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Vaiheen 3 tutkimus Sitravatinib Plus Nivolumab vs Docetaxel potilailla, joilla on pitkälle edennyt ei-levyepiteelinen ei-pienisoluinen keuhkosyöpä (SAPPHIRE)

keskiviikko 9. syyskuuta 2026 päivittänyt: Mirati Therapeutics Inc.

Satunnaistettu vaiheen 3 tutkimus Sitravatinibistä yhdistelmänä nivolumabin kanssa vs. dosetakseli potilailla, joilla on pitkälle edennyt ei-levyepiteelimäinen ei-pienisoluinen keuhkosyöpä, jonka sairaus on edennyt platinapohjaisen kemoterapian ja tarkistuspisteen estäjähoidon aikana tai sen jälkeen 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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

577

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Biologinen: Nivolumab

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

Muut nimet:
  • Opdivo
Lääke: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Muut nimet:
  • MGCD516
Active Comparator: Docetaxel

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

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

Muut nimet:
  • Taxotere

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Overall Survival (OS)
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Mirati Therapeutics Inc.

Yhteistyökumppanit

Bristol-Myers Squibb

Tutkijat

  • Opintojohtaja: Bristol-Myers Squibb, Bristol-Myers Squibb

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 15. heinäkuuta 2019

Ensisijainen valmistuminen (Todellinen)

Maanantai 20. maaliskuuta 2023

Opintojen valmistuminen (Todellinen)

Tiistai 30. syyskuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 4. huhtikuuta 2019

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 4. huhtikuuta 2019

Ensimmäinen Lähetetty (Todellinen)

Maanantai 8. huhtikuuta 2019

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 30. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 9. syyskuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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