Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Estudio de fase 3 de sitravatinib más nivolumab frente a docetaxel en pacientes con cáncer de pulmón de células no pequeñas no escamoso avanzado (SAPPHIRE)

9 de septiembre de 2026 actualizado por: Mirati Therapeutics Inc.

Un estudio aleatorizado de fase 3 de sitravatinib en combinación con nivolumab versus docetaxel en pacientes con cáncer de pulmón no microcítico no escamoso avanzado con progresión de la enfermedad durante o después de la quimioterapia basada en platino y la terapia con inhibidores de puntos de control SAPPHIRE

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

577

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Berka, Alemania, 99437
        • Local Institution - 005-400
      • Berlin, Alemania, 13125
        • Local Institution - 005-418
      • Bonn, Alemania, 53127
        • Local Institution - 005-401
      • Cologne, Alemania, 51109
        • Local Institution - 005-412
      • Essen, Alemania, 45136
        • Local Institution - 005-419
      • Esslingen am Neckar, Alemania, 73730
        • Local Institution - 005-406
      • Gauting, Alemania, 82131
        • Local Institution - 005-403
      • Grohansdorf, Alemania, 22927
        • Local Institution - 005-417
      • Halle, Alemania, 06120
        • Local Institution - 005-408
      • Immenstadt im Allgäu, Alemania, 87509
        • Local Institution - 005-411
      • Kassel, Alemania, 34125
        • Local Institution - 005-416
      • Löwenstein, Alemania, 74245
        • Local Institution - 005-410
      • Lübeck, Alemania, 23538
        • Local Institution - 005-405
      • Mainz, Alemania, 55131
        • Local Institution - 005-414
      • München, Alemania, 81675
        • Local Institution - 005-413
      • München, Alemania, 81925
        • Local Institution - 005-402
  • Bélgica
      • Brasschaat, Bélgica, 2930
        • Local Institution - 005-201
      • Charleroi, Bélgica, 6000
        • Local Institution - 005-200
      • Edegem, Bélgica, 2650
        • Local Institution - 005-206
      • Ghent, Bélgica, 9000
        • Local Institution - 005-202
      • Ghent, Bélgica, 9000
        • Local Institution - 005-207
      • Roeselare, Bélgica, 8800
        • Local Institution - 005-205
      • Ronse, Bélgica, 9600
        • Local Institution - 005-204
      • Yvoir, Bélgica, B-5530
        • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
  • Canadá
      • Québec, Canadá, G1V 4G5
        • Local Institution - 005-258
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N2
        • Local Institution - 005-259
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 6Z8
        • Local Institution - 005-250
      • Saint John, New Brunswick, Canadá, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canadá, L8V 5C2
        • Local Institution - 005-252
      • Toronto, Ontario, Canadá, M5G 2M9
        • Local Institution - 005-251
      • Windsor, Ontario, Canadá, N8W 2X3
        • Local Institution - 005-257
    • Quebec
      • Montreal, Quebec, Canadá, H3A 0G4
        • Local Institution - 005-255
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7N 4H4
        • Saskatoon Cancer Centre
  • España
      • A Coruña, España, 15006
        • Local Institution - 005-807
      • Badalona, España, 08916
        • Local Institution - 005-800
      • Barcelona, España, 08003
        • Local Institution - 005-822
      • Barcelona, España, 08028
        • Local Institution - 005-811
      • Barcelona, España, 08035
        • Local Institution - 005-810
      • Jaén, España, 23007
        • Local Institution - 005-805
      • Las Palmas de Gran Canaria, España, 35016
        • Local Institution - 005-816
      • León, España, 24071
        • Local Institution - 005-817
      • Lugo, España, 27003
        • Local Institution - 005-812
      • Madrid, España, 28006
        • Hospital Universitario La Princesa
      • Madrid, España, 28046
        • Hospital Universitario La Paz
      • Madrid, España, 28006
        • Local Institution - 005-808
      • Madrid, España, 28027
        • Local Institution - 005-819
      • Madrid, España, 28034
        • Local Institution - 005-821
      • Madrid, España, 28040
        • Local Institution - 005-813
      • Madrid, España, 28040
        • Local Institution - 005-815
      • Madrid, España, 28041
        • Local Institution - 005-809
      • Majadahonda, España, 28222
        • Local Institution - 005-806
      • Málaga, España, 29009
        • Local Institution - 005-801
      • Oviedo, España, 33011
        • Local Institution - 005-803
      • Santiago de Compostela, España, 15706
        • Local Institution - 005-823
      • Valencia, España, 46009
        • IVO - Fundacion Instituto Valenciano de Oncologia
      • Valencia, España, 46026
        • Local Institution - 005-804
      • Vigo, España, 36312
        • Local Institution - 005-818
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35243
        • Local Institution - 005-164
      • Huntsville, Alabama, Estados Unidos, 35805
        • Clearview Cancer Institute - Huntsville
    • Arizona
      • Glendale, Arizona, Estados Unidos, 85304
        • Palo Verde Cancer Specialists - Glendale
      • Tucson, Arizona, Estados Unidos, 85745
        • The Oncology Institute of Hope & Innovation - Tucson
      • Yuma, Arizona, Estados Unidos, 85364
        • Yuma Regional Medical Center
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • NEA Baptist Fowler Family Center for Cancer Care
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • Local Institution - 005-174
      • Springdale, Arkansas, Estados Unidos, 72762
        • Highlands Oncology Group - Springdale
    • California
      • Bakersfield, California, Estados Unidos, 93309
        • Comprehensive Blood and Cancer Center - Bakersfield
      • Beverly Hills, California, Estados Unidos, 90211
        • Local Institution - 005-118
      • Fresno, California, Estados Unidos, 93720
        • Local Institution - 005-171
      • Fullerton, California, Estados Unidos, 92835
        • Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
      • Long Beach, California, Estados Unidos, 90813
        • Local Institution - 005-096
      • Los Alamitos, California, Estados Unidos, 90720
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, Estados Unidos, 90017
        • Los Angeles Hematology Oncology Medical Group
      • Los Angeles, California, Estados Unidos, 90095
        • Local Institution - 005-185
      • Newport Beach, California, Estados Unidos, 92663
        • Local Institution - 005-072
      • Northridge, California, Estados Unidos, 91325
        • Local Institution - 005-109
      • Redlands, California, Estados Unidos, 92373
        • Local Institution - 005-177
      • Riverside, California, Estados Unidos, 92501
        • Local Institution - 005-112
      • San Francisco, California, Estados Unidos, 94143
        • University of California San Francisco
      • San Marcos, California, Estados Unidos, 92069
        • Local Institution - 005-176
      • Torrance, California, Estados Unidos, 90505
        • Local Institution - 005-192
      • West Covina, California, Estados Unidos, 91790
        • Local Institution - 005-090
      • Whittier, California, Estados Unidos, 90602
        • Local Institution - 005-105
    • Colorado
      • Lafayette, Colorado, Estados Unidos, 80026
        • Local Institution - 005-097
    • Connecticut
      • Norwich, Connecticut, Estados Unidos, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center
      • Fort Myers, Florida, Estados Unidos, 33901
        • Local Institution - 005-120
      • Hollywood, Florida, Estados Unidos, 33021
        • Memorial Regional Hospital
      • Lakeland, Florida, Estados Unidos, 33805
        • Watson Clinic Cancer and Research Center
      • Miami Beach, Florida, Estados Unidos, 33140
        • Mount Sinai Health System
      • Naples, Florida, Estados Unidos, 34102
        • Local Institution - 005-120E
      • Ocala, Florida, Estados Unidos, 34474
        • Local Institution - 005-079
      • Orlando, Florida, Estados Unidos, 32804
        • Local Institution - 005-104
      • St. Petersburg, Florida, Estados Unidos, 33705
        • SCRI - Florida Cancer Specialists - North Region Research Office
      • Tallahassee, Florida, Estados Unidos, 32308
        • SCRI - Florida Cancer Specialists - Panhandle Research Office
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Local Institution - 005-154
    • Georgia
      • Athens, Georgia, Estados Unidos, 30607
        • University Cancer & Blood Center (UCBC) - Athens
      • Atlanta, Georgia, Estados Unidos, 30318
        • Local Institution - 005-146
      • Columbus, Georgia, Estados Unidos, 31904
        • John B. Amos Cancer Center Research
      • Marietta, Georgia, Estados Unidos, 30060
        • Local Institution - 005-119
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Straub Medical Center
    • Idaho
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Local Institution - 005-191
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60625-3645
        • Local Institution - 005-151
      • Evanston, Illinois, Estados Unidos, 60201
        • Local Institution - 005-110
      • Niles, Illinois, Estados Unidos, 60714
        • Local Institution - 005-198
      • Skokie, Illinois, Estados Unidos, 60077
        • Orchard Healthcare Research
      • Tinley Park, Illinois, Estados Unidos, 60487
        • Healthcare Research Network - Tinley Park
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46804
        • Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office
      • Goshen, Indiana, Estados Unidos, 46526
        • Local Institution - 005-122
      • Indianapolis, Indiana, Estados Unidos, 46237
        • Franciscan Health Cancer Center Indianapolis
      • Lafayette, Indiana, Estados Unidos, 47904
        • Local Institution - 005-150
    • Kansas
      • Westwood, Kansas, Estados Unidos, 66205
        • Local Institution - 005-169
      • Wichita, Kansas, Estados Unidos, 67214
        • Local Institution - 005-098
    • Kentucky
      • Danville, Kentucky, Estados Unidos, 40422
        • Commonwealth Cancer Center - Frankfort
      • Louisville, Kentucky, Estados Unidos, 40241
        • Local Institution - 005-153
    • Maine
      • Scarborough, Maine, Estados Unidos, 04074
        • New England Cancer Specialists - Scarborough
    • Maryland
      • Rockville, Maryland, Estados Unidos, 20850-6535
        • Local Institution - 005-178
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55404
        • Local Institution - 005-127
      • Saint Louis Park, Minnesota, Estados Unidos, 55426-5000
        • Local Institution - 005-159
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39202
        • Jackson Oncology Associates - The Hederman Cancer Center
    • Missouri
      • Bolivar, Missouri, Estados Unidos, 65613
        • Central Care Cancer Center - Bolivar
      • Kansas City, Missouri, Estados Unidos, 64132
        • Kansas City Care Health Center - Research Medical Campus
    • Montana
      • Billings, Montana, Estados Unidos, 59102
        • Sisters of Charity of Leavenworth Health St. Marys
    • Nebraska
      • Grand Island, Nebraska, Estados Unidos, 68803
        • Saint Francis Cancer Treatment Center
      • Omaha, Nebraska, Estados Unidos, 68114
        • Methodist Hospital - Omaha
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89052
        • The Oncology Institute of Hope & Innovation - Henderson
      • Henderson, Nevada, Estados Unidos, 89074
        • Local Institution - 005-152
    • New Jersey
      • Florham Park, New Jersey, Estados Unidos, 07932
        • Local Institution - 005-142
      • Little Silver, New Jersey, Estados Unidos, 07739
        • Local Institution - 005-163
      • Livingston, New Jersey, Estados Unidos, 07039
        • Cooperman Barnabas Medical Center
      • Sparta, New Jersey, Estados Unidos, 07871
        • Regional Cancer Care Associates - Sparta
    • New York
      • Johnson City, New York, Estados Unidos, 13790
        • Local Institution - 005-123
      • Lake Success, New York, Estados Unidos, 11042
        • Local Institution - 005-182
      • Port Jefferson Station, New York, Estados Unidos, 11776
        • New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
      • Stony Brook, New York, Estados Unidos, 11794
        • Local Institution - 005-107
    • Ohio
      • Canton, Ohio, Estados Unidos, 44708
        • Local Institution - 005-196
      • Cincinnati, Ohio, Estados Unidos, 45242
        • USOR - Oncology Hematology Care - Blue Ash
      • Columbus, Ohio, Estados Unidos, 43210
        • Local Institution - 005-181
      • Massillon, Ohio, Estados Unidos, 44646
        • Tricounty Hematology and Oncology - Massillon
      • Toledo, Ohio, Estados Unidos, 43623
        • Local Institution - 005-103
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Local Institution - 005-088
    • Oregon
      • Portland, Oregon, Estados Unidos, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Estados Unidos, 97239
        • Local Institution - 005-073
    • Pennsylvania
      • Horsham, Pennsylvania, Estados Unidos, 19044
        • USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Local Institution - 005-186
    • Tennessee
