Un estudio de quimioterapia y ramucirumab versus quimioterapia sola en participantes con cáncer de pulmón de células no pequeñas (NSCLC, por sus siglas en inglés) de segunda línea que recibieron quimioterapia previa a base de platino de primera línea
10 de septiembre de 2019 actualizado por: Eli Lilly and Company
Un estudio aleatorizado, doble ciego, de fase 3 de docetaxel y ramucirumab versus docetaxel y placebo en el tratamiento del cáncer de pulmón de células no pequeñas en estadio IV después de la progresión de la enfermedad después de una terapia previa con platino
El propósito del estudio es comparar la supervivencia de los participantes que reciben quimioterapia y ramucirumab versus quimioterapia sola como tratamiento de segunda línea para NSCLC después de quimioterapia previa de primera línea basada en platino.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1253
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Augsburg, Alemania, 86150
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Bad Soden, Alemania, 65812
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Bielefeld, Alemania, 33611
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Dresden, Alemania, 01307
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Frankfurt, Alemania, 60596
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Gerlingen, Alemania, 70839
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Großhansdorf, Alemania, 22927
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Halle, Alemania, 06120
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Heidelberg, Alemania, 69126
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Immenhausen, Alemania, 34376
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Oldenburg, Alemania, 26121
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Ulm, Alemania, 89081
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Villingen-Schwenningen, Alemania, 78050
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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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Graz, Austria, 8036
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Grimmenstein, Austria, 2840
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Vienna, Austria, A-1140
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Wels, Austria, 4600
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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, Canadá, T6G 1Z2
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New Brunswick
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Moncton, New Brunswick, Canadá, E1C 6Z8
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Quebec
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Sainte-Foy, Quebec, Canadá, G1V 4G5
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Incheon, Corea, república de, 405-760
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Seoul, Corea, república de, 120-752
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Suwon-City, Corea, república de, 442-723
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Barcelona, España, 08003
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Girona, España, 17007
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Las Palmas De Gran Canaria, España, 35016
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Madrid, España, 28050
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Mataró, España, 08304
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Pamplona, España, 31008
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Pozuelo De Alarcon, España, 28223
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
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Sedona, Arizona, Estados Unidos, 86336
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
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California
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Alhambra, California, Estados Unidos, 91801
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Duarte, California, Estados Unidos, 91010
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Fresno, California, Estados Unidos, 93720
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Fullerton, California, Estados Unidos, 92835
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La Jolla, California, Estados Unidos, 92093
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Long Beach, California, Estados Unidos, 90813
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Los Angeles, California, Estados Unidos, 90095
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Northridge, California, Estados Unidos, 91325
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Redondo Beach, California, Estados Unidos, 90277
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Santa Barbara, California, Estados Unidos, 93105
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Santa Monica, California, Estados Unidos, 93454
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Colorado
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Denver, Colorado, Estados Unidos, 80218
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Connecticut
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Waterbury, Connecticut, Estados Unidos, 06708
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Florida
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Jacksonville, Florida, Estados Unidos, 32204
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Miami, Florida, Estados Unidos, 33176
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Ocala, Florida, Estados Unidos, 34471
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Orlando, Florida, Estados Unidos, 32806
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Georgia
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Athens, Georgia, Estados Unidos, 30607
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Augusta, Georgia, Estados Unidos, 30901
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Lawrenceville, Georgia, Estados Unidos, 30045
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Macon, Georgia, Estados Unidos, 31201
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Rome, Georgia, Estados Unidos, 30165
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Savannah, Georgia, Estados Unidos, 31405
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Illinois
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Springfield, Illinois, Estados Unidos, 62703
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Indiana
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Bloomington, Indiana, Estados Unidos, 47402
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52402
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Iowa City, Iowa, Estados Unidos, 52242
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210
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Wichita, Kansas, Estados Unidos, 67214
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Kentucky
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Ashland, Kentucky, Estados Unidos, 41101
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Mount Sterling, Kentucky, Estados Unidos, 40353
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
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Metairie, Louisiana, Estados Unidos, 70006
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
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Chevy Chase, Maryland, Estados Unidos, 20815
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
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Danvers, Massachusetts, Estados Unidos, 01923
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Framingham, Massachusetts, Estados Unidos, 01701
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Newton, Massachusetts, Estados Unidos, 02462
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
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Joplin, Missouri, Estados Unidos, 64804
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Saint Louis, Missouri, Estados Unidos, 63110
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Montana
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Billings, Montana, Estados Unidos, 59101
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Nevada
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Henderson, Nevada, Estados Unidos, 89169
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Reno, Nevada, Estados Unidos, 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.
