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Fase 3-studie van sitravatinib plus nivolumab versus docetaxel bij patiënten met gevorderde niet-plaveiselcel niet-kleincellige longkanker (SAPPHIRE)

9 september 2026 bijgewerkt door: Mirati Therapeutics Inc.

Een gerandomiseerde fase 3-studie van sitravatinib in combinatie met nivolumab versus docetaxel bij patiënten met gevorderde niet-plaveiselcel niet-kleincellige longkanker met progressie van de ziekte tijdens of na op platina gebaseerde chemotherapie en checkpoint-remmertherapie 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

577

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: Nivolumab

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

Andere namen:
  • Optie
Geneesmiddel: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Andere namen:
  • MGCD516
Actieve vergelijker: Docetaxel

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

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

Andere namen:
  • Taxoter

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mirati Therapeutics Inc.

Medewerkers

Bristol-Myers Squibb

Onderzoekers

  • Studie directeur: Bristol-Myers Squibb, Bristol-Myers Squibb

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juli 2019

Primaire voltooiing (Werkelijk)

20 maart 2023

Studie voltooiing (Werkelijk)

30 september 2025

Studieregistratiedata

Eerst ingediend

4 april 2019

Eerst ingediend dat voldeed aan de QC-criteria

4 april 2019

Eerst geplaatst (Werkelijk)

8 april 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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