Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT03906071
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
577 participants
INTERVENTIONAL
2019-07-15
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Nivolumab
Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Docetaxel
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Docetaxel
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Interventions
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Nivolumab
Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Docetaxel
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 005-164
Birmingham, Alabama, United States
Clearview Cancer Institute - Huntsville
Huntsville, Alabama, United States
Palo Verde Cancer Specialists - Glendale
Glendale, Arizona, United States
The Oncology Institute of Hope & Innovation - Tucson
Tucson, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
Local Institution - 005-174
Jonesboro, Arkansas, United States
NEA Baptist Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States
Comprehensive Blood and Cancer Center - Bakersfield
Bakersfield, California, United States
Local Institution - 005-118
Beverly Hills, California, United States
Local Institution - 005-171
Fresno, California, United States
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
Fullerton, California, United States
Local Institution - 005-096
Long Beach, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
Local Institution - 005-185
Los Angeles, California, United States
Local Institution - 005-072
Newport Beach, California, United States
Local Institution - 005-109
Northridge, California, United States
Local Institution - 005-177
Redlands, California, United States
Local Institution - 005-112
Riverside, California, United States
University of California San Francisco
San Francisco, California, United States
Local Institution - 005-176
San Marcos, California, United States
Local Institution - 005-192
Torrance, California, United States
Local Institution - 005-090
West Covina, California, United States
Local Institution - 005-105
Whittier, California, United States
Local Institution - 005-097
Lafayette, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, United States
Local Institution - 005-120
Fort Myers, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Watson Clinic Cancer and Research Center
Lakeland, Florida, United States
Mount Sinai Health System
Miami Beach, Florida, United States
Local Institution - 005-120E
Naples, Florida, United States
Local Institution - 005-079
Ocala, Florida, United States
Local Institution - 005-104
Orlando, Florida, United States
SCRI - Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, United States
SCRI - Florida Cancer Specialists - Panhandle Research Office
Tallahassee, Florida, United States
Local Institution - 005-154
West Palm Beach, Florida, United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States
Local Institution - 005-146
Atlanta, Georgia, United States
John B. Amos Cancer Center Research
Columbus, Georgia, United States
Local Institution - 005-119
Marietta, Georgia, United States
Straub Medical Center
Honolulu, Hawaii, United States
Local Institution - 005-191
Coeur d'Alene, Idaho, United States
Local Institution - 005-151
Chicago, Illinois, United States
Local Institution - 005-110
Evanston, Illinois, United States
Local Institution - 005-198
Niles, Illinois, United States
Orchard Healthcare Research
Skokie, Illinois, United States
Healthcare Research Network - Tinley Park
Tinley Park, Illinois, United States
Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office
Fort Wayne, Indiana, United States
Local Institution - 005-122
Goshen, Indiana, United States
Franciscan Health Cancer Center Indianapolis
Indianapolis, Indiana, United States
Local Institution - 005-150
Lafayette, Indiana, United States
Local Institution - 005-169
Westwood, Kansas, United States
Local Institution - 005-098
Wichita, Kansas, United States
Commonwealth Cancer Center - Frankfort
Danville, Kentucky, United States
Local Institution - 005-153
Louisville, Kentucky, United States
New England Cancer Specialists - Scarborough
Scarborough, Maine, United States
Local Institution - 005-178
Rockville, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Local Institution - 005-127
Minneapolis, Minnesota, United States
Local Institution - 005-159
Saint Louis Park, Minnesota, United States
Jackson Oncology Associates - The Hederman Cancer Center
Jackson, Mississippi, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Kansas City Care Health Center - Research Medical Campus
Kansas City, Missouri, United States
Sisters of Charity of Leavenworth Health St. Marys
Billings, Montana, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Methodist Hospital - Omaha
Omaha, Nebraska, United States
The Oncology Institute of Hope & Innovation - Henderson
Henderson, Nevada, United States
Local Institution - 005-152
Henderson, Nevada, United States
Local Institution - 005-142
Florham Park, New Jersey, United States
Local Institution - 005-163
Little Silver, New Jersey, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Regional Cancer Care Associates - Sparta
Sparta, New Jersey, United States
Local Institution - 005-123
Johnson City, New York, United States
Local Institution - 005-182
Lake Success, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
Port Jefferson Station, New York, United States
Local Institution - 005-107
Stony Brook, New York, United States
Local Institution - 005-196
Canton, Ohio, United States
USOR - Oncology Hematology Care - Blue Ash
Cincinnati, Ohio, United States
Local Institution - 005-181
Columbus, Ohio, United States
Tricounty Hematology and Oncology - Massillon
Massillon, Ohio, United States
Local Institution - 005-103
Toledo, Ohio, United States
Local Institution - 005-088
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Local Institution - 005-073
Portland, Oregon, United States
USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)
Horsham, Pennsylvania, United States
Local Institution - 005-186
Philadelphia, Pennsylvania, United States
Local Institution - 005-137A
Dickson, Tennessee, United States
Local Institution - 005-137B
Dickson, Tennessee, United States
Local Institution - 005-137C
Dickson, Tennessee, United States
Local Institution - 005-137D
Dickson, Tennessee, United States
Local Institution - 005-137E
Dickson, Tennessee, United States
Local Institution - 005-137F
Dickson, Tennessee, United States
Local Institution - 005-137G
Dickson, Tennessee, United States
Local Institution - 005-137H
Dickson, Tennessee, United States
Local Institution - 005-137I
Dickson, Tennessee, United States
Local Institution - 005-137J
Dickson, Tennessee, United States
Local Institution - 005-137K
Dickson, Tennessee, United States
Local Institution - 005-137L
Dickson, Tennessee, United States
Local Institution - 005-137M
Hendersonville, Tennessee, United States
Local Institution - 005-195
Memphis, Tennessee, United States
Local Institution - 005-137
Nashville, Tennessee, United States
Local Institution - 005-134
Austin, Texas, United States
Local Institution - 005-075
Beaumont, Texas, United States
Local Institution - 005-128
Dallas, Texas, United States
Local Institution - 005-129
Dallas, Texas, United States
Local Institution - 005-126
Dallas, Texas, United States
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas, United States
Local Institution - 005-124
Denton, Texas, United States
The Center for Cancer & Blood Disorders - Fort Worth
Fort Worth, Texas, United States
Oncology Consultants - Texas Medical Center
Houston, Texas, United States
Local Institution - 005-076
Houston, Texas, United States
Millennium Research and Clinical Development
Houston, Texas, United States
USOR - US Oncology Investigational Products Center
Irving, Texas, United States
Local Institution - 005-125
McKinney, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
USOR - Texas Oncology - Sugar Land
Sugar Land, Texas, United States
USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler
Tyler, Texas, United States
Local Institution - 005-144
Charlottesville, Virginia, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Virginia Cancer Institute - West End
Richmond, Virginia, United States
Overlake Medical Center and Clinics
Bellevue, Washington, United States
Local Institution - 005-082
Everett, Washington, United States
Local Institution - 005-111
Seattle, Washington, United States
Local Institution - 005-187
Spokane, Washington, United States
Local Institution - 005-081
Tacoma, Washington, United States
Northwest Medical Specialties - Tacoma
Tacoma, Washington, United States
Local Institution - 005-136
Vancouver, Washington, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Local Institution - 005-116
Madison, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Local Institution - 005-201
Brasschaat, , Belgium
Local Institution - 005-200
Charleroi, , Belgium
Local Institution - 005-206
Edegem, , Belgium
Local Institution - 005-202
Ghent, , Belgium
Local Institution - 005-207
Ghent, , Belgium
Local Institution - 005-205
Roeselare, , Belgium
Local Institution - 005-204
Ronse, , Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
Yvoir, , Belgium
Local Institution - 005-259
Calgary, Alberta, Canada
Local Institution - 005-250
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Local Institution - 005-252
Hamilton, Ontario, Canada
Local Institution - 005-251
Toronto, Ontario, Canada
Local Institution - 005-257
Windsor, Ontario, Canada
Local Institution - 005-255
Montreal, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Local Institution - 005-258
Québec, , Canada
Local Institution - 005-307
Brest, , France
Local Institution - 005-310
Bron, , France
Local Institution - 005-311
Créteil, , France
Local Institution - 005-303
Dijon, , France
Local Institution - 005-309
Le Mans, , France
Local Institution - 005-308
Limoges, , France
Local Institution - 005-317
Lyon, , France
Local Institution - 005-301
Marseille, , France
Local Institution - 005-312
Marseille, , France
Local Institution - 005-313
Montpellier, , France
Local Institution - 005-306
Mulhouse, , France
Local Institution - 005-302
Paris, , France
Local Institution - 005-314
Rouen, , France
Local Institution - 005-316
Saint-Herblain, , France
Local Institution - 005-305
Strasbourg, , France
Local Institution - 005-304
Villejuif, , France
Local Institution - 005-400
Bad Berka, , Germany
Local Institution - 005-418
Berlin, , Germany
Local Institution - 005-401
Bonn, , Germany
Local Institution - 005-412
Cologne, , Germany
Local Institution - 005-419
Essen, , Germany
Local Institution - 005-406
Esslingen am Neckar, , Germany
Local Institution - 005-403
Gauting, , Germany
Local Institution - 005-417
Grohansdorf, , Germany
Local Institution - 005-408
Halle, , Germany
Local Institution - 005-411
Immenstadt im Allgäu, , Germany
Local Institution - 005-416
Kassel, , Germany
Local Institution - 005-410
Löwenstein, , Germany
Local Institution - 005-405
Lübeck, , Germany
Local Institution - 005-414
Mainz, , Germany
Local Institution - 005-413
München, , Germany
Local Institution - 005-402
München, , Germany
Local Institution - 005-454
Budapest, , Hungary
Local Institution - 005-457
Budapest, , Hungary
Local Institution - 005-455
Budapest, , Hungary
Local Institution - 005-453
Farkasgyepű, , Hungary
Local Institution - 005-452
Győr, , Hungary
Local Institution - 005-451
Szombathely, , Hungary
Local Institution - 005-450
Tatabánya, , Hungary
Local Institution - 005-456
Törökbálint, , Hungary
Local Institution - 005-500
Afula, , Israel
Local Institution - 005-501
Beer Yaakov, , Israel
Local Institution - 005-504
Beersheba, , Israel
Local Institution - 005-502
Holon, , Israel
Local Institution - 005-507
Jerusalem, , Israel
Local Institution - 005-506
Ramat Gan, , Israel
Local Institution - 005-505
Zsfat, , Israel
Local Institution - 005-612
Alessandria, , Italy
Local Institution - 005-602
Bari, , Italy
Local Institution - 005-603
Catania, , Italy
Local Institution - 005-611
Cremona, , Italy
Local Institution - 005-608
Lecce, , Italy
Local Institution - 005-610
Meldola, , Italy
Local Institution - 005-606
Milan, , Italy
Local Institution - 005-605
Monza, , Italy
Local Institution - 005-604
Napoli, , Italy
Local Institution - 005-600
Parma, , Italy
Local Institution - 005-607
Piacenza, , Italy
Local Institution - 005-609
Pisa, , Italy
Local Institution - 005-614
Roma, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Local Institution - 005-700
's-Hertogenbosch, , Netherlands
Local Institution - 005-703
Amsterdam, , Netherlands
Local Institution - 005-711
Amsterdam, , Netherlands
Local Institution - 005-707
Breda, , Netherlands
Local Institution - 005-713
Dordrecht, , Netherlands
Local Institution - 005-702
Groningen, , Netherlands
Local Institution - 005-712
Maastricht, , Netherlands
Local Institution - 005-714
Nijmegen, , Netherlands
Local Institution - 005-710
Rotterdam, , Netherlands
Local Institution - 005-705
Rotterdam, , Netherlands
Local Institution - 005-709
The Hague, , Netherlands
Local Institution - 005-701
Utrecht, , Netherlands
Local Institution - 005-708
Utrecht, , Netherlands
Local Institution - 005-706
Zwolle, , Netherlands
Local Institution - 005-807
A Coruña, , Spain
Local Institution - 005-800
Badalona, , Spain
Local Institution - 005-822
Barcelona, , Spain
Local Institution - 005-811
Barcelona, , Spain
Local Institution - 005-810
Barcelona, , Spain
Local Institution - 005-805
Jaén, , Spain
Local Institution - 005-816
Las Palmas de Gran Canaria, , Spain
Local Institution - 005-817
León, , Spain
Local Institution - 005-812
Lugo, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Local Institution - 005-808
Madrid, , Spain
Local Institution - 005-819
Madrid, , Spain
Local Institution - 005-821
Madrid, , Spain
Local Institution - 005-813
Madrid, , Spain
Local Institution - 005-815
Madrid, , Spain
Local Institution - 005-809
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Local Institution - 005-806
Majadahonda, , Spain
Local Institution - 005-801
Málaga, , Spain
Local Institution - 005-803
Oviedo, , Spain
Local Institution - 005-823
Santiago de Compostela, , Spain
IVO - Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Local Institution - 005-804
Valencia, , Spain
Local Institution - 005-818
Vigo, , Spain
Inselspital Universitatsspital Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Velindre University NHS Trust
Cardiff, , United Kingdom
Local Institution - 005-904
Cornwall, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Local Institution - 005-908
London, , United Kingdom
Local Institution - 005-900
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Local Institution - 005-903
Middlesex, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA248-0001
Identifier Type: OTHER
Identifier Source: secondary_id
516-005
Identifier Type: OTHER
Identifier Source: secondary_id
CA248-0001
Identifier Type: -
Identifier Source: org_study_id
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