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Portsmouth, New Hampshire, Estados Unidos, 03801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 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.
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New York
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Bronx, New York, Estados Unidos, 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.
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Latham, New York, Estados Unidos, 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.
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New York, New York, Estados Unidos, 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.
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North Carolina
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Durham, North Carolina, Estados Unidos, 27704
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Raleigh, North Carolina, Estados Unidos, 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.
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Ohio
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Columbus, Ohio, Estados Unidos, 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.
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 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.
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 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.
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Kingston, Pennsylvania, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 29414
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57104
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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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Moscow, Federación Rusa, 115478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Saint Petersburg, Federación Rusa, 197758
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Stavropol, Federación Rusa, 355047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Francia, 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, Francia, 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, Francia, 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, Francia, 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, Francia, 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, Francia, 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, Francia, 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, Grecia, 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, Grecia, 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, Grecia, 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, Grecia, 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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Budapest, Hungría, 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, Hungría, 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, Hungría, 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, Hungría, 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, Hungría, 7623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Szekesfehervar, Hungría, 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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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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Guadalajara, México, 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, México, 14000
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Oslo, Noruega, 0310
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Tromsø, Noruega, 9012
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Grafton, Nueva Zelanda, 1023
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Wellington, Nueva Zelanda, 6002
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Ankara, Pavo, 06500
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Istanbul, Pavo, 81540
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Izmir, Pavo, 35340
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Kayseri, Pavo, 38039
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Amsterdam, Países Bajos, 1091AC
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Arnhem, Países Bajos, 6815 AD
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Harderwijk, Países Bajos, 3844 DG
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S-Hertogenbosch, Países Bajos, 5223 GZ
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Zwolle, Países Bajos, 80211 JW
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Gdansk, Polonia, 80-219
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Gdynia, Polonia, 81-519
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Glucholazy, Polonia, 48-340
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Krakow, Polonia, 31-202
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Lodz, Polonia, 90-242
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Opole, Polonia, 45-060
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Otwock, Polonia, 05-400
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Poznan, Polonia, 60-693
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Bayamon, Puerto Rico, 00959
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East Yorkshire
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Cottingham, East Yorkshire, Reino Unido, HU16 5JQ
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Greater London
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London, Greater London, Reino Unido, W6 8RF
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Lancashire
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Preston, Lancashire, Reino Unido, PR2 9HT
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Manchester
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Wythenshawe, Manchester, Reino Unido, M23 9LT
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Reino Unido, DN15 7BH
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Scotland
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Glasgow, Scotland, Reino Unido, G12 0YN
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West Midlands
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Coventry, West Midlands, Reino Unido, CV2 2DX
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Wolverhampton, West Midlands, Reino Unido, WV10 0QP
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Bucharest, Rumania, 022328
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Cluj-Napoca, Rumania, 400058
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Iasi, Rumania, 700106
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Eskilstuna, Suecia, 63188
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Linkoping, Suecia, 58185
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Lund, Suecia, 22185
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Solna, Suecia, 17176
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Basel, Suiza, CH-4031
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Bern, Suiza, CH-3010
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Fribourg, Suiza, 1708
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Luzern, Suiza, CH-6000
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Zurich, Suiza, CH-8091
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Kaohsiung, Taiwán, 813
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Kuei Shan Hsiang, Taiwán, 33305
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Neihu Taipei, Taiwán, 114
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Niao Sung Hsiang, Taiwán, 833
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Taichung, Taiwán, 40705
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Taipei, Taiwán, 11031
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Criterios de inclusión:
- Progresión de la enfermedad durante o después de una quimioterapia previa basada en platino de primera línea con o sin terapia de mantenimiento
- Se permite bevacizumab previo como terapia de primera línea y/o de mantenimiento
- Consentimiento informado firmado
- Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0-1
- NSCLC confirmado histológica o citológicamente
- Enfermedad por CPCNP en estadio IV
- Los participantes tienen enfermedad medible o no medible
Función adecuada del órgano, definida como:
- Bilirrubina total inferior o igual al límite superior de la normalidad (LSN),
- Aspartato aminotransferasa (AST) y alanina aminotransaminasa (ALT) inferior o igual a 2,5 x ULN, o inferior o igual a 5 x ULN si la elevación de la transferasa se debe a metástasis hepáticas,
- Creatinina sérica inferior o igual a 1,5 x LSN o aclaramiento de creatinina calculado superior o igual a 50 mililitros por minuto (ml/min) (según la fórmula de Cockcroft-Gault o equivalente y/o recolección de orina de 24 horas),
- Recuento absoluto de neutrófilos (ANC) superior o igual a 1,5 x 10^3/microlitros (µL), hemoglobina superior o igual a 10,0 gramos/decilitro (g/dL) y plaquetas superior o igual a 100 x 10^3 /µL,
- Función de coagulación adecuada definida por el índice internacional normalizado (INR) inferior o igual a 1,5, o el tiempo de protrombina y el tiempo parcial de tromboplastina inferior o igual a 1,5 x LSN.
- El participante no tiene cirrosis a un nivel de Child-Pugh B (o peor) o cirrosis (cualquier grado) y antecedentes de encefalopatía hepática o ascitis clínicamente significativa como resultado de la cirrosis. La ascitis clínicamente significativa se define como la ascitis resultante de la cirrosis y que requiere un tratamiento continuo con diuréticos y/o paracentesis.
- La proteína urinaria es menor o igual a 1+ en la tira reactiva o en el análisis de orina de rutina. Si la tira reactiva de orina o el análisis de rutina indican proteinuria mayor o igual a 2+, se debe recolectar una orina de 24 horas y debe demostrar menos de 1000 miligramos (mg) de proteína.
- Los participantes con potencial reproductivo (ambos sexos) deben aceptar usar un método anticonceptivo confiable (métodos hormonales o de barrera) durante el período del estudio y al menos 12 semanas después de la última dosis de la terapia del estudio.
- Esperanza de vida mayor o igual a 3 meses
- Se permite la radioterapia previa si: En el caso de la radioterapia de tórax, han transcurrido al menos 28 días desde la finalización del tratamiento de radiación antes de la aleatorización; En el caso de tratamiento de radiación focal o paliativa, han transcurrido al menos 7 días desde el último tratamiento de radiación antes de la aleatorización (y siempre que se haya irradiado el 25 % o menos de la médula ósea total); En el caso de la radiación del Sistema Nervioso Central (SNC), han transcurrido al menos 14 días desde la finalización del tratamiento de radiación antes de la aleatorización.
Criterio de exclusión:
- Progresión de la enfermedad en más de 1 régimen de quimioterapia anterior
- Participantes cuyo único tratamiento previo fue un inhibidor de la tirosina quinasa
- El tumor del participante contiene total o parcialmente cáncer de pulmón de células pequeñas
- Cirugía mayor dentro de los 28 días previos a la aleatorización, o colocación de un dispositivo de acceso venoso subcutáneo dentro de los 7 días previos a la aleatorización. Complicaciones hemorrágicas postoperatorias o complicaciones de la herida de un procedimiento quirúrgico realizado en los últimos 2 meses.
- Tratamiento concurrente con otra terapia contra el cáncer, incluida otra quimioterapia, inmunoterapia, terapia hormonal, quimioembolización o terapia dirigida
- La última dosis de bevacizumab debe ser de al menos 28 días desde el momento de la aleatorización
- La última dosis de quimioterapia citotóxica debe ser de al menos 14 días desde el momento de la aleatorización
- El participante tiene metástasis del SNC no tratadas. Los participantes con metástasis cerebrales tratadas son elegibles si están clínicamente estables con respecto a la función neurológica, sin esteroides después de la irradiación craneal que finaliza al menos 2 semanas antes de la aleatorización o después de la resección quirúrgica realizada al menos 28 días antes de la aleatorización. No hay evidencia de hemorragia del SNC de grado mayor o igual a 1 según la resonancia magnética (RM) previa al tratamiento o la tomografía computarizada (TC) con contraste intravenoso.
- Evidencia radiológicamente documentada de invasión de vasos sanguíneos importantes o encapsulamiento por cáncer
- Evidencia radiográfica de cavitación intratumoral
- Antecedentes de trastorno trombótico hereditario o adquirido no controlado
- Terapia crónica con medicamentos antiinflamatorios no esteroideos (AINE) u otros agentes antiplaquetarios; Se permite el uso de aspirina en dosis de hasta 325 miligramos por día (mg/día)
- Antecedentes de hemoptisis macroscópica (definida como sangre de color rojo brillante o mayor o igual a 1/2 cucharadita) dentro de los 2 meses anteriores a la aleatorización
- Insuficiencia cardíaca congestiva clínicamente relevante [New York Heart Association (NYHA II-IV)] o arritmia cardíaca sintomática o mal controlada
- Cualquier evento trombótico arterial, incluido infarto de miocardio, angina inestable, accidente cerebrovascular o ataque isquémico transitorio, dentro de los 6 meses anteriores a la aleatorización
- Hipertensión arterial no controlada mayor o igual a 150 / mayor o igual a 90 milímetros de mercurio (mm Hg) a pesar del manejo médico estándar
- Herida, úlcera o fractura ósea grave o que no cicatriza en los 28 días anteriores a la aleatorización
- Trastornos hemorrágicos significativos, vasculitis o hemorragia gastrointestinal de grado 3/4 en los 3 meses anteriores a la aleatorización
- Perforación y/o fístula gastrointestinal (GI) en los 6 meses anteriores a la aleatorización
- Obstrucción intestinal, antecedentes o presencia de enteropatía inflamatoria o resección intestinal extensa Enfermedad de Crohn, colitis ulcerosa o diarrea crónica
- Neuropatía periférica mayor o igual a grado 2 [Criterios de terminología común para eventos adversos del Instituto Nacional del Cáncer (NCI-CTCAE) versión 4.02]
- Enfermedades o condiciones médicas graves que incluyen, entre otras: Infección por el virus de la inmunodeficiencia humana (VIH) o enfermedad relacionada con el síndrome de inmunodeficiencia adquirida (SIDA); Infección clínicamente grave activa o no controlada; Condición médica o psiquiátrica aguda o crónica grave o anormalidad de laboratorio que puede aumentar el riesgo asociado con la participación en el estudio o la administración del fármaco del estudio.
- Alergia conocida o reacción de hipersensibilidad a cualquiera de los componentes del tratamiento.
- La participante está embarazada o amamantando.
- Tratamiento actual o reciente (dentro de los 28 días previos a la aleatorización) con un fármaco o dispositivo en investigación que no ha recibido aprobación regulatoria para ninguna indicación en el momento de la aleatorización o participación en otro ensayo clínico de intervención
- Terapia previa con docetaxel
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ramucirumab + docetaxel
|
10 miligramos por kilogramo (mg/kg) administrados por vía intravenosa (IV) el día 1 del ciclo de 21 días hasta la progresión de la enfermedad, toxicidad inaceptable u otro criterio de abstinencia.
Otros nombres:
75 miligramos por metro cuadrado (mg/m^2) (60 mg/m^2 para los países de Corea y Taiwán solo con la modificación del protocolo del 22 de mayo de 2012) administrados por vía IV el día 1 del ciclo de 21 días hasta la progresión de la enfermedad, inaceptable toxicidad, o se cumple otro criterio de retiro
|
|
Comparador de placebos: Placebo + Docetaxel
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75 miligramos por metro cuadrado (mg/m^2) (60 mg/m^2 para los países de Corea y Taiwán solo con la modificación del protocolo del 22 de mayo de 2012) administrados por vía IV el día 1 del ciclo de 21 días hasta la progresión de la enfermedad, inaceptable toxicidad, o se cumple otro criterio de retiro
Administrado IV el día 1 del ciclo de 21 días hasta que se cumpla la progresión de la enfermedad, toxicidad inaceptable u otro criterio de retiro
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sobrevivencia promedio
Periodo de tiempo: Aleatorización hasta la fecha de muerte por cualquier causa (hasta 34 meses)
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La supervivencia global fue el tiempo desde la aleatorización hasta la fecha de muerte por cualquier causa.
Los participantes que estaban vivos al final del período de seguimiento (o perdidos durante el seguimiento) fueron censurados en la última fecha en que se supo que el participante estaba vivo.
|
Aleatorización hasta la fecha de muerte por cualquier causa (hasta 34 meses)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tiempo de supervivencia libre de progresión (PFS)
Periodo de tiempo: Aleatorización a DP medida o fecha de muerte por cualquier causa (hasta 29 meses)
|
El tiempo de SLP fue el tiempo desde la aleatorización hasta la fecha de enfermedad progresiva determinada objetivamente (EP) o muerte por cualquier causa, lo que ocurriera primero.
Según los Criterios de Evaluación de Respuesta en Tumores Sólidos versión 1.1 (RECIST v1.1), la PD fue al menos un 20% de aumento en la suma de los diámetros de las lesiones diana, tomando como referencia la suma más pequeña en estudio.
Además del aumento relativo del 20 %, la suma también debe haber demostrado un aumento absoluto de al menos 5 milímetros (mm).
También se consideró progresión la aparición de 1 o más lesiones nuevas y/o progresión inequívoca de lesiones no diana existentes.
Los participantes sin EP determinada objetivamente que estaban vivos al final del período de seguimiento (o perdidos durante el seguimiento) fueron censurados en la fecha de la última evaluación radiográfica completa del tumor del participante; si no se disponía de una evaluación radiológica inicial o posterior, se censuraba al participante en la fecha de la aleatorización.
|
Aleatorización a DP medida o fecha de muerte por cualquier causa (hasta 29 meses)
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Porcentaje de participantes que lograron una respuesta objetiva (tasa de respuesta objetiva)
Periodo de tiempo: Línea de base a la DP medida (hasta 29 meses)
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Los participantes lograron una respuesta objetiva si tenían una mejor respuesta general de respuesta parcial (PR) o respuesta completa (CR).
Según RECIST v1.1, la RP se definió como una disminución de al menos un 30 % en la suma de los diámetros de las lesiones diana (incluidos los ejes cortos de cualquier ganglio diana), tomando como referencia la suma del diámetro basal; RC fue la desaparición de todas las lesiones diana no ganglionares, con los ejes cortos de cualquier ganglio linfático diana reducido a <10 mm, la desaparición de todas las lesiones no diana y la normalización de los niveles de marcadores tumorales [si los marcadores tumorales estaban inicialmente por encima del límite superior límite de normalidad (ULN)].
El porcentaje de participantes que lograron una respuesta objetiva=(número de participantes con RC o PR)/(número de participantes evaluados)*100.
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Línea de base a la DP medida (hasta 29 meses)
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Porcentaje de participantes que lograron el control de la enfermedad (tasa de control de la enfermedad)
Periodo de tiempo: Línea de base a la DP medida (hasta 29 meses)
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Los participantes lograron el control de la enfermedad si tenían una mejor respuesta general de PR, RC o enfermedad estable (SD).
Según RECIST v1.1, la RP se definió como una disminución de al menos un 30 % en la suma de los diámetros de las lesiones diana (incluidos los ejes cortos de cualquier ganglio diana), tomando como referencia la suma del diámetro basal; RC fue la desaparición de todas las lesiones diana no ganglionares, con los ejes cortos de cualquier ganglio linfático diana reducido a <10 mm, la desaparición de todas las lesiones no diana y la normalización de los niveles de marcadores tumorales (si los marcadores tumorales estaban inicialmente por encima del LSN). ).
SD no fue una contracción suficiente para calificar como PR ni un aumento suficiente para calificar como PD, tomando como referencia la suma más pequeña del diámetro desde que se inició el tratamiento.
El porcentaje de participantes que lograron el control de la enfermedad = (número de participantes con RC, PR o SD)/(número de participantes evaluados)*100.
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Línea de base a la DP medida (hasta 29 meses)
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Mejora máxima en la escala de síntomas de cáncer de pulmón (LCSS)
Periodo de tiempo: Línea de base, día 21 de cada ciclo y 30 días después de la última infusión (hasta el ciclo 38, 21 días/ciclo)
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El LCSS constaba de 9 ítems: 6 ítems se centraban en los síntomas del cáncer de pulmón [pérdida de apetito, fatiga, tos, disnea (dificultad para respirar), hemoptisis (sangre en el esputo) y dolor] y 3 ítems eran ítems globales (angustia por los síntomas, interferencia con el nivel de actividad y la calidad de vida global).
Las respuestas de los participantes a cada elemento se midieron utilizando escalas analógicas visuales (VAS) con líneas de 100 mm.
Una puntuación más alta para cualquier ítem representaba un nivel más alto de síntomas/problemas.
El índice promedio de carga de síntomas (ASBI) fue la media de los 6 elementos de síntomas de la LCSS, y el LCSS total fue la media de los 9 elementos de la LCSS.
ASBI y LCSS total no se calcularon para un participante si tenía 1 o más valores faltantes para los 6 y 9 elementos, respectivamente.
La mejora máxima en las puntuaciones de LCSS, ASBI y la puntuación total de LCSS fue la mayor disminución desde el inicio para cada variable, que fue el valor no perdido más pequeño (más negativo o más pequeño positivo) entre todos los cambios de los valores de referencia para cada variable.
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Línea de base, día 21 de cada ciclo y 30 días después de la última infusión (hasta el ciclo 38, 21 días/ciclo)
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Cambio desde el inicio hasta la visita de seguimiento de 30 días en las puntuaciones del estado de salud de la Dimensión 5 del Cuestionario Europeo de Calidad de Vida (EQ-5D)
Periodo de tiempo: Línea de base, 30 días después de la última infusión (hasta el Ciclo 38, 21 días/ciclo)
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El EQ-5D es un instrumento de calidad de vida que consta de 2 partes.
La primera parte (puntuación del índice de estado de salud) permitió a los participantes calificar su estado de salud en 5 dominios de salud: movilidad, autocuidado, actividades habituales, dolor/malestar y ansiedad/depresión utilizando una escala del 1 al 3 (sin problemas, algunos). problemas y problemas extremos, respectivamente).
Estas combinaciones de atributos se convirtieron en una puntuación ponderada del Índice de Estado de Salud de acuerdo con un algoritmo basado en la población del Reino Unido; los valores posibles para la puntuación del Índice de Estado de Salud oscilaron entre -0,59 (problemas graves en las 5 dimensiones) y 1,0 (ningún problema en ninguna dimensión).
La segunda parte del EQ-5D fue una VAS que permitió a los participantes calificar su estado de salud actual.
Las posibles puntuaciones EQ-5D VAS oscilaron entre 0 (peor estado de salud imaginable) y 100 (mejor estado de salud imaginable).
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Línea de base, 30 días después de la última infusión (hasta el Ciclo 38, 21 días/ciclo)
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Concentraciones séricas máximas y mínimas (Cmax y Cmin) de ramucirumab
Periodo de tiempo: Antes de la infusión y 1 hora después de la infusión durante 4 y 8 (ciclos 3 y 5 a los 21 días/ciclo)
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Antes de la infusión y 1 hora después de la infusión durante 4 y 8 (ciclos 3 y 5 a los 21 días/ciclo)
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Número de participantes con anticuerpos anti-ramucirumab
Periodo de tiempo: Línea de base, antes de la infusión para las semanas 4 y 8 (ciclos 3 y 5) y 30 días después de la última infusión (hasta el ciclo 38, 21 días/ciclo)
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Se informa el número de participantes que tuvieron anticuerpos antidrogas (ADA) emergentes del tratamiento o del seguimiento.
Los participantes con ADA emergentes del tratamiento se definieron como participantes que tenían cualquier muestra desde el inicio hasta la preinfusión del Ciclo 5 que era un aumento de 4 veces (aumento de 2 diluciones) en el título de inmunogenicidad sobre el título inicial, o participantes que dieron negativo al inicio y post-basal positivo (a título de ≥1:20).
Los participantes con ADA emergente de seguimiento se definieron como participantes que tuvieron cualquier muestra durante los 30 días posteriores a la última infusión que fue un aumento de 4 veces (aumento de 2 diluciones) en el título de inmunogenicidad sobre el título inicial.
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Línea de base, antes de la infusión para las semanas 4 y 8 (ciclos 3 y 5) y 30 días después de la última infusión (hasta el ciclo 38, 21 días/ciclo)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Número de participantes que tuvieron eventos adversos emergentes del tratamiento (TEAE) o fallecieron
Periodo de tiempo: Primera perfusión hasta 30 días después de la última perfusión (hasta el Ciclo 38, 21 días/ciclo)
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Los datos presentados son el número de participantes que experimentaron al menos 1 TEAE, TEAE de grado 3, 4 o 5, evento adverso grave (SAE) emergente del tratamiento, TEAE que condujo a la interrupción del tratamiento del estudio (ramucirumab/placebo o docetaxel) y TEAE que lleva a la muerte.
Los eventos clínicamente significativos se definieron como EAG emergentes del tratamiento y otros eventos adversos (EA) no graves, independientemente de la causalidad.
En el módulo Eventos adversos informados se encuentra un resumen de los SAE y otros EA no graves, independientemente de la causalidad.
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Primera perfusión hasta 30 días después de la última perfusión (hasta el Ciclo 38, 21 días/ciclo)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2010
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de agosto de 2016
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2010
Publicado por primera vez (Estimar)
23 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
- Ramucirumab
- Anticuerpos Monoclonales
Otros números de identificación del estudio
- 13852
- I4T-MC-JVBA (Otro identificador: Eli Lilly and Company)
- 2010-021297-11 (Número EudraCT)
- CP12-1027 (Otro identificador: ImClone Trial Number)
- CTRI/2011/08/001942 (Identificador de registro: Clinical Trials Registry India)
Plan de datos de participantes individuales (IPD)
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SÍ
Descripción del plan IPD
Los datos anónimos a nivel de paciente individual se proporcionarán en un entorno de acceso seguro tras la aprobación de una propuesta de investigación y un acuerdo de intercambio de datos firmado.
Marco de tiempo para compartir IPD
Los datos están disponibles 6 meses después de la publicación principal y la aprobación de la indicación estudiada en los EE. UU. y la UE, lo que ocurra más tarde.
Los datos estarán indefinidamente disponibles para solicitarlos.
Criterios de acceso compartido de IPD
Una propuesta de investigación debe ser aprobada por un panel de revisión independiente y los investigadores deben firmar un acuerdo de intercambio de datos.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de pulmón de células no pequeñas
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Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos
Ensayos clínicos sobre Ramucirumab
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Shanghai Henlius BiotechTerminadoVoluntarios masculinos sanosPorcelana
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Eli Lilly and CompanyParexelTerminado
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.TerminadoCáncer gástrico | Cáncer de pulmón de células no pequeñas | Cáncer colonrectalPorcelana
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyTerminado
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Yale UniversityRetiradoCarcinoma de células de transiciónEstados Unidos
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Eli Lilly and CompanyTerminadoCarcinoma hepatocelularEstados Unidos, Canadá, Bélgica, Alemania, Israel, Corea, república de, España, Australia, Austria, Brasil, Francia, Italia, Japón, Portugal, Taiwán, Rumania, Bulgaria, República Checa, Finlandia, Hong Kong, Hungría, Países Bajos, Noruega y más
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Eli Lilly and CompanyTerminadoGlioblastoma multiforme del adultoEstados Unidos
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Eli Lilly and CompanyTerminadoCarcinoma hepatocelularEstados Unidos
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Sun Yat-sen UniversityAún no reclutandoAdenocarcinoma de la unión gastroesofágica | Cáncer gástrico avanzado | Ramucirumab | Fruquintinib