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137A
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137B
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137C
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137D
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137E
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137F
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137G
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137H
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137I
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137J
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137K
      • Dickson, Tennessee, Estados Unidos, 37055
        • Local Institution - 005-137L
      • Hendersonville, Tennessee, Estados Unidos, 37075
        • Local Institution - 005-137M
      • Memphis, Tennessee, Estados Unidos, 38120
        • Local Institution - 005-195
      • Nashville, Tennessee, Estados Unidos, 37203
        • Local Institution - 005-137
    • Texas
      • Austin, Texas, Estados Unidos, 78745
        • Local Institution - 005-134
      • Beaumont, Texas, Estados Unidos, 77702
        • Local Institution - 005-075
      • Dallas, Texas, Estados Unidos, 75203
        • Local Institution - 005-128
      • Dallas, Texas, Estados Unidos, 75231
        • Local Institution - 005-129
      • Dallas, Texas, Estados Unidos, 75246
        • Local Institution - 005-126
      • Denison, Texas, Estados Unidos, 75020
        • USOR - Texas Oncology Northeast Texas - Denison
      • Denton, Texas, Estados Unidos, 76201
        • Local Institution - 005-124
      • Fort Worth, Texas, Estados Unidos, 76104
        • The Center for Cancer & Blood Disorders - Fort Worth
      • Houston, Texas, Estados Unidos, 77030
        • Oncology Consultants - Texas Medical Center
      • Houston, Texas, Estados Unidos, 77090
        • Millennium Research and Clinical Development
      • Houston, Texas, Estados Unidos, 77070
        • Local Institution - 005-076
      • Irving, Texas, Estados Unidos, 75063
        • USOR - US Oncology Investigational Products Center
      • McKinney, Texas, Estados Unidos, 75071
        • Local Institution - 005-125
      • San Antonio, Texas, Estados Unidos, 78240
        • Texas Oncology - San Antonio Medical Center
      • Sugar Land, Texas, Estados Unidos, 77479
        • USOR - Texas Oncology - Sugar Land
      • Tyler, Texas, Estados Unidos, 75702
        • USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Local Institution - 005-144
      • Fredericksburg, Virginia, Estados Unidos, 24408
        • Hematology Oncology Associates of Fredericksburg
      • Richmond, Virginia, Estados Unidos, 23229
        • Virginia Cancer Institute - West End
    • Washington
      • Bellevue, Washington, Estados Unidos, 98004
        • Overlake Medical Center and Clinics
      • Everett, Washington, Estados Unidos, 98201
        • Local Institution - 005-082
      • Seattle, Washington, Estados Unidos, 98109--1023
        • Local Institution - 005-111
      • Spokane, Washington, Estados Unidos, 99218
        • Local Institution - 005-187
      • Tacoma, Washington, Estados Unidos, 98405
        • Northwest Medical Specialties - Tacoma
      • Tacoma, Washington, Estados Unidos, 98405
        • Local Institution - 005-081
      • Vancouver, Washington, Estados Unidos, 98684
        • Local Institution - 005-136
    • Wisconsin
      • Appleton, Wisconsin, Estados Unidos, 54911
        • ThedaCare Regional Cancer Center
      • Madison, Wisconsin, Estados Unidos, 53792
        • Local Institution - 005-116
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Froedtert Hospital
  • Francia
      • Brest, Francia, 29200
        • Local Institution - 005-307
      • Bron, Francia, 69500
        • Local Institution - 005-310
      • Créteil, Francia, 94000
        • Local Institution - 005-311
      • Dijon, Francia, 21079
        • Local Institution - 005-303
      • Le Mans, Francia, 72037
        • Local Institution - 005-309
      • Limoges, Francia, 87042
        • Local Institution - 005-308
      • Lyon, Francia, 69008
        • Local Institution - 005-317
      • Marseille, Francia, 13009
        • Local Institution - 005-301
      • Marseille, Francia, 13015
        • Local Institution - 005-312
      • Montpellier, Francia, 34298
        • Local Institution - 005-313
      • Mulhouse, Francia, 68100
        • Local Institution - 005-306
      • Paris, Francia, 75018
