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Phase-3-Studie zu Sitravatinib plus Nivolumab im Vergleich zu Docetaxel bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs ohne Plattenepithelkarzinom (SAPPHIRE)

9. September 2026 aktualisiert von: Mirati Therapeutics Inc.

Eine randomisierte Phase-3-Studie zu Sitravatinib in Kombination mit Nivolumab im Vergleich zu Docetaxel bei Patienten mit fortgeschrittenem, nicht-plattenepithelialem, nicht-kleinzelligem Lungenkrebs mit Krankheitsprogression während oder nach platinbasierter Chemotherapie und Checkpoint-Inhibitor-Therapie 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

577

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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:
  • Opdivo
Arzneimittel: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Andere Namen:
  • MGCD516
Aktiver Komparator: Docetaxel

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

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

Andere Namen:
  • Taxotere

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mirati Therapeutics Inc.

Mitarbeiter

Bristol-Myers Squibb

Ermittler

  • Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juli 2019

Primärer Abschluss (Tatsächlich)

20. März 2023

Studienabschluss (Tatsächlich)

30. September 2025

Studienanmeldedaten

Zuerst eingereicht

4. April 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. April 2019

Zuerst gepostet (Tatsächlich)

8. April 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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