Un estudio de abemaciclib (LY2835219) en participantes con cáncer de pulmón con mutación KRAS previamente tratado (JUNIPER)
19 de enero de 2026 actualizado por: Eli Lilly and Company
JUNIPER: Un estudio aleatorizado de fase 3 de abemaciclib más la mejor atención de apoyo versus erlotinib más la mejor atención de apoyo en pacientes con NSCLC en estadio IV con una mutación detectable de KRAS que han progresado después de la quimioterapia a base de platino
El objetivo principal de este estudio es evaluar qué tan seguro y eficaz es el fármaco del estudio conocido como abemaciclib en participantes con cáncer de pulmón.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
453
Fase
- Fase 3
Acceso ampliado
Aprobado en venta al público.
Ver registro de acceso ampliado.
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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Berlin, Alemania, 14165
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Gera, Alemania, 07548
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Großhansdorf, Alemania, 22927
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Hamburg, Alemania, 21075
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Hanover, Alemania, 30459
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Heidelberg, Alemania, 69126
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Immenhausen, Alemania, 34376
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Nuremberg, Alemania, 90419
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Regensburg, Alemania, 93053
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Rosenheim, Alemania, 83022
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Tübingen, Alemania, 72076
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Ulm, Alemania, 89081
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Berazategui, Argentina, B1884BBF
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Ciudad Autonoma Buenos Aires, Argentina, 1093
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Ciudad Autonoma Buenos Aires, Argentina, 1025
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Ciudad Autonoma Buenos Aires, Argentina, C1181AAX
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000DSV
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Viedma, Argentina, 8500
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Graz, Austria, 8036
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Linz, Austria, 4020
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Linz, Austria, 4021
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Salzburg, Austria, 5020
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Ijuí, Brasil, 98700 000
- Associacao Hospital de Caridade Ijui
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Lajeados, Brasil, 95900-000
- Hospital Bruno Born
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Porto Alegre, Brasil, 90610-970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio de Janeiro, Brasil, 20231-050
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Salvador, Brasil, 41253-190
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Sao Jose Rio Preto, Brasil, 15090-000
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São Paulo, Brasil, 01246000
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São Paulo, Brasil, 01509-010
- Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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Calgary, Canadá, T2N 4N2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Edmonton, Canadá, T6G 1Z2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Montreal, Canadá, H2L 4M1
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Toronto, Canadá, M4N 3M5
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Vancouver, Canadá, V5Z 4E6
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Winnipeg, Canadá, R3A 1M3
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Goyang-si, Corea del Sur, 10408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Incheon, Corea del Sur, 21565
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Seoul, Corea del Sur, 03722
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Seoul, Corea del Sur, 05505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul, Corea del Sur, 06351
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Seoul, Corea del Sur, 06591
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seowon-Gu, Corea del Sur, 28644
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Suwon, Corea del Sur, 16247
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Ulsan, Corea del Sur, 44033
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A Coruña, España, 15006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, España, 08003
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L'Hospitalet de Llobregat, España, 08907
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, España, 28041
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Madrid, España, 28040
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Madrid, España, 28050
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Málaga, España, 29010
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Seville, España, 41013
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Valencia, España, 46026
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
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Jonesboro, Arkansas, Estados Unidos, 72401
- St. Bernards Medical Center
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope National Medical Center
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La Jolla, California, Estados Unidos, 92037
- University of California - San Diego
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Loma Linda, California, Estados Unidos, 92350
- Loma Linda University School of Medicine
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Los Angeles, California, Estados Unidos, 90024
- SMO TRIO -Translational Research
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Los Angeles, California, Estados Unidos, 90024
- CBCC Global Research, Inc.
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Los Angeles, California, Estados Unidos, 90024
- Central Coast Medical Oncology Corporation
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Los Angeles, California, Estados Unidos, 90024
- Fort Wayne Oncology & Hematology
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Los Angeles, California, Estados Unidos, 90024
- St. Joseph Heritage Medical Group
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Los Angeles, California, Estados Unidos, 90024
- UCLA Department of Medicine-Hematology/Oncology
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Los Angeles, California, Estados Unidos, 90095
- Cancer Care Associates Medical Group
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Sacramento, California, Estados Unidos, 95816
- Dignity Health Care Institute
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Colorado
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Englewood, Colorado, Estados Unidos, 80112
- SMO Catholic Health Initiatives
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Englewood, Colorado, Estados Unidos, 80112
- Alegent Immanuel Cancer Center
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Englewood, Colorado, Estados Unidos, 80112
- Jewish Hospital
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Englewood, Colorado, Estados Unidos, 80112
- Oncology Hematology West
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Englewood, Colorado, Estados Unidos, 80112
- St Joseph Cancer Center
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Englewood, Colorado, Estados Unidos, 80112
- St. Francis Medical Center
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Medical Oncology Hematology Consultants
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Boca Raton Regional Hospital
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Daytona Beach, Florida, Estados Unidos, 32114
- Halifax Medical Center
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Pembroke Pines, Florida, Estados Unidos, 33028
- Memorial Cancer Institute
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Tampa, Florida, Estados Unidos, 33612-9497
- H Lee Moffitt Cancer Center
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Georgia
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Athens, Georgia, Estados Unidos, 30607
- University Cancer & Blood Center, LLC
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Illinois
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Harvey, Illinois, Estados Unidos, 60426
- Ingalls Memorial Hospital
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, P.A.
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville
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Maryland
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Bethesda, Maryland, Estados Unidos, 20889
- Walter Reed National Military Medical Center
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Massachusetts
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Framingham, Massachusetts, Estados Unidos, 01701
- Metro-West and Greater Boston CNS Research
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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Missouri
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Springfield, Missouri, Estados Unidos, 65807
- Mercy Medical Research Institute
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Montana
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Research Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New York
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Johnson City, New York, Estados Unidos, 13790
- Broome Oncology
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medical College
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Oncology Hematology Care Inc
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74146
- Oklahoma Cancer Specialists & Research Institute, LLC
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Providence Cancer Center Oncology Hematology Care
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Hillman Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401
- Roper St. Francis Healthcare
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, Estados Unidos, 37203
- Tennessee Oncology PLLC
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Nashville, Tennessee, Estados Unidos, 37203
- Chattanooga Oncology Hematology Associates
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Texas
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Dallas, Texas, Estados Unidos, 75230
- Mary Crowley Cancer Research Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84106
- Utah Cancer Specialists
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- University of Vermont Medical Center
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Washington
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Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinical Hematology & Oncology
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Seattle, Washington, Estados Unidos, 98104
- Swedish Medical Center
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Valley, Washington, Estados Unidos, 99216
- Cancer Care Northwest
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Bron, Francia, 69677
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dijon, Francia, 21034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 38043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Marseille, Francia, 13015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poitiers, Francia, 86021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rennes, Francia, 35033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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-Brieuc, Francia, 22027
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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-Priest-en-Jarez, Francia, 42270
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Vantoux, Francia, 57070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 11527
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 11522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 18537
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heraklion, Grecia, 71110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pátrai, Grecia, 26504
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Holon, Israel, 5822012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 9112001
- Hadassah Medical Center - Ein Karem
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Petah Tikva, Israel, 4941492
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Litwinsky, Israel, 5265601
- Sheba medical center
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Catania, Italia, 95125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Genova, Italia, 16132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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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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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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Amagasaki, Japón, 660-0892
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Asahikawa, Japón, 070-8644
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bunkyō City, Japón, 113-8431
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bunkyō City, Japón, 113-8677
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Japón, 811-1395
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Habikino, Japón, 583-8588
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hirakata, Japón, 573-1191
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hiroshima, Japón, 734-8551
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyōgo, Japón, 6608550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanazawa, Japón, 920-8641
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kashiwa, Japón, 277 8577
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kishiwada, Japón, 596-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kitaadachi-Gun, Japón, 362-0806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kobe, Japón, 650-0047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kurashiki, Japón, 710-8602
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kōtoku, Japón, 135-8550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Matsuyama, Japón, 791-0280
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki, Japón, 852-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagoya, Japón, 464-8681
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagoya, Japón, 466-8560
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Natori, Japón, 981-1293
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Okayama, Japón, 700-8558
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japón, 545-8586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japón, 534-0021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japón, 537-8511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sakai, Japón, 5918555
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sayama, Japón, 589-8511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sendai, Japón, 980-0873
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shinjuku-ku, Japón, 160-0023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sunto-Gun, Japón, 411-8777
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ube, Japón, 755-0241
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utsunomiya, Japón, 320-0834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wakayama, Japón, 641-8510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yokohama, Japón, 236-0004
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yonago, Japón, 683-0826
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yufu-shi, Japón, 8795593
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Polonia, 80-219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lodz, Polonia, 90-242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Olsztyn, Polonia, 10-357
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Radom, Polonia, 26-617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szczecin, Polonia, 70-891
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beijing, Porcelana, 100071
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beijing, Porcelana, 100021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Beijing, Porcelana, 100730
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Changchun, Porcelana, 130012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changzhou, Porcelana, 213000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chengdu, Porcelana, 610041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Haikou, Porcelana, 570311
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hangzhou, Porcelana, 310022
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hefei, Porcelana, 230001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nanning, Porcelana, 530021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shanghai, Porcelana, 200030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shenyang, Porcelana, 100042
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Juan, Puerto Rico, 00921-3201
- VA Caribbean Healthcare System
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Baia Mare, Rumania, 430031
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest, Rumania, 022328
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cluj-Napoca, Rumania, 400015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cluj-Napoca, Rumania, 400058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Craiova, Rumania, 200347
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkhangelsk, Rusia, 163045
- Arkhangelsk Regional Clinical Oncology Dispensary
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Chelyabinsk, Rusia, 454048
- Private clinic "Evimed"
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Krasnodar, Rusia, 350086
- Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
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Kursk, Rusia, 305035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Rusia, 115478
- Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
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Saint Petersburg, Rusia, 198255
- Saint-Petersburg City Clinical Oncology Dispensary
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Saint Petersburg, Rusia, 197758
- St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
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Ufa, Rusia, 450054
- Republic clinical oncology dispensary of MoH of Bashkortostan Republic
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Volzhskiy, Rusia, 404130
- Volgograd Regional Clinical Oncology Dispensary
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Chiayi City, Taiwán, 613
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung City, Taiwán, 83301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung City, Taiwán, 82445
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwán, 40447
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwán, 404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tainan, Taiwán, 70403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Taiwán, 10449
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Taiwán, 11217
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Taiwán, 10002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zhonghe, Taiwán, 235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 06100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 06490
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Antalya, Turquía (Türkiye), 07059
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Edirne, Turquía (Türkiye), 22030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 34020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 34098
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 34890
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Turquía (Türkiye), 35100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dnipropetrovsk, Ucrania, 49102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kharkiv, Ucrania, 61070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kryvyi Rih, Ucrania, 50048
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyiv, Ucrania, 04107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lutsk, Ucrania, 63000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poltava, Ucrania, 36011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sumy, Ucrania, 40005
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Uzhhorod, Ucrania, 88000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vinnitsa, Ucrania, 21029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
Descripción
Criterios de inclusión:
- Tener un diagnóstico confirmado de cáncer de pulmón de células no pequeñas (NSCLC) en estadio IV según el Manual del Comité Conjunto Estadounidense sobre Estadificación del Cáncer.
- Se determinó que tiene mutaciones detectables en los codones 12 o 13 del oncogén del sarcoma de rata Kirsten (KRAS) mediante un ensayo de investigación en el laboratorio central del estudio. Se permitirá un resultado de mutación KRAS positivo en los codones 12 o 13 del oncogén KRAS del tejido tumoral por laboratorio local en no más del 10% de los participantes aleatorizados.
- Ha progresado después de la quimioterapia basada en platino (con o sin terapia de mantenimiento) Y ha recibido una terapia adicional que puede incluir un inhibidor del punto de control inmunológico u otra terapia contra el cáncer para la enfermedad avanzada y/o metastásica O el médico lo considera no elegible para recibir más quimioterapia estándar de segunda línea. Participantes que hayan progresado después de una quimioterapia basada en platino y un inhibidor de puntos de control inmunológico (inmunoterapia), p. pembrolizumab o nivolumab solos o en combinación con otros agentes son elegibles.
- Tener una enfermedad medible según lo definido por los Criterios de evaluación de respuesta en tumores sólidos (RECIST 1.1).
- Tener un estado funcional (PS) de 0 a 1 en la escala del Eastern Cooperative Oncology Group (ECOG).
- Haber descontinuado todas las terapias previas para el cáncer (incluidas quimioterapia, radioterapia, inmunoterapia y terapia en investigación) durante al menos 21 días para agentes mielosupresores o 14 días para agentes no mielosupresores antes de recibir el fármaco del estudio.
Criterio de exclusión:
- Haber recibido tratamiento con un medicamento que no haya recibido aprobación regulatoria para ninguna indicación dentro de los 14 o 21 días posteriores a la dosis inicial del fármaco del estudio para un agente mielosupresor o no mielosupresor, respectivamente.
- Tiene antecedentes personales de cualquiera de las siguientes afecciones: presíncope o síncope de etiología cardiovascular o inexplicable, arritmia ventricular (incluidas, entre otras, taquicardia ventricular y fibrilación ventricular) o paro cardíaco repentino.
- Tener presencia de metástasis en el sistema nervioso central (SNC) inestable. Se permiten antecedentes de metástasis en el SNC o metástasis estables en el SNC (ya no requieren terapia activa, como medicamentos esteroides). Los participantes con antecedentes de metástasis en el SNC deben someterse a una exploración cerebral (por ejemplo, una resonancia magnética [MRI]) dentro de los 28 días posteriores a la aleatorización para documentar la estabilidad, incluso si no ha habido cambios en los síntomas.
- Haber completado o retirado previamente de este estudio o de cualquier otro estudio que investigue inhibidores de la quinasa 4 dependiente de ciclina (CDK4) y de la quinasa 6 (CDK6), o haber recibido tratamiento previo con inhibidores de CDK4 y CDK6.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Abemaciclib
200 miligramos (mg) de abemaciclib administrados por vía oral cada 12 horas más el mejor cuidado de apoyo (BSC) los días 1 a 28 (ciclos de 28 días).
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Administrado por vía oral
Otros nombres:
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Comparador activo: Erlotinib
150 mg de erlotinib administrados por vía oral cada 24 horas más BSC los días 1 a 28 (ciclos de 28 días).
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Administrado por vía oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Supervivencia general (SG)
Periodo de tiempo: Desde la fecha de aleatorización hasta la fecha de muerte por cualquier causa (hasta 32 meses)
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OS definida desde la fecha de aleatorización hasta la fecha de muerte por cualquier causa.
Para cada participante del que no se sabe que haya muerto en la fecha límite de inclusión de datos para el análisis de supervivencia general, el tiempo de SG se censuró en la última fecha en que se sabe que el participante está vivo.
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Desde la fecha de aleatorización hasta la fecha de muerte por cualquier causa (hasta 32 meses)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Porcentaje de participantes con respuesta completa (CR) o respuesta parcial (PR) (tasa de respuesta objetiva [ORR])
Periodo de tiempo: Desde la fecha de aleatorización hasta la progresión objetiva (hasta 32 meses)
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La ORR fue el porcentaje de participantes que lograron una mejor respuesta general (BOR) de respuesta completa (CR) o respuesta parcial (PR) según los Criterios de evaluación de respuesta en tumores sólidos (RECIST) v1.1.
RC definida como la desaparición de todas las lesiones diana y no diana y la ausencia de aparición de nuevas lesiones.
La PR se definió como una disminución de al menos el 30% en la suma de los diámetros más largos (LD) de las lesiones diana (tomando como referencia la suma inicial de LD), la ausencia de progresión de las lesiones no diana y la ausencia de aparición de nuevas lesiones.
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Desde la fecha de aleatorización hasta la progresión objetiva (hasta 32 meses)
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Supervivencia libre de progresión (PFS)
Periodo de tiempo: Desde la fecha de aleatorización hasta la progresión de la enfermedad o la muerte por cualquier causa (hasta 32 meses)
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La SSP se define como desde la fecha de aleatorización hasta la primera evidencia de progresión de la enfermedad según lo definido por RECIST v1.1 o muerte por cualquier causa.
La Enfermedad Progresiva (EP) fue al menos un aumento del 20% en la suma de los diámetros de las lesiones diana, siendo la referencia la suma más pequeña en el estudio y un aumento absoluto de al menos 5 mm, o progresión inequívoca de las lesiones no diana, o 1 o más lesiones nuevas.
Si un participante no tiene una evaluación inicial completa de la enfermedad, entonces el tiempo de PFS se censuró en la fecha de la primera dosis, independientemente de si se ha observado o no progresión de la enfermedad o muerte determinada objetivamente en el participante.
Si no se sabía que un participante había muerto o tenía una progresión objetiva en la fecha límite de inclusión de datos para el análisis, el tiempo de PFS se censuró en la última fecha adecuada de evaluación del tumor.
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Desde la fecha de aleatorización hasta la progresión de la enfermedad o la muerte por cualquier causa (hasta 32 meses)
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Cambio con respecto al valor inicial en la puntuación del cáncer de pulmón del Inventario de síntomas del MD Anderson (MDASI-LC)
Periodo de tiempo: Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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El MDASI-LC incluyó 22 ítems + 3 ítems adicionales específicos del ensayo, lo que dio como resultado 6 puntuaciones de constructo único recopiladas e informadas que incluyen síntomas centrales (13 ítems), interferencia (6 ítems), cáncer de pulmón (3 ítems) y resultados únicos específicos del ensayo para dolor de cabeza, diarrea y sarpullido.
Se calculó una puntuación compuesta de 2 constructos núcleo + síntoma de cáncer de pulmón (16 ítems).
Los datos de las 7 puntuaciones se recopilaron mediante una escala de calificación numérica de 11 puntos anclada en 0 (ausente o no interfiere) y 10 (tan malo como puedas imaginar o interfirió por completo).
El rango de medición fue 10 (puntuación máxima-puntuación mínima).
La regresión de medidas repetidas de modelo mixto (MMRM) con covariables para tratamiento, visita, tratamiento*visita y puntuación inicial predijo las diferencias medias de mínimos cuadrados (LS) entre grupos con respecto al valor inicial.
El cambio negativo a nivel de grupo desde el inicio indicó una mejora del grupo.
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Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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Farmacocinética (PK): área bajo la curva de concentración versus tiempo durante 1 intervalo de dosificación en estado estacionario
Periodo de tiempo: Día 1 del ciclo 1 al ciclo 3 (ciclos de 28 días)
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La PK está determinada por el área bajo la curva de concentración plasmática versus tiempo durante 1 intervalo de dosificación en estado estacionario.
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Día 1 del ciclo 1 al ciclo 3 (ciclos de 28 días)
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Cambio desde el inicio en la calidad de vida europea - 5 dimensiones - Puntuación de 5 niveles (EQ-5D-5L)
Periodo de tiempo: Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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Hay cinco niveles de respuesta en un continuo de bueno a malo del 1 al 5, correspondiente a ninguno, leve, moderado, severo y extremo/incapaz de hacerlo.
Se utilizó el método de cruce de peatones desarrollado por EuroQol para convertir el EQ-5D-5L, utilizando ponderaciones del Reino Unido (Reino Unido), dimensiones de salud (movilidad, autocuidado, actividades habituales, dolor/malestar y ansiedad/depresión) en un único índice. valor; las dimensiones no se puntúan por separado.
El índice se marca como faltante cuando faltan ≥1 dimensiones.
Las puntuaciones del índice para los patrones de respuesta se basaron en la salud total hasta la muerte y se asignaron valores negativos a los patrones de respuesta/estados de salud considerados peores que la muerte.
Al mejor patrón se le asigna el valor de índice de 1,0; al peor patrón se le asigna un valor de índice de -0,594.
Para el índice se estimaron las diferencias entre grupos en el cambio previsto por regresión con respecto a la puntuación inicial.
El valor medio de LS se controló para Tratamiento, visita, Tratamiento*Visita y valor inicial.
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Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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Utilización de recursos: porcentaje de participantes hospitalizados
Periodo de tiempo: Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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La utilización de recursos es el porcentaje de participantes que fueron hospitalizados.
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Desde la fecha de aleatorización hasta el final del estudio (hasta 32 meses)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
- Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Goskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.
- Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.
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 (Actual)
3 de octubre de 2014
Finalización primaria (Actual)
15 de septiembre de 2017
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2014
Publicado por primera vez (Estimado)
2 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de febrero de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de enero de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Quinazolina
- Clorhidrato de erlotinib
- abemaciclib
Otros números de identificación del estudio
- 15296
- I3Y-MC-JPBK (Otro identificador: Eli Lilly and Company)
- 2013-004662-33 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los datos anonimizados 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 aprobación de la indicación estudiada en los EE. UU. y la UE, lo que ocurra más tarde.
Los datos estarán disponibles indefinidamente para su solicitud.
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. .