        • Local Institution - 005-302
      • Rouen, Francia, 76031
        • Local Institution - 005-314
      • Saint-Herblain, Francia, 44805
        • Local Institution - 005-316
      • Strasbourg, Francia, 67200
        • Local Institution - 005-305
      • Villejuif, Francia, 94805
        • Local Institution - 005-304
  • Hungría
      • Budapest, Hungría, 1083
        • Local Institution - 005-454
      • Budapest, Hungría, 1121
        • Local Institution - 005-457
      • Budapest, Hungría, 1122
        • Local Institution - 005-455
      • Farkasgyepű, Hungría, 8582
        • Local Institution - 005-453
      • Győr, Hungría, 9023
        • Local Institution - 005-452
      • Szombathely, Hungría, 9700
        • Local Institution - 005-451
      • Tatabánya, Hungría, 2800
        • Local Institution - 005-450
      • Törökbálint, Hungría, 2045
        • Local Institution - 005-456
  • Israel
      • Afula, Israel, 1834111
        • Local Institution - 005-500
      • Beer Yaakov, Israel, 7030000
        • Local Institution - 005-501
      • Beersheba, Israel, 84101
        • Local Institution - 005-504
      • Holon, Israel, 5822012
        • Local Institution - 005-502
      • Jerusalem, Israel, 9103102
        • Local Institution - 005-507
      • Ramat Gan, Israel, 5265601
        • Local Institution - 005-506
      • Zsfat, Israel, 1311001
        • Local Institution - 005-505
  • Italia
      • Alessandria, Italia, 15121
        • Local Institution - 005-612
      • Bari, Italia, 70124
        • Local Institution - 005-602
      • Catania, Italia, 95123
        • Local Institution - 005-603
      • Cremona, Italia, 26100
        • Local Institution - 005-611
      • Lecce, Italia, 73100
        • Local Institution - 005-608
      • Meldola, Italia, 47014
        • Local Institution - 005-610
      • Milan, Italia, 20141
        • Local Institution - 005-606
      • Monza, Italia, 20900
        • Local Institution - 005-605
      • Naples, Italia, 80131
        • Local Institution - 005-604
      • Parma, Italia, 43126
        • Local Institution - 005-600
      • Piacenza, Italia, 29100
        • Local Institution - 005-607
      • Pisa, Italia, 56126
        • Local Institution - 005-609
      • Roma, Italia, 00144
        • Local Institution - 005-614
      • Varese, Italia, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Países Bajos
      • 's-Hertogenbosch, Países Bajos, 5223 GZ
        • Local Institution - 005-700
      • Amsterdam, Países Bajos, 1066 CX
        • Local Institution - 005-703
      • Amsterdam, Países Bajos, 1081 HV
        • Local Institution - 005-711
      • Breda, Países Bajos, 4818 CK
        • Local Institution - 005-707
      • Dordrecht, Países Bajos, 3318 AT
        • Local Institution - 005-713
      • Groningen, Países Bajos, 9728 NT
        • Local Institution - 005-702
      • Maastricht, Países Bajos, 6229 HX
        • Local Institution - 005-712
      • Nijmegen, Países Bajos, 6525 GA
        • Local Institution - 005-714
      • Rotterdam, Países Bajos, 3015 GD
        • Local Institution - 005-710
      • Rotterdam, Países Bajos, 3045 PM
        • Local Institution - 005-705
      • The Hague, Países Bajos, 2545 AA
        • Local Institution - 005-709
      • Utrecht, Países Bajos, 3543 AZ
        • Local Institution - 005-701
      • Utrecht, Países Bajos, 3584 CX
        • Local Institution - 005-708
      • Zwolle, Países Bajos, 8025 AB
        • Local Institution - 005-706
  • Reino Unido
      • Cardiff, Reino Unido, CF14 2TL
        • Velindre University NHS Trust
      • Cornwall, Reino Unido, TR1 3LJ
        • Local Institution - 005-904
      • Leicester, Reino Unido, LE1 5WW
        • University Hospitals of Leicester NHS Trust
      • London, Reino Unido, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, Reino Unido, NW3 2QG
        • Local Institution - 005-908
      • London, Reino Unido, SW3 6JJ
        • Local Institution - 005-900
      • Manchester, Reino Unido, M20 4BX
        • The Christie NHS Foundation Trust
      • Middlesex, Reino Unido, HA6 2RN
        • Local Institution - 005-903
  • Suiza
      • Bern, Suiza, 3010
        • Inselspital Universitatsspital Bern
      • Geneva, Suiza, 1205
        • Hopitaux Universitaires de Geneve
      • Lausanne, Suiza, 1011
        • Centre Hospitalier Universitaire Vaudois Lausanne
      • Winterthur, Suiza, 8401
        • Kantonsspital Winterthur

