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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT03906071
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
  • Sitravatinib — DRUG
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
  • Docetaxel — DRUG
    Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Study Details

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.

Key Dates

Start date
Jul 15, 2019
Status verified
Oct 2025
Primary completion
Mar 20, 2023
Completion
Sep 30, 2025

Study Design

Enrollment
577 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization date to date of death due to any cause (Up to approximately 44 months) ]

Locations (133)

FacilityCityStateZIPSite coordinators
Local Institution - 005-164BirminghamAlabama35243-
Clearview Cancer Institute - HuntsvilleHuntsvilleAlabama35805-
Palo Verde Cancer Specialists - GlendaleGlendaleArizona85304-
The Oncology Institute of Hope & Innovation - TucsonTucsonArizona85745-
Yuma Regional Medical CenterYumaArizona85364-
Local Institution - 005-174JonesboroArkansas72401-
NEA Baptist Fowler Family Center for Cancer CareJonesboroArkansas72401-
Highlands Oncology Group - SpringdaleSpringdaleArkansas72762-
Comprehensive Blood and Cancer Center - BakersfieldBakersfieldCalifornia93309-
Local Institution - 005-118Beverly HillsCalifornia90211-
Local Institution - 005-171FresnoCalifornia93720-
Providence Medical Foundation - Virginia K. Crosson Cancer Center - FullertonFullertonCalifornia92835-
Local Institution - 005-096Long BeachCalifornia90813-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
Local Institution - 005-185Los AngelesCalifornia90095-
Los Angeles Hematology Oncology Medical GroupLos AngelesCalifornia90017-
Local Institution - 005-072Newport BeachCalifornia92663-
Local Institution - 005-109NorthridgeCalifornia91325-
Local Institution - 005-177RedlandsCalifornia92373-
Local Institution - 005-112RiversideCalifornia92501-
University of California San FranciscoSan FranciscoCalifornia94143-
Local Institution - 005-176San MarcosCalifornia92069-
Local Institution - 005-192TorranceCalifornia90505-
Local Institution - 005-090West CovinaCalifornia91790-
Local Institution - 005-105WhittierCalifornia90602-
Local Institution - 005-097LafayetteColorado80026-
Eastern Connecticut Hematology and Oncology AssociatesNorwichConnecticut06360-
Michael and Dianne Bienes Comprehensive Cancer CenterFort LauderdaleFlorida33308-
Local Institution - 005-120Fort MyersFlorida33901-
Memorial Regional HospitalHollywoodFlorida33021-
Watson Clinic Cancer and Research CenterLakelandFlorida33805-
Mount Sinai Health SystemMiami BeachFlorida33140-
Local Institution - 005-120ENaplesFlorida34102-
Local Institution - 005-079OcalaFlorida34474-
Local Institution - 005-104OrlandoFlorida32804-
SCRI - Florida Cancer Specialists - North Region Research OfficeSt. PetersburgFlorida33705-
SCRI - Florida Cancer Specialists - Panhandle Research OfficeTallahasseeFlorida32308-
Local Institution - 005-154West Palm BeachFlorida33401-
University Cancer & Blood Center (UCBC) - AthensAthensGeorgia30607-
Local Institution - 005-146AtlantaGeorgia30318-
John B. Amos Cancer Center ResearchColumbusGeorgia31904-
Local Institution - 005-119MariettaGeorgia30060-
Straub Medical CenterHonoluluHawaii96813-
Local Institution - 005-191Coeur d'AleneIdaho83814-
Local Institution - 005-151ChicagoIllinois60625-3645-
Local Institution - 005-110EvanstonIllinois60201-
Local Institution - 005-198NilesIllinois60714-
Orchard Healthcare ResearchSkokieIllinois60077-
Healthcare Research Network - Tinley ParkTinley ParkIllinois60487-
Fort Wayne Medical Oncology and Hematology - Fort Wayne South OfficeFort WayneIndiana46804-
Local Institution - 005-122GoshenIndiana46526-
Franciscan Health Cancer Center IndianapolisIndianapolisIndiana46237-
Local Institution - 005-150LafayetteIndiana47904-
Local Institution - 005-169WestwoodKansas66205-
Local Institution - 005-098WichitaKansas67214-
Commonwealth Cancer Center - FrankfortDanvilleKentucky40422-
Local Institution - 005-153LouisvilleKentucky40241-
New England Cancer Specialists - ScarboroughScarboroughMaine04074-
Local Institution - 005-178RockvilleMaryland20850-6535-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Henry Ford HospitalDetroitMichigan48202-
Local Institution - 005-127MinneapