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진행성 비편평 비소세포폐암 환자를 대상으로 한 Sitravatinib + Nivolumab vs Docetaxel의 3상 연구 (SAPPHIRE)

2026년 9월 9일 업데이트: Mirati Therapeutics Inc.

백금 기반 화학요법 및 관문 억제제 요법 중 또는 이후에 질병이 진행된 진행성 비편평 비소세포폐암 환자를 대상으로 니볼루맙과 도세탁셀을 병용한 시트라바티닙의 무작위 3상 연구 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

577

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: Nivolumab

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

다른 이름들:
  • 옵디보
의약품: Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

다른 이름들:
  • MGCD516
활성 비교기: Docetaxel

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

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

다른 이름들:
  • 탁소테레

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Mirati Therapeutics Inc.

협력자

Bristol-Myers Squibb

수사관

  • 연구 책임자: Bristol-Myers Squibb, Bristol-Myers Squibb

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 7월 15일

기본 완료 (실제)

2023년 3월 20일

연구 완료 (실제)

2025년 9월 30일

연구 등록 날짜

최초 제출

2019년 4월 4일

QC 기준을 충족하는 최초 제출

2019년 4월 4일

처음 게시됨 (실제)

2019년 4월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다