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Fase 3-undersøgelse af Sitravatinib Plus Nivolumab vs. Docetaxel hos patienter med avanceret ikke-pladecellet ikke-småcellet lungekræft (SAPPHIRE)

9. september 2026 opdateret af: Mirati Therapeutics Inc.

Et randomiseret fase 3-studie af Sitravatinib i kombination med Nivolumab versus Docetaxel hos patienter med avanceret ikke-pladecellet ikke-småcellet lungekræft med sygdomsprogression på eller efter platinbaseret kemoterapi og checkpoint-hæmmerterapi 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

577

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 navne:
  • Opdivo
Medicin: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Andre navne:
  • MGCD516
Aktiv komparator: Docetaxel

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

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

Andre navne:
  • Taxotere

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mirati Therapeutics Inc.

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2019

Primær færdiggørelse (Faktiske)

20. marts 2023

Studieafslutning (Faktiske)

30. september 2025

Datoer for studieregistrering

Først indsendt

4. april 2019

Først indsendt, der opfyldte QC-kriterier

4. april 2019

Først opslået (Faktiske)

8. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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