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Fase 3-studie av Sitravatinib Plus Nivolumab vs. Docetaxel hos pasienter med avansert ikke-plateepitel, ikke-småcellet lungekreft (SAPPHIRE)

9. september 2026 oppdatert av: Mirati Therapeutics Inc.

En randomisert fase 3-studie av Sitravatinib i kombinasjon med Nivolumab versus Docetaxel hos pasienter med avansert ikke-plateepitel, ikke-småcellet lungekreft med sykdomsprogresjon på eller etter platinabasert kjemoterapi og sjekkpunkthemmerterapi 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

577

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: Nivolumab

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

Andre navn:
  • Opdivo
Legemiddel: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Andre navn:
  • MGCD516
Aktiv komparator: Docetaxel

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

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

Andre navn:
  • Taxotere

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mirati Therapeutics Inc.

Samarbeidspartnere

Bristol-Myers Squibb

Etterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2019

Primær fullføring (Faktiske)

20. mars 2023

Studiet fullført (Faktiske)

30. september 2025

Datoer for studieregistrering

Først innsendt

4. april 2019

Først innsendt som oppfylte QC-kriteriene

4. april 2019

Først lagt ut (Faktiske)

8. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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