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
  • Receipt of at least one but not more than two prior treatment regimens in the advanced setting
  • Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
  • Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
  • Candidate to receive docetaxel as second or third line therapy

Exclusion Criteria:

  • Uncontrolled brain metastases
  • Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
  • Unacceptable toxicity with prior checkpoint inhibitor therapy
  • Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
  • Impaired heart function

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
Experimental: Nivolumab and Sitravatinib

Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.
Biológico: Nivolumab

Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.

Otros nombres:
  • Opdivo
Droga: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Otros nombres:
  • MGCD516
Comparador activo: Docetaxel

Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Droga: Docetaxel

Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Otros nombres:
  • Taxotere

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: From randomization date to date of death due to any cause (Up to approximately 44 months)

OS is defined as time from date of randomization to date of death due to any cause. Patients who did not die on study are censored at the date of the last on-study follow-up that the patient was known to be alive (including follow-up data). Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method.
From randomization date to date of death due to any cause (Up to approximately 44 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Periodo de tiempo: From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 61 months)

An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death).
From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 61 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
Periodo de tiempo: From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 61 months)

An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment.
From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 61 months)
Number of Participants With Maximum Post Baseline Hematology Grade Results
Periodo de tiempo: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)

The severity of hematology results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment.
From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)
Number of Participants With Maximum Post Baseline Chemistry Grade Results
Periodo de tiempo: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)

The severity of chemistry results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Chemistry parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment.
From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)
Objective Response Rate (ORR) Per Central Radiographic Assessment
Periodo de tiempo: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)

ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. Patients who cannot be assessed for response are counted as non-responders. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions.
From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)
Duration of Response (DOR) Per Central Radiographic Assessment
Periodo de tiempo: From randomization to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD (Up to approximately 74 months)

DOR is defined as the time from date of the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method.
From randomization to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD (Up to approximately 74 months)
Clinical Benefit Rate Per Central Radiographic Assessment
Periodo de tiempo: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)

CBR is defined as the percentage of patients documented to have a confirmed CR, confirmed PR, or SD, according to RECIST 1.1 as the best response. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)
Progression-Free Survival (PFS) Per Central Radiographic Assessment
Periodo de tiempo: From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 74 months)

PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Censoring was assigned on the date of the last tumor assessment if no assessment of tumor progression is identified and the patient does not die while on study. Patients with no evaluation of disease after first study treatment will have PFS censored on the date of randomization. Patients who start new anti-cancer therapy prior to documented PD will be censored at the date of the last tumor assessment prior to the start of the new therapy. Results obtained using Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method.
From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 74 months)
1-Year Survival Rate
Periodo de tiempo: At 12 months from first dose

1-Year Survival will be defined as the percentage of participants surviving at 1 year after the first dose. Results obtained via Kaplan-Meier estimation, Greenwood's formula (1980).
At 12 months from first dose
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score
Periodo de tiempo: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

The LCSS is a lung cancer specific measure of quality of life and includes 9 questions, including patient-reported ratings of six symptoms (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items (symptom distress, activity level, overall quality of life) using 100-mm visual analogue scales ranging from 0 (lowest rating) to 100 (highest rating) where a higher score represents a worse outcome. The average total score = is a sum of items 1 to 9 divided by the total number of items (sum of items 1 to 9) / 9).
Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI)
Periodo de tiempo: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.
Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS)
Periodo de tiempo: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points.
Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
Sitravatinib Plasma Concentration by Time Point
Periodo de tiempo: 0.5 hours post dose on cycle 1 (day 1) and 5 hours post dose on cycle 1 (day 1 and 15), and pre-dose on cycle 1 (day 15), and cycle 2, 3, and 5 (day 1)

Sitravatinib plasma concentration by time point. 1 cycle = 28 days.
0.5 hours post dose on cycle 1 (day 1) and 5 hours post dose on cycle 1 (day 1 and 15), and pre-dose on cycle 1 (day 15), and cycle 2, 3, and 5 (day 1)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mirati Therapeutics Inc.

Colaboradores

Bristol-Myers Squibb

Investigadores

  • Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb

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.

Enlaces Útiles

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)

15 de julio de 2019

Finalización primaria (Actual)

20 de marzo de 2023

Finalización del estudio (Actual)

30 de septiembre de 2025

Fechas de registro del estudio

Enviado por primera vez

4 de abril de 2019

Primero enviado que cumplió con los criterios de control de calidad

4 de abril de 2019

Publicado por primera vez (Actual)

8 de abril de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CA248-0001
  • 516-005 (Otro identificador: Mirati Therapeutics Protocol ID)
  • CA248-0001 (Otro identificador: Bristol-Myers Squibb Protocol ID)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir