Um estudo de quimioterapia e ramucirumab versus quimioterapia isolada em participantes com câncer de pulmão de células não pequenas (NSCLC) de segunda linha que receberam quimioterapia de primeira linha à base de platina
10 de setembro de 2019 atualizado por: Eli Lilly and Company
Um estudo randomizado, duplo-cego, de fase 3 de docetaxel e ramucirumab versus docetaxel e placebo no tratamento do câncer de pulmão de células não pequenas em estágio IV após a progressão da doença após uma terapia anterior à base de platina
O objetivo do estudo é comparar a sobrevida dos participantes que receberam quimioterapia e ramucirumab versus quimioterapia isolada como tratamento de segunda linha para NSCLC após quimioterapia de primeira linha à base de platina.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1253
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Augsburg, Alemanha, 86150
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Bad Soden, Alemanha, 65812
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Bielefeld, Alemanha, 33611
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Dresden, Alemanha, 01307
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Frankfurt, Alemanha, 60596
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Gerlingen, Alemanha, 70839
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Großhansdorf, Alemanha, 22927
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Halle, Alemanha, 06120
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Heidelberg, Alemanha, 69126
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Immenhausen, Alemanha, 34376
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Oldenburg, Alemanha, 26121
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Ulm, Alemanha, 89081
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Villingen-Schwenningen, Alemanha, 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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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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Barcelona, Espanha, 08003
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Girona, Espanha, 17007
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Las Palmas De Gran Canaria, Espanha, 35016
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Madrid, Espanha, 28050
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Mataró, Espanha, 08304
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Pamplona, Espanha, 31008
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Pozuelo De Alarcon, Espanha, 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
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
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Portsmouth, New Hampshire, Estados Unidos, 03801
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
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New York
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Bronx, New York, Estados Unidos, 10467
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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
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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
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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
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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
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Dallas, Texas, Estados Unidos, 75231
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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
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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, Federação Russa, 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, Federação Russa, 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, Federação Russa, 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, França, 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, França, 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, França, 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, França, 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, França, 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, França, 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, França, 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, Grécia, 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, Grécia, 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, Grécia, 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, Grécia, 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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Amsterdam, Holanda, 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, Holanda, 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, Holanda, 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, Holanda, 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, Holanda, 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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Budapest, Hungria, 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, Hungria, 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, Hungria, 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, Hungria, 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, Hungria, 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, Hungria, 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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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, Itália, 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, Itália, 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, Itália, 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, Itália, 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, Itália, 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, Itália, 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, Itália, 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, Itália, 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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Noruega, 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, Noruega, 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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Grafton, Nova Zelândia, 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, Nova Zelândia, 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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Ankara, Peru, 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, Peru, 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, Peru, 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, Peru, 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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Gdansk, Polônia, 80-219
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Gdynia, Polônia, 81-519
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Glucholazy, Polônia, 48-340
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Krakow, Polônia, 31-202
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Lodz, Polônia, 90-242
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Opole, Polônia, 45-060
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Otwock, Polônia, 05-400
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Poznan, Polônia, 60-693
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Bayamon, Porto 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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Incheon, Republica da Coréia, 405-760
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Seoul, Republica da Coréia, 120-752
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Suwon-City, Republica da Coréia, 442-723
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Bucharest, Romênia, 022328
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Cluj-Napoca, Romênia, 400058
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Iasi, Romênia, 700106
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Eskilstuna, Suécia, 63188
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Linkoping, Suécia, 58185
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Lund, Suécia, 22185
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Solna, Suécia, 17176
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Basel, Suíça, CH-4031
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Bern, Suíça, CH-3010
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Fribourg, Suíça, 1708
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Luzern, Suíça, CH-6000
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Zurich, Suíça, CH-8091
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Kaohsiung, Taiwan, 813
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Kuei Shan Hsiang, Taiwan, 33305
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Neihu Taipei, Taiwan, 114
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Niao Sung Hsiang, Taiwan, 833
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 11031
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Graz, Áustria, 8036
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Grimmenstein, Áustria, 2840
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Vienna, Áustria, A-1140
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Wels, Áustria, 4600
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Bangalore, Índia, 560099
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Cuttack, Índia, 753007
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Delhi, Índia, 110085
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Jaipur, Índia, 302017
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Kochin, Índia, 628040
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Madurai, Índia, 625020
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Mumbai, Índia, 400 012
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Pune, Índia, 411001
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Trivandrum, Índia, 695 011
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Critério de inclusão:
- Progressão da doença durante ou após uma quimioterapia de primeira linha à base de platina com ou sem terapia de manutenção
- Bevacizumabe prévio como terapia de primeira linha e/ou manutenção é permitido
- Consentimento informado assinado
- Status de desempenho do Eastern Cooperative Oncology Group (ECOG) de 0-1
- NSCLC confirmado histologicamente ou citologicamente
- Doença de NSCLC estágio IV
- Os participantes têm doença mensurável ou não mensurável
Função adequada dos órgãos, definida como:
- Bilirrubina total menor ou igual ao limite superior do normal (ULN),
- Aspartato Aminotransferase (AST) e Alanina Aminotransaminase (ALT) menor ou igual a 2,5 x LSN, ou menor ou igual a 5 x LSN se a elevação da transferase for devida a metástases hepáticas,
- Creatinina sérica menor ou igual a 1,5 x LSN ou depuração de creatinina calculada maior ou igual a 50 mililitros por minuto (ml/min) (de acordo com a fórmula de Cockcroft-Gault ou equivalente e/ou coleta de urina de 24 horas),
- Contagem Absoluta de Neutrófilos (ANC) maior ou igual a 1,5 x 10^3/microlitros (µL), hemoglobina maior ou igual a 10,0 gramas/decilitro (g/dL) e plaquetas maiores ou iguais a 100 x 10^3 /µL,
- Função de coagulação adequada conforme definido pela Razão Normalizada Internacional (INR) menor ou igual a 1,5, ou tempo de protrombina e tempo de tromboplastina parcial menor ou igual a 1,5 x LSN.
- O participante não tem cirrose no nível de Child-Pugh B (ou pior) ou cirrose (qualquer grau) e história de encefalopatia hepática ou ascite clinicamente significativa resultante de cirrose. Ascite clinicamente significativa é definida como ascite resultante de cirrose e que requer tratamento contínuo com diuréticos e/ou paracentese.
- A proteína urinária é menor ou igual a 1+ na vareta ou exame de urina de rotina. Se a vareta de urina ou a análise de rotina indicar proteinúria maior ou igual a 2+, uma urina de 24 horas deve ser coletada e deve demonstrar menos de 1.000 miligramas (mg) de proteína.
- Os participantes com potencial reprodutivo (ambos os sexos) devem concordar em usar um método confiável de controle de natalidade (métodos hormonais ou de barreira) durante o período do estudo e pelo menos 12 semanas após a última dose da terapia do estudo
- Expectativa de vida maior ou igual a 3 meses
- A radioterapia prévia é permitida se: No caso de radioterapia torácica, pelo menos 28 dias se passaram desde a conclusão do tratamento com radiação antes da randomização; No caso de tratamento de radiação focal ou paliativo, pelo menos 7 dias se passaram desde o último tratamento de radiação antes da randomização (e desde que 25% ou menos da medula óssea total tenha sido irradiada); No caso de radiação do Sistema Nervoso Central (SNC), pelo menos 14 dias se passaram desde a conclusão do tratamento de radiação antes da randomização
Critério de exclusão:
- Progressão da doença em mais de 1 regime de quimioterapia anterior
- Participantes cujo único tratamento anterior foi um inibidor de tirosina quinase
- O tumor do participante contém total ou parcialmente câncer de pulmão de pequenas células
- Cirurgia de grande porte dentro de 28 dias antes da randomização, ou colocação de dispositivo de acesso venoso subcutâneo dentro de 7 dias antes da randomização. Complicações hemorrágicas pós-operatórias ou complicações da ferida de um procedimento cirúrgico realizado nos últimos 2 meses.
- Tratamento concomitante com outra terapia anticancerígena, incluindo outra quimioterapia, imunoterapia, terapia hormonal, quimioembolização ou terapia direcionada
- A última dose de bevacizumabe deve ser pelo menos 28 dias após a randomização
- A última dose de quimioterapia citotóxica deve ser de pelo menos 14 dias a partir do momento da randomização
- O participante tem metástases do SNC não tratadas. Os participantes com metástases cerebrais tratadas são elegíveis se estiverem clinicamente estáveis em relação à função neurológica, sem esteróides após a irradiação craniana terminar pelo menos 2 semanas antes da randomização ou após a ressecção cirúrgica realizada pelo menos 28 dias antes da randomização. Nenhuma evidência de Grau maior ou igual a 1 hemorragia do SNC com base na ressonância magnética (MRI) pré-tratamento ou na tomografia computadorizada (TC) de contraste IV.
- Evidência documentada radiologicamente de invasão de vasos sanguíneos importantes ou envolvimento por câncer
- Evidência radiográfica de cavitação intratumoral
- História de distúrbio trombótico hereditário ou adquirido não controlado
- Terapia crônica com anti-inflamatórios não esteróides (AINEs) ou outros agentes antiplaquetários; O uso de aspirina em doses de até 325 miligramas por dia (mg/dia) é permitido
- História de hemoptise macroscópica (definida como sangue vermelho brilhante ou maior ou igual a 1/2 colher de chá) dentro de 2 meses antes da randomização
- Insuficiência cardíaca congestiva clinicamente relevante [New York Heart Association (NYHA II-IV)] ou arritmia cardíaca sintomática ou mal controlada
- Qualquer evento trombótico arterial, incluindo infarto do miocárdio, angina instável, acidente vascular cerebral ou ataque isquêmico transitório, dentro de 6 meses antes da randomização
- Hipertensão arterial não controlada maior ou igual a 150 / maior ou igual a 90 milímetros de mercúrio (mm Hg) apesar do tratamento médico padrão
- Ferida grave ou que não cicatriza, úlcera ou fratura óssea dentro de 28 dias antes da randomização
- Distúrbios hemorrágicos significativos, vasculite ou sangramento gastrointestinal de grau 3/4 dentro de 3 meses antes da randomização
- Perfuração gastrointestinal (GI) e/ou fístulas dentro de 6 meses antes da randomização
- Obstrução intestinal, história ou presença de enteropatia inflamatória ou ressecção intestinal extensa Doença de Crohn, colite ulcerativa ou diarreia crônica
- Neuropatia periférica maior ou igual a Grau 2 [Critérios de terminologia comum do National Cancer Institute para eventos adversos (NCI-CTCAE) versão 4.02]
- Doença grave ou condição(ões) médica(s) incluindo, mas não limitado a: Infecção pelo vírus da imunodeficiência humana (HIV) ou doença relacionada à síndrome da imunodeficiência adquirida (AIDS); Infecção clinicamente grave ativa ou descontrolada; Condição médica ou psiquiátrica aguda ou crônica grave ou anormalidade laboratorial que pode aumentar o risco associado à participação no estudo ou à administração do medicamento do estudo
- Alergia conhecida ou reação de hipersensibilidade a qualquer um dos componentes do tratamento
- A participante está grávida ou amamentando
- Tratamento atual ou recente (dentro de 28 dias antes da randomização) com um medicamento ou dispositivo experimental que não tenha recebido aprovação regulatória para qualquer indicação no momento da randomização ou participação em outro ensaio clínico intervencionista
- Terapia prévia com docetaxel
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Ramucirumabe + Docetaxel
|
10 miligramas por quilograma (mg/kg) administrados por via intravenosa (IV) no dia 1 do ciclo de 21 dias até a progressão da doença, toxicidade inaceitável ou outro critério de retirada ser atendido
Outros nomes:
75 miligramas por metro quadrado (mg/m^2) (60 mg/m^2 para os países da Coréia e Taiwan apenas com emenda de protocolo datada de 22 de maio de 2012) administrado IV no dia 1 do ciclo de 21 dias até a progressão da doença, inaceitável toxicidade ou outro critério de retirada for atendido
|
|
Comparador de Placebo: Placebo + Docetaxel
|
75 miligramas por metro quadrado (mg/m^2) (60 mg/m^2 para os países da Coréia e Taiwan apenas com emenda de protocolo datada de 22 de maio de 2012) administrado IV no dia 1 do ciclo de 21 dias até a progressão da doença, inaceitável toxicidade ou outro critério de retirada for atendido
Administrado IV no dia 1 do ciclo de 21 dias até a progressão da doença, toxicidade inaceitável ou outro critério de retirada ser atendido
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sobrevivência geral
Prazo: Randomização até a data da morte por qualquer causa (até 34 meses)
|
A sobrevida global foi o tempo desde a randomização até a data da morte por qualquer causa.
Os participantes que estavam vivos no final do período de acompanhamento (ou perdidos no acompanhamento) foram censurados na última data em que o participante estava vivo.
|
Randomização até a data da morte por qualquer causa (até 34 meses)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tempo de Sobrevivência Livre de Progressão (PFS)
Prazo: Randomização para DP medido ou data de morte por qualquer causa (até 29 meses)
|
O tempo PFS foi o tempo desde a randomização até a data da doença progressiva (DP) objetivamente determinada ou morte por qualquer causa, o que ocorrer primeiro.
De acordo com os Critérios de Avaliação de Resposta em Tumores Sólidos versão 1.1 (RECIST v1.1), a PD foi um aumento de pelo menos 20% na soma dos diâmetros das lesões-alvo, tomando como referência a menor soma no estudo.
Além do aumento relativo de 20%, a soma também deve ter demonstrado um aumento absoluto de pelo menos 5 milímetros (mm).
O aparecimento de 1 ou mais novas lesões e/ou progressão inequívoca de lesões não-alvo existentes também foi considerado progressão.
Os participantes sem PD objetivamente determinado que estavam vivos no final do período de acompanhamento (ou perdidos no acompanhamento) foram censurados na data da última avaliação radiográfica completa do tumor do participante; se nenhuma avaliação radiológica basal ou pós-basal estivesse disponível, o participante era censurado na data da randomização.
|
Randomização para DP medido ou data de morte por qualquer causa (até 29 meses)
|
|
Porcentagem de participantes que alcançaram uma resposta objetiva (taxa de resposta objetiva)
Prazo: Linha de base para DP medida (até 29 meses)
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Os participantes alcançaram uma resposta objetiva se tivessem uma melhor resposta geral de resposta parcial (PR) ou resposta completa (CR).
De acordo com o RECIST v1.1, PR foi definido como uma diminuição de pelo menos 30% na soma dos diâmetros das lesões-alvo (incluindo os eixos curtos de qualquer linfonodo-alvo), tomando como referência o diâmetro da soma da linha de base; CR foi o desaparecimento de todas as lesões alvo não nodais, com os eixos curtos de qualquer linfonodo alvo reduzidos para <10 mm, o desaparecimento de todas as lesões não alvo e a normalização dos níveis de marcadores tumorais [se os marcadores tumorais estivessem inicialmente acima do limite superior limite do normal (LSN)].
A porcentagem de participantes que alcançaram uma resposta objetiva=(número de participantes com CR ou PR)/(número de participantes avaliados)*100.
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Linha de base para DP medida (até 29 meses)
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Porcentagem de participantes que alcançaram o controle da doença (taxa de controle da doença)
Prazo: Linha de base para DP medida (até 29 meses)
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Os participantes alcançaram o controle da doença se tivessem uma melhor resposta geral de PR, CR ou doença estável (SD).
De acordo com o RECIST v1.1, PR foi definido como uma diminuição de pelo menos 30% na soma dos diâmetros das lesões-alvo (incluindo os eixos curtos de qualquer linfonodo-alvo), tomando como referência o diâmetro da soma da linha de base; CR foi o desaparecimento de todas as lesões alvo não nodais, com os eixos curtos de qualquer linfonodo alvo reduzidos para <10 mm, o desaparecimento de todas as lesões não alvo e a normalização dos níveis de marcadores tumorais (se os marcadores tumorais estivessem inicialmente acima do LSN ).
SD não foi contração suficiente para qualificar como PR nem aumento suficiente para qualificar como PD, tomando como referência o menor diâmetro somado desde o início do tratamento.
A porcentagem de participantes que alcançaram o controle da doença=(número de participantes com CR, PR ou SD)/(número de participantes avaliados)*100.
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Linha de base para DP medida (até 29 meses)
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Melhoria Máxima na Escala de Sintomas de Câncer de Pulmão (LCSS)
Prazo: Linha de base, dia 21 de cada ciclo e 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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O LCSS consistia em 9 itens: 6 itens focados em sintomas de câncer de pulmão [perda de apetite, fadiga, tosse, dispnéia (falta de ar), hemoptise (sangue no escarro) e dor] e 3 itens eram itens globais (sintomas de angústia, interferência com nível de atividade e qualidade de vida global).
As respostas dos participantes a cada item foram medidas usando escalas visuais analógicas (VAS) com linhas de 100 mm.
Uma pontuação mais alta para qualquer item representou um nível mais alto de sintomas/problemas.
O Average Symptom Burden Index (ASBI) foi a média dos 6 itens de sintomas do LCSS, e o LCSS Total foi a média de todos os 9 itens do LCSS.
ASBI e Total LCSS não foram computados para um participante se ele/ela tivesse 1 ou mais valores ausentes para os 6 e 9 itens, respectivamente.
A melhora máxima nas pontuações de LCSS, ASBI e pontuação total de LCSS foi a maior diminuição da linha de base para cada variável, que foi o menor (mais negativo ou menor positivo) valor não ausente entre todas as alterações dos valores de linha de base para cada variável.
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Linha de base, dia 21 de cada ciclo e 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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Mudança da linha de base para a visita de acompanhamento de 30 dias no Questionário Europeu de Qualidade de Vida-5 Dimensões (EQ-5D) Pontuações do estado de saúde
Prazo: Linha de base, 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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O EQ-5D é um instrumento de qualidade de vida que consiste em 2 partes.
A primeira parte (pontuação do Health State Index) permitiu aos participantes classificar seu estado de saúde em 5 domínios de saúde: mobilidade, autocuidado, atividades habituais, dor/desconforto e ansiedade/depressão usando uma escala de 1 a 3 (nenhum problema, algum problemas e problemas extremos, respectivamente).
Essas combinações de atributos foram convertidas em uma pontuação ponderada do Health State Index de acordo com um algoritmo baseado na população do Reino Unido; os valores possíveis para a pontuação do Health State Index variaram de -0,59 (problemas graves em todas as 5 dimensões) a 1,0 (nenhum problema em qualquer dimensão).
A segunda parte do EQ-5D era uma VAS que permitia aos participantes avaliar sua condição de saúde atual.
As possíveis pontuações EQ-5D VAS variaram de 0 (pior estado de saúde imaginável) a 100 (melhor estado de saúde imaginável).
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Linha de base, 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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Concentrações Séricas Máximas e Mínimas (Cmax e Cmin) de Ramucirumab
Prazo: Antes da infusão e 1 hora após a infusão para 4 e 8 (ciclos 3 e 5 em 21 dias/ciclo)
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Antes da infusão e 1 hora após a infusão para 4 e 8 (ciclos 3 e 5 em 21 dias/ciclo)
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Número de participantes com anticorpos anti-ramucirumabe
Prazo: Linha de base, antes da infusão para a semana 4 e 8 (ciclos 3 e 5) e 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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É relatado o número de participantes que tiveram anticorpos antidrogas (ADA) emergentes do tratamento ou de acompanhamento.
Os participantes com ADA emergente do tratamento foram definidos como participantes que tiveram qualquer amostra da linha de base até a pré-infusão do Ciclo 5 que foi um aumento de 4 vezes (aumento de 2 diluições) no título de imunogenicidade em relação ao título da linha de base, ou participantes que testaram negativo na linha de base e positivo pós-basal (com título ≥1:20).
Os participantes com ADA emergente de acompanhamento foram definidos como participantes que tiveram qualquer amostra durante 30 dias após a última infusão que foi um aumento de 4 vezes (aumento de 2 diluições) no título de imunogenicidade em relação ao título de linha de base.
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Linha de base, antes da infusão para a semana 4 e 8 (ciclos 3 e 5) e 30 dias após a última infusão (até o ciclo 38, 21 dias/ciclo)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Número de participantes que tiveram eventos adversos emergentes do tratamento (TEAEs) ou morreram
Prazo: Primeira infusão até 30 dias após a última infusão (até o Ciclo 38, 21 dias/ciclo)
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Os dados apresentados são o número de participantes que experimentaram pelo menos 1 TEAE, TEAE de Grau 3, 4 ou 5, evento adverso grave emergente do tratamento (SAE), TEAE levando à descontinuação do tratamento do estudo (ramucirumabe/placebo ou docetaxel) e TEAE levando à morte.
Eventos clinicamente significativos foram definidos como SAEs emergentes do tratamento e outros eventos adversos (EAs) não graves, independentemente da causalidade.
Um resumo de EAGs e outros EAs não graves, independentemente da causalidade, está localizado no módulo de Eventos Adversos Relatados.
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Primeira infusão até 30 dias após a última infusão (até o Ciclo 38, 21 dias/ciclo)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2010
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2010
Primeira postagem (Estimativa)
23 de julho de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Fatores imunológicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Docetaxel
- Ramucirumabe
- Anticorpos Monoclonais
Outros números de identificação do estudo
- 13852
- I4T-MC-JVBA (Outro identificador: Eli Lilly and Company)
- 2010-021297-11 (Número EudraCT)
- CP12-1027 (Outro identificador: ImClone Trial Number)
- CTRI/2011/08/001942 (Identificador de registro: Clinical Trials Registry India)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Os dados anônimos individuais do nível do paciente serão fornecidos em um ambiente de acesso seguro após a aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.
Prazo de Compartilhamento de IPD
Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na UE, o que ocorrer mais tarde.
Os dados ficarão indefinidamente disponíveis para solicitação.
Critérios de acesso de compartilhamento IPD
Uma proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Ramucirumabe
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Yonsei UniversityAinda não está recrutandoCâncer de intestino | Câncer da Junção Gastroesofágica (GEJ)
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Eli Lilly and CompanyParexelConcluído
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Pieris Pharmaceuticals, Inc.Ativo, não recrutandoCâncer Gástrico HER2-positivoEstados Unidos, Republica da Coréia
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Fondazione IRCCS Istituto Nazionale dei Tumori,...Recrutamento