Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE)

October 20, 2023 updated by: Mirati Therapeutics Inc.

A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

532

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Antwerp
      • Brasschaat, Antwerp, Belgium, 2930
        • Algemeen Ziekenhuis Klina
    • East Flanders
      • Ronse, East Flanders, Belgium, 9600
        • Algemeen Ziekenhuis Glorieux Ronse
    • Henegouwen
      • Charleroi, Henegouwen, Belgium, 6000
        • Grand Hôpital De Charleroi - Notre Dame
    • Namur
      • Yvoir, Namur, Belgium, B-5530
        • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
    • Oost-Vlaaderen
      • Gent, Oost-Vlaaderen, Belgium, 9000
        • Algemeen ziekenhuis Maria Middelares
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Algemeen Ziekenhuis Delta
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
      • Saskatoon, Canada, S7N 4H4
        • Saskatoon Cancer Center
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Horizon Health Network - The Moncton Hospital
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Windsor, Ontario, Canada, N8W 3X3
        • Windsor Regional Hospital Cancer Program
  • France
      • Brest, France, 29200
        • Hopital Morvan
      • Bron, France, 69677
        • Hôpital Louis Pradel
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon Cedex, France, 21079
        • Centre Georges François Leclerc
      • Le Mans Cedex 9, France, 72037
        • Centre Hospitalier Le Mans
      • Limoges Cedex, France, 87042
        • Centre Hospitalier Universitaire Limoges
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Marseille cedex 20, France, 13915
        • Hopital Nord de Marseille
      • Montpellier, France, 34298
        • Institut Régional du Cancer de Montpellier - Val d'Aurelle
      • Paris Cedex 18, France, 75877
        • Hôpital Bichat-Claude-Bernard
      • Rouen, France, 76031
        • Rouen University Hôpital Charles-Nicolle
      • Saint-Herblain, France, 44800
        • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
      • Strasbourg, France, 67200
        • Institut de cancérologie Strasbourg Europe
      • Villejuif Cedex, France, 94802
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn
      • Essen, Germany, 45136
        • KEM. Evang.Kliniken Essen-Mitte gGmbh
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken München-Gauting
      • Halle, Germany, 06120
        • Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Köln, Germany, 51109
        • Kliniken der Stadt Köln
      • Lübeck, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein-Campus Lubeck
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik
      • München, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • München, Germany, 81925
        • München Klinik Bogenhausen
    • Baden-Württemberg
      • Heilbronn, Baden-Württemberg, Germany, 74078
        • Klinik Löwenstein gGmbH
    • Bayern
      • Immenstadt, Bayern, Germany, 87509
        • Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem - Pulmonológiai Klinika
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet
      • Törökbálint, Hungary, 2045
        • Torokbalinti Tudogyogyintezet
    • Gyor-Moson-Sopron
      • Győr, Gyor-Moson-Sopron, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Szent Borbala Korhaz
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Intézeti Gyógyszertár
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center
      • Be'er Sheva, Israel, 8410101
        • Soroka Medical Center
      • Be'er Ya'aqov, Israel, 7030000
        • Shamir Medical Center (Assaf Harofeh)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center
      • Safed, Israel, 1311001
        • ZIV Medical Center
      • Tel Aviv, Israel, 5822012
        • The Edith Wolfson Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
      • Bari, Italy, 70124
        • IRCCS Istituto Tumori "Giovanni Paolo II"
      • Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
      • Cremona, Italy, 26100
        • Ospedale di Cremona
      • Lecce, Italy, 73100
        • ASL Lecce - Ospedale Vito Fazzi
      • Monza, Italy, 20900
        • S.C Oncologia Medica, ASST Monza - Ospedale San Gerardo
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
      • Piacenza, Italy, 29121
        • Ospedale Guglielmo da Saliceto
      • Pisa, Italy, 56126
        • Azienda Ospedaliero - Universitaria Pisana
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Varese, Italy, 21100
        • ASST-SETTE LAGHI, Ospedale di Circolo e Fondazione Macchi
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo Di Oncologia
    • Naples
      • Napoli, Naples, Italy, 80100
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis - Breda Molengracht
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Groningen, Netherlands, 9700 RM
        • Martini Ziekenhuis
      • Nijmegen, Netherlands, 6525 GA
        • Radboud University Medical Center
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
        • The Netherlands Cancer Institute
    • North Brabant
      • s-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 BK
        • Isala
    • South Holland
      • Schiedam, South Holland, Netherlands, 3118 JH
        • Franciscus Vlietland & Gasthuis
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • Ziekenhuis Nieuwegein
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • Hagaziekenhuis Van Den Haag - Leyweg
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Spain
      • Barcelona, Spain, 08003.
        • Hospital del Mar - Parc de Salut Mar
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Las Palmas De Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
      • León, Spain, 24071
        • Hospital de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28006
        • Complejo Hospitalario Ruber Juan Bravo
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra - Madrid
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Díaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Oviedo, Spain, 15006
        • Hospital Universitario Central de Asturias
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Vigo, Spain, 36312
        • Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital Civil
  • Switzerland
      • Genève, Switzerland, CH - 1211
        • HUG: hopitaux universitaires de genève
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Winterthur, Switzerland, CH-8401
        • Kantonsspital Winterthur
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre University NHS Trust
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals Of Leicester Nhs Trust
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LI
        • Royal Cornwall Hospital NHS Trust
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • East and North Hertfordshire NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Alabama Oncology - Grandview
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Cancer Specialists - Glendale
      • Tucson, Arizona, United States, 85745
        • The Oncology Institute of Hope and Innovation - Tucson
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Fowler Family Center for Cancer Care
      • Jonesboro, Arkansas, United States, 72401
        • Saint Bernards Medical Center
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group - Springdale
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center - Bakersfield
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Corona, California, United States, 92882
        • The Oncology Institute of Hope and Innovation - Corona
      • Fullerton, California, United States, 92835
        • Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90017
        • Los Angeles Hematology Oncology Medical Group
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles - Jonsson Comprehensive Cancer Center
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Redlands, California, United States, 92373
        • Redlands Hematology Oncology
      • San Francisco, California, United States, 94518
        • University of California San Francisco
      • San Marcos, California, United States, 92069
        • California Cancer Associates for Research and Excellence - San Marcos
      • Thousand Oaks, California, United States, 91361
        • The Oncology Institute of Hope and Innovation - Thousand Oaks
      • Torrance, California, United States, 90505
        • Torrance Memorial Physician Network - Cancer Care and Infusion Center
      • West Covina, California, United States, 91790
        • Brian J. LeBerthon M.D.
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope and Innovation - Whittier
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Sisters of Charity of Leavenworth Health St. Mary's
      • Lafayette, Colorado, United States, 80026
        • Good Samaritan Medical Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists & Research Institute
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Cancer & Research Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Ocala, Florida, United States, 34474
        • Florida Cancer Affiliates - Ocala - Main
      • Orlando, Florida, United States, 32804
        • Cancer Institute of Florida - Orlando
      • Plantation, Florida, United States, 33322
        • BRCR Medical Center Inc
      • Sarasota, Florida, United States, 34232
        • SCRI - Florida Cancer Specialists - North Region Research Office
      • Tallahassee, Florida, United States, 32308
        • SCRI - Florida Cancer Specialists - Panhandle Research Office
      • West Palm Beach, Florida, United States, 33401
        • SCRI - Florida Cancer Specialists - West Palm Beach
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center - LLC - Athens
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center Research
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers - Marietta
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Straub Medical Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Beacon Cancer Care
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists - Niles
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research Inc.
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
      • Lafayette, Indiana, United States, 47904
        • Indiana University Health Arnett Cancer Care
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Commonwealth Cancer Center
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute - Broadway
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pontchartrain Cancer Center - Covington Office
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology - Rockville Aquilino Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet - Frauenshuh Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Kansas City, Missouri, United States, 64132
        • Kansas City Care Health Center - Research Medical Campus
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Hospital - Omaha
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group - Florham Park Campus
      • Little Silver, New Jersey, United States, 07739
        • Regional Cancer Care Associates - Little Silver
    • New York
      • Johnson City, New York, United States, 13790
        • Broome Oncology
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center
      • Port Jefferson Station, New York, United States, 11776
        • New York Cancer & Blood Specialists
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44708
        • Mercy Hematology & Oncology Associates
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care - Blue Ash
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Medicine
      • Massillon, Ohio, United States, 44646
        • Tricounty Hematology and Oncology- Massillon
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Clinic Oncology and Hematology - Coletta
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute Franz Clinic
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University Knight Cancer Institute
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center - Memphis
      • Nashville, Tennessee, United States, 37203
        • SCRI - Tennessee Oncology - Nashville - Centennial
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - South Austin
      • Beaumont, Texas, United States, 77702
        • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
      • Dallas, Texas, United States, 75203
        • Texas Oncology - Methodist Dallas Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Denton, Texas, United States, 76210
        • Texas Oncology - Denton South
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer & Blood Disorders - Fort Worth
      • Houston, Texas, United States, 77070
        • Texas Oncology - Houston Willowbrook
      • Houston, Texas, United States, 77090
        • Millennium Physicians - North Houston
      • McKinney, Texas, United States, 75071
        • Texas Oncology - McKinney
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology - Sugar Land
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute - Reynolds Crossing
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Center Partnership
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Spokane, Washington, United States, 99216
        • Cancer Care Northwest - North Spokane
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Madison, Wisconsin, United States, 53705
        • University Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital - Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Nivolumab
Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
Other Names:
  • Opdivo
Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Names:
  • MGCD516
Active Comparator: Docetaxel
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Drug: Docetaxel
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 36 Months
OS is defined as time from date of randomization to date of death due to any cause
36 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: 36 Months
Frequency of patients experiencing treatment-emergent AEs
36 Months
Objective Response Rate (ORR)
Time Frame: 36 Months
ORR defined as 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
36 Months
Progression-Free Survival (PFS)
Time Frame: 36 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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Ronald L. Shazer, MD, MBA, Mirati Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

March 20, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 516-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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