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Badanie fazy 3 Sitravatinib Plus Nivolumab vs Docetaxel u pacjentów z zaawansowanym niepłaskonabłonkowym niedrobnokomórkowym rakiem płuca (SAPPHIRE)

9 września 2026 zaktualizowane przez: Mirati Therapeutics Inc.

Randomizowane badanie III fazy dotyczące stosowania sitwatynibu w skojarzeniu z niwolumabem w porównaniu z docetakselem u pacjentów z zaawansowanym niepłaskonabłonkowym niedrobnokomórkowym rakiem płuca z progresją choroby w trakcie lub po chemioterapii opartej na platynie i terapii inhibitorami punktów kontrolnych 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

577

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Biologiczny: Nivolumab

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

Inne nazwy:
  • Opdivo
Lek: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Inne nazwy:
  • MGCD516
Aktywny komparator: Docetaxel

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

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

Inne nazwy:
  • Taxotere

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Mirati Therapeutics Inc.

Współpracownicy

Bristol-Myers Squibb

Śledczy

  • Dyrektor Studium: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 lipca 2019

Zakończenie podstawowe (Rzeczywisty)

20 marca 2023

Ukończenie studiów (Rzeczywisty)

30 września 2025

Daty rejestracji na studia

Pierwszy przesłany

4 kwietnia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 kwietnia 2019

Pierwszy wysłany (Rzeczywisty)

8 kwietnia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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