarte, California, Forente stater, 91010
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Fresno, California, Forente stater, 93720
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Fullerton, California, Forente stater, 92835
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La Jolla, California, Forente stater, 92093
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Long Beach, California, Forente stater, 90813
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Los Angeles, California, Forente stater, 90095
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Northridge, California, Forente stater, 91325
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Redondo Beach, California, Forente stater, 90277
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Santa Barbara, California, Forente stater, 93105
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Santa Monica, California, Forente stater, 93454
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Colorado
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Denver, Colorado, Forente stater, 80218
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Connecticut
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Waterbury, Connecticut, Forente stater, 06708
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Florida
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Jacksonville, Florida, Forente stater, 32204
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Miami, Florida, Forente stater, 33176
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Ocala, Florida, Forente stater, 34471
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Orlando, Florida, Forente stater, 32806
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Georgia
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Athens, Georgia, Forente stater, 30607
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Augusta, Georgia, Forente stater, 30901
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Lawrenceville, Georgia, Forente stater, 30045
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Macon, Georgia, Forente stater, 31201
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Rome, Georgia, Forente stater, 30165
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Savannah, Georgia, Forente stater, 31405
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Illinois
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Springfield, Illinois, Forente stater, 62703
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Indiana
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Bloomington, Indiana, Forente stater, 47402
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Iowa
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Cedar Rapids, Iowa, Forente stater, 52402
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Iowa City, Iowa, Forente stater, 52242
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Kansas
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Overland Park, Kansas, Forente stater, 66210
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Wichita, Kansas, Forente stater, 67214
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Kentucky
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Ashland, Kentucky, Forente stater, 41101
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Mount Sterling, Kentucky, Forente stater, 40353
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
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Metairie, Louisiana, Forente stater, 70006
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Maryland
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Bethesda, Maryland, Forente stater, 20817
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Chevy Chase, Maryland, Forente stater, 20815
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
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Danvers, Massachusetts, Forente stater, 01923
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Framingham, Massachusetts, Forente stater, 01701
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Newton, Massachusetts, Forente stater, 02462
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
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Missouri
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Columbia, Missouri, Forente stater, 65201
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Joplin, Missouri, Forente stater, 64804
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Saint Louis, Missouri, Forente stater, 63110
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Montana
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Billings, Montana, Forente stater, 59101
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Nevada
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Henderson, Nevada, Forente stater, 89169
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Reno, Nevada, Forente stater, 89502
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
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Portsmouth, New Hampshire, Forente stater, 03801
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
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New York
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Bronx, New York, Forente stater, 10467
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Latham, New York, Forente stater, 12110
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New York, New York, Forente stater, 10021
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North Carolina
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Durham, North Carolina, Forente stater, 27704
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Raleigh, North Carolina, Forente stater, 27607
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North Dakota
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Fargo, North Dakota, Forente stater, 58122
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Ohio
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Columbus, Ohio, Forente stater, 43219
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74136
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19001
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Kingston, Pennsylvania, Forente 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.
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Philadelphia, Pennsylvania, Forente 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.
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South Carolina
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Charleston, South Carolina, Forente stater, 29414
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57104
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Tennessee
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Chattanooga, Tennessee, Forente 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.
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Memphis, Tennessee, Forente 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.
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Texas
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Abilene, Texas, Forente 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.
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Amarillo, Texas, Forente 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.
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Beaumont, Texas, Forente 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.
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Bedford, Texas, Forente 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.
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Dallas, Texas, Forente 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.
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El Paso, Texas, Forente 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.
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Fort Worth, Texas, Forente 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.
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Lewisville, Texas, Forente 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.
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McAllen, Texas, Forente 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.
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Mesquite, Texas, Forente 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.
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Midland, Texas, Forente 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.
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Odessa, Texas, Forente 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.
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Paris, Texas, Forente 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.
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San Antonio, Texas, Forente 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.
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San Antonio, Texas, Forente 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.
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Sherman, Texas, Forente 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.
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Sugar Land, Texas, Forente 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.
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The Woodlands, Texas, Forente 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.
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Tyler, Texas, Forente 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.
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Webster, Texas, Forente 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.
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Wichita Falls, Texas, Forente 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.
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Virginia
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Christiansburg, Virginia, Forente 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.
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Fairfax, Virginia, Forente 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.
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Newport News, Virginia, Forente 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.
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Richmond, Virginia, Forente 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.
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Washington
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Lacey, Washington, Forente 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.
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Spokane, Washington, Forente 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.
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Wenatchee, Washington, Forente 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.
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Wisconsin
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Madison, Wisconsin, Forente 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.
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Grenoble, Frankrike, 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.
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Lille, Frankrike, 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.
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Lyon, Frankrike, 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.
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Nice, Frankrike, 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.
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Strasbourg, Frankrike, 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.
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Toulouse, Frankrike, 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.
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Vandoeuvre Les Nancy, Frankrike, 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.
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Athens, Hellas, 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.
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Chania, Hellas, 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.
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Kifissia, Hellas, 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.
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Patras, Hellas, 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.
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Bangalore, India, 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.
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Cuttack, India, 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.
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Delhi, India, 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.
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Jaipur, India, 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.
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Kochin, India, 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.
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Madurai, India, 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.
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Mumbai, India, 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.
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Pune, India, 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.
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Trivandrum, India, 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.
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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.
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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.
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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.
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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.
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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.
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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.
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Livorno, Italia, 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.
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Monza, Italia, 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.
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Novara, Italia, 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.
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Padova, Italia, 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.
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Palermo, Italia, 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.
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Parma, Italia, 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.
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Pisa, Italia, 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.
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Rome, Italia, 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.
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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.
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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.
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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.
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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.
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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.
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Amsterdam, Nederland, 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.
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Arnhem, Nederland, 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.
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Harderwijk, Nederland, 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.
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S-Hertogenbosch, Nederland, 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.
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Zwolle, Nederland, 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Bayamon, Puerto Rico, 00959
- 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.
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Bucharest, Romania, 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.
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Cluj-Napoca, Romania, 400058
- 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.
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Iasi, Romania, 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.
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Barcelona, Spania, 08003
- 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.
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Girona, Spania, 17007
- 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.
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Las Palmas De Gran Canaria, Spania, 35016
- 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.
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Madrid, Spania, 28050
- 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.
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Mataró, Spania, 08304
- 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.
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Pamplona, Spania, 31008
- 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.
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Pozuelo De Alarcon, Spania, 28223
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East Yorkshire
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Cottingham, East Yorkshire, Storbritannia, HU16 5JQ
- 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.
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Greater London
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London, Greater London, Storbritannia, W6 8RF
- 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.
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Lancashire
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Preston, Lancashire, Storbritannia, PR2 9HT
- 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.
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Manchester
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Wythenshawe, Manchester, Storbritannia, M23 9LT
- 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.
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Storbritannia, DN15 7BH
- 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.
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Scotland
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Glasgow, Scotland, Storbritannia, G12 0YN
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West Midlands
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Coventry, West Midlands, Storbritannia, CV2 2DX
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Wolverhampton, West Midlands, Storbritannia, WV10 0QP
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Basel, Sveits, CH-4031
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Bern, Sveits, CH-3010
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Fribourg, Sveits, 1708
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Luzern, Sveits, CH-6000
- 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.
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Zurich, Sveits, CH-8091
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Eskilstuna, Sverige, 63188
- 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.
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Linkoping, Sverige, 58185
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Lund, Sverige, 22185
- 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.
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Solna, Sverige, 17176
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Kaohsiung, Taiwan, 813
- 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.
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Kuei Shan Hsiang, Taiwan, 33305
- 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.
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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.
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 11031
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Ankara, Tyrkia, 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.
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Istanbul, Tyrkia, 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.
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Izmir, Tyrkia, 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.
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Kayseri, Tyrkia, 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.
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Augsburg, Tyskland, 86150
- 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.
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Bad Soden, Tyskland, 65812
- 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.
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Bielefeld, Tyskland, 33611
- 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.
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Dresden, Tyskland, 01307
- 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.
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Frankfurt, Tyskland, 60596
- 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.
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Gerlingen, Tyskland, 70839
- 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.
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Großhansdorf, Tyskland, 22927
- 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.
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Halle, Tyskland, 06120
- 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.
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Heidelberg, Tyskland, 69126
- 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.
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Immenhausen, Tyskland, 34376
- 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.
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Oldenburg, Tyskland, 26121
- 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.
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Ulm, Tyskland, 89081
- 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.
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Villingen-Schwenningen, Tyskland, 78050
- 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.
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Budapest, Ungarn, 1145
- 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.
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Gyula, Ungarn, 5703
- 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.
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Matrahaza, Ungarn, 3233
- 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.
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Nyiregyhaza, Ungarn, 4412
- 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.
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Pécs, Ungarn, 7623
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Szekesfehervar, Ungarn, 8000
- 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.
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Graz, Østerrike, 8036
- 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.
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Grimmenstein, Østerrike, 2840
- 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.
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Vienna, Østerrike, A-1140
- 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.
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Wels, Østerrike, 4600
- 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.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Sykdomsprogresjon under eller etter én tidligere førstelinjeplatinabasert kjemoterapi med eller uten vedlikeholdsbehandling
- Tidligere bevacizumab som førstelinje- og/eller vedlikeholdsbehandling er tillatt
- Signert informert samtykke
- Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0-1
- Histologisk eller cytologisk bekreftet NSCLC
- Stage IV NSCLC sykdom
- Deltakerne har målbar eller ikke-målbar sykdom
Tilstrekkelig organfunksjon, definert som:
- Totalt bilirubin mindre enn eller lik øvre normalgrense (ULN),
- Aspartataminotransferase (AST) og alaninaminotransaminase (ALT) mindre enn eller lik 2,5 x ULN, eller mindre enn eller lik 5 x ULN hvis transferaseøkningen skyldes levermetastaser,
- Serumkreatinin mindre enn eller lik 1,5 x ULN eller beregnet kreatininclearance større enn eller lik 50 milliliter per minutt (ml/min) (i henhold til Cockcroft-Gault-formelen eller tilsvarende og/eller 24-timers urinsamling),
- Absolutt nøytrofiltall (ANC) større enn eller lik 1,5 x 10^3/mikroliter (µL), hemoglobin større enn eller lik 10,0 gram/desiliter (g/dL), og blodplater større enn eller lik 100 x 10^3 /µL,
- Tilstrekkelig koagulasjonsfunksjon som definert av International Normalized Ratio (INR) mindre enn eller lik 1,5, eller protrombintid og partiell tromboplastintid mindre enn eller lik 1,5 x ULN.
- Deltakeren har ikke cirrhose på et nivå av Child-Pugh B (eller verre) eller cirrhose (noen grad) og en historie med hepatisk encefalopati eller klinisk meningsfull ascites som følge av cirrhose. Klinisk meningsfull ascites er definert som ascites som skyldes skrumplever og som krever pågående behandling med diuretika og/eller paracentese.
- Urinprotein er mindre enn eller lik 1+ på peilepinne eller rutinemessig urinanalyse. Hvis urinpeilepinne eller rutineanalyse indikerer proteinuri større enn eller lik 2+, må en 24-timers urin samles og må vise mindre enn 1000 milligram (mg) protein.
- Deltakere med reproduksjonspotensial (begge kjønn) må godta å bruke pålitelig prevensjonsmetode (hormonelle eller barrieremetoder) i løpet av studieperioden og minst 12 uker etter siste dose av studieterapien
- Forventet levealder større enn eller lik 3 måneder
- Forutgående strålebehandling er tillatt dersom: Ved strålebehandling av thorax har det gått minst 28 dager fra fullført strålebehandling før randomisering; Ved fokal eller palliativ strålebehandling har det gått minst 7 dager fra siste strålebehandling før randomisering (og forutsatt at 25 % eller mindre av total benmarg hadde blitt bestrålt); Ved stråling fra sentralnervesystemet (CNS) har det gått minst 14 dager fra fullført strålebehandling før randomisering
Ekskluderingskriterier:
- Sykdomsprogresjon på mer enn 1 tidligere kjemoterapiregimer
- Deltakere hvis eneste tidligere behandling var en tyrosinkinasehemmer
- Deltakerens svulst inneholder helt eller delvis småcellet lungekreft
- Større operasjon innen 28 dager før randomisering, eller plassering av subkutan venøs tilgangsenhet innen 7 dager før randomisering. Postoperative blødningskomplikasjoner eller sårkomplikasjoner fra et kirurgisk inngrep utført de siste 2 månedene.
- Samtidig behandling med annen kreftbehandling, inkludert annen kjemoterapi, immunterapi, hormonbehandling, kjemoembolisering eller målrettet terapi
- Siste dose bevacizumab må være minst 28 dager fra tidspunktet for randomisering
- Siste dose cytotoksisk kjemoterapi må være minst 14 dager fra tidspunktet for randomisering
- Deltakeren har ubehandlede CNS-metastaser. Deltakere med behandlede hjernemetastaser er kvalifisert hvis de er klinisk stabile med hensyn til nevrologisk funksjon, av steroider etter kranial bestråling som avsluttes minst 2 uker før randomisering, eller etter kirurgisk reseksjon utført minst 28 dager før randomisering. Ingen tegn på grad større enn eller lik 1 CNS-blødning basert på magnetisk resonansavbildning (MRI) eller IV-kontrastdatatomografi (CT)-skanning før behandling.
- Radiologisk dokumentert bevis på større blodkarinvasjon eller omslutning av kreft
- Radiografisk bevis på intratumorkavitasjon
- Anamnese med ukontrollert arvelig eller ervervet trombotisk lidelse
- Kronisk terapi med ikke-steroide antiinflammatoriske legemidler (NSAIDs) eller andre blodplatehemmende midler; Aspirinbruk i doser opptil 325 milligram per dag (mg/dag) er tillatt
- Anamnese med grov hemoptyse (definert som knallrødt blod eller større enn eller lik 1/2 teskje) innen 2 måneder før randomisering
- Klinisk relevant kongestiv hjertesvikt [New York Heart Association (NYHA II-IV)] eller symptomatisk eller dårlig kontrollert hjertearytmi
- Enhver arteriell trombotisk hendelse, inkludert hjerteinfarkt, ustabil angina, cerebrovaskulær ulykke eller forbigående iskemisk angrep, innen 6 måneder før randomisering
- Ukontrollert arteriell hypertensjon større enn eller lik 150 / større enn eller lik 90 millimeter kvikksølv (mm Hg) til tross for standard medisinsk behandling
- Alvorlig eller ikke-helende sår, sår eller benbrudd innen 28 dager før randomisering
- Betydelige blødningsforstyrrelser, vaskulitt eller grad 3/4 gastrointestinal blødning innen 3 måneder før randomisering
- Gastrointestinal (GI) perforering og/eller fistler innen 6 måneder før randomisering
- Tarmobstruksjon, historie eller tilstedeværelse av inflammatorisk enteropati eller omfattende tarmreseksjon Crohns sykdom, ulcerøs kolitt eller kronisk diaré
- Perifer nevropati større enn eller lik grad 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) versjon 4.02]
- Alvorlig sykdom eller medisinsk(e) tilstand(er), inkludert, men ikke begrenset til: Humant immunsviktvirus (HIV)-infeksjon eller ervervet immunsviktsyndrom (AIDS)-relatert sykdom; Aktiv eller ukontrollert klinisk alvorlig infeksjon; Alvorlig akutt eller kronisk medisinsk eller psykiatrisk tilstand eller laboratorieavvik som kan øke risikoen forbundet med studiedeltakelse eller administrering av studiemedisin
- Kjent allergi- eller overfølsomhetsreaksjon mot noen av behandlingskomponentene
- Deltakeren er gravid eller ammer
- Nåværende eller nylig (innen 28 dager før randomisering) behandling med et undersøkelseslegemiddel eller utstyr som ikke har mottatt myndighetsgodkjenning for noen indikasjon på tidspunktet for randomisering, eller deltakelse i en annen intervensjonell klinisk studie
- Tidligere behandling med docetaksel
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Ramucirumab + Docetaxel
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10 milligram per kilogram (mg/kg) administrert intravenøst (IV) på dag 1 av 21-dagers syklus inntil sykdomsprogresjon, uakseptabel toksisitet eller et annet abstinenskriterium er oppfylt
Andre navn:
75 milligram per kvadratmeter (mg/m^2) (60 mg/m^2 for landene Korea og Taiwan bare med protokollendringer datert 22. mai 2012) administrert IV på dag 1 av 21-dagers syklus inntil sykdomsprogresjon, uakseptabelt toksisitet, eller et annet tilbaketrekningskriterium er oppfylt
|
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Placebo komparator: Placebo + Docetaxel
|
75 milligram per kvadratmeter (mg/m^2) (60 mg/m^2 for landene Korea og Taiwan bare med protokollendringer datert 22. mai 2012) administrert IV på dag 1 av 21-dagers syklus inntil sykdomsprogresjon, uakseptabelt toksisitet, eller et annet tilbaketrekningskriterium er oppfylt
Administrert IV på dag 1 av 21-dagers syklus inntil sykdomsprogresjon, uakseptabel toksisitet eller et annet seponeringskriterium er oppfylt
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total overlevelse
Tidsramme: Randomisering til dødsdato uansett årsak (opptil 34 måneder)
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Total overlevelse var tiden fra randomisering til dødsdato uansett årsak.
Deltakere som var i live ved slutten av oppfølgingsperioden (eller tapte for oppfølging) ble sensurert på den siste datoen deltakeren var kjent for å være i live.
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Randomisering til dødsdato uansett årsak (opptil 34 måneder)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Progresjonsfri overlevelsestid (PFS).
Tidsramme: Randomisering til målt PD eller dødsdato uansett årsak (opptil 29 måneder)
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PFS-tid var tiden fra randomisering til datoen for objektivt bestemt progressiv sykdom (PD) eller død på grunn av en hvilken som helst årsak, avhengig av hva som inntraff først.
I henhold til Response Evaluation Criteria in Solid Tumors versjon 1.1 (RECIST v1.1), var PD en økning på minst 20 % i summen av diametrene til mållesjonene, med den minste summen i studien som referanse.
I tillegg til 20 % relativ økning, må summen også ha vist en absolutt økning på minst 5 millimeter (mm).
Forekomsten av 1 eller flere nye lesjoner og/eller utvetydig progresjon av eksisterende ikke-mållesjoner ble også ansett som progresjon.
Deltakere uten objektivt bestemt PD som var i live ved slutten av oppfølgingsperioden (eller tapte for oppfølging) ble sensurert på datoen for deltakerens siste fullstendige radiografiske tumorvurdering; hvis ingen baseline eller post-baseline radiologisk vurdering var tilgjengelig, ble deltakeren sensurert ved randomiseringsdatoen.
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Randomisering til målt PD eller dødsdato uansett årsak (opptil 29 måneder)
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Prosentandel av deltakere som oppnår en objektiv respons (Objective Response Rate)
Tidsramme: Grunnlinje til målt PD (opptil 29 måneder)
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Deltakerne oppnådde en objektiv respons hvis de hadde en best samlet respons av delvis respons (PR) eller komplett respons (CR).
I henhold til RECIST v1.1 ble PR definert som en reduksjon på minst 30 % i summen av diametrene til mållesjoner (inkludert de korte aksene til en hvilken som helst mållymfeknute), med basislinjesumdiameteren som referanse; CR var forsvinningen av alle ikke-nodale mållesjoner, med de korte aksene til enhver mållymfeknute redusert til <10 mm, forsvinningen av alle ikke-mållesjoner og normalisering av tumormarkørnivåer [hvis tumormarkører opprinnelig var over de øvre normalgrense (ULN)].
Prosentandelen av deltakere som oppnådde en objektiv respons=(antall deltakere med CR eller PR)/(antall deltakere vurdert)*100.
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Grunnlinje til målt PD (opptil 29 måneder)
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Prosentandel av deltakere som oppnår sykdomskontroll (sykdomskontrollfrekvens)
Tidsramme: Grunnlinje til målt PD (opptil 29 måneder)
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Deltakerne oppnådde sykdomskontroll hvis de hadde den beste generelle responsen på PR, CR eller stabil sykdom (SD).
I henhold til RECIST v1.1 ble PR definert som en reduksjon på minst 30 % i summen av diametrene til mållesjoner (inkludert de korte aksene til en hvilken som helst mållymfeknute), med basislinjesumdiameteren som referanse; CR var forsvinningen av alle ikke-nodale mållesjoner, med de korte aksene til enhver mållymfeknute redusert til <10 mm, forsvinningen av alle ikke-mållesjoner og normaliseringen av tumormarkørnivåer (hvis tumormarkører opprinnelig var over ULN) ).
SD var verken tilstrekkelig krymping til å kvalifisere som PR eller tilstrekkelig økning til å kvalifisere som PD, med den minste sumdiameteren siden behandlingen startet som referanse.
Prosentandelen av deltakere som oppnådde sykdomskontroll=(antall deltakere med CR, PR eller SD)/(antall deltakere vurdert)*100.
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Grunnlinje til målt PD (opptil 29 måneder)
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Maksimal forbedring på Lung Cancer Symptom Scale (LCSS)
Tidsramme: Baseline, dag 21 i hver syklus og 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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LCSS besto av 9 punkter: 6 punkter fokusert på lungekreftsymptomer [tap av appetitt, tretthet, hoste, dyspné (pustebesvær), hemoptyse (blod i oppspytt) og smerter] og 3 punkter var globale punkter (symptombesvær, forstyrrelse av aktivitetsnivå og global livskvalitet).
Deltakerresponser på hvert element ble målt ved hjelp av visuelle analoge skalaer (VAS) med 100 mm linjer.
En høyere poengsum for ethvert element representerte et høyere nivå av symptomer/problemer.
Average Symptom Burden Index (ASBI) var gjennomsnittet av de 6 symptomelementene i LCSS, og Total LCSS var gjennomsnittet av alle 9 LCSS-elementene.
ASBI og Total LCSS ble ikke beregnet for en deltaker hvis han/hun hadde 1 eller flere manglende verdier for henholdsvis 6 og 9 elementer.
Maksimal forbedring i LCSS-score, ASBI og Total LCSS-score var den største nedgangen fra baseline for hver variabel, som var den minste (mest negative eller minste positive) ikke-manglende verdien blant alle endringer fra baseline-verdier for hver variabel.
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Baseline, dag 21 i hver syklus og 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Endring fra baseline til 30-dagers oppfølgingsbesøk på European Quality of Life Questionnaire-5 Dimension (EQ-5D) Helseresultater
Tidsramme: Baseline, 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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EQ-5D er et livskvalitetsinstrument som består av 2 deler.
Den første delen (Health State Index-score) tillot deltakerne å rangere helsetilstanden sin i 5 helsedomener: mobilitet, egenomsorg, vanlige aktiviteter, smerte/ubehag og angst/depresjon ved å bruke en skala fra 1 til 3 (ingen problem, noen henholdsvis problemer og ekstreme problemer).
Disse kombinasjonene av attributter ble konvertert til en vektet helsetilstandsindeks i henhold til en populasjonsbasert algoritme i Storbritannia; de mulige verdiene for helsetilstandsindeksen varierte fra -0,59 (alvorlige problemer i alle 5 dimensjoner) til 1,0 (ingen problem i noen dimensjon).
Den andre delen av EQ-5D var en VAS som tillot deltakerne å vurdere sin nåværende helsetilstand.
Mulige EQ-5D VAS-skårer varierte fra 0 (dårligst tenkelige helsetilstand) til 100 (best tenkelige helsetilstand).
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Baseline, 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Maksimal og minimum serumkonsentrasjon (Cmax og Cmin) av Ramucirumab
Tidsramme: Før infusjon og 1 time etter infusjon i 4 og 8 (syklus 3 og 5 ved 21 dager/syklus)
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Før infusjon og 1 time etter infusjon i 4 og 8 (syklus 3 og 5 ved 21 dager/syklus)
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Antall deltakere med anti-ramucirumab antistoffer
Tidsramme: Grunnlinje, før infusjon i uke 4 og 8 (syklus 3 og 5), og 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Antall deltakere som hadde behandlings-emergent eller follow-up emergent anti-drug antistoffer (ADA) er rapportert.
Deltakere med behandlingsfremkommet ADA ble definert som deltakere som hadde en prøve fra baseline gjennom syklus 5 pre-infusjon som var en 4 ganger økning (2 fortynningsøkning) i immunogenisitetstiter over baseline titer, eller deltakere som testet negativt ved baseline og positiv post-baseline (ved titer på ≥1:20).
Deltakere med oppfølging av ADA ble definert som deltakere som hadde en prøve i løpet av 30 dager etter siste infusjon som var en 4 ganger økning (2 fortynningsøkning) i immunogenisitetstiter over baselinetiter.
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Grunnlinje, før infusjon i uke 4 og 8 (syklus 3 og 5), og 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Antall deltakere som hadde behandlingsoppståtte bivirkninger (TEAE) eller døde
Tidsramme: Første infusjon opptil 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Data presentert er antall deltakere som opplevde minst 1 TEAE, grad 3, 4 eller 5 TEAE, behandlingsfremkommet alvorlig bivirkning (SAE), TEAE som førte til seponering av studiebehandlingen (ramucirumab/placebo eller docetaxel) og TEAE fører til døden.
Klinisk signifikante hendelser ble definert som behandlingsfremkomne SAE og andre ikke-alvorlige bivirkninger (AE) uavhengig av årsakssammenheng.
Et sammendrag av SAE-er og andre ikke-alvorlige AE-er, uavhengig av årsakssammenheng, finnes i modulen Rapporterte uønskede hendelser.
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Første infusjon opptil 30 dager etter siste infusjon (opp til syklus 38, 21 dager/syklus)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.
- Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567.
- Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.
- Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2010
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
16. juli 2010
Først innsendt som oppfylte QC-kriteriene
22. juli 2010
Først lagt ut (Anslag)
23. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Docetaxel
- Ramucirumab
- Antistoffer, monoklonale
Andre studie-ID-numre
- 13852
- I4T-MC-JVBA (Annen identifikator: Eli Lilly and Company)
- 2010-021297-11 (EudraCT-nummer)
- CP12-1027 (Annen identifikator: ImClone Trial Number)
- CTRI/2011/08/001942 (Registeridentifikator: Clinical Trials Registry India)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.
IPD-delingstidsramme
Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere.
Data vil være tilgjengelig på ubestemt tid for forespørsel.
Tilgangskriterier for IPD-deling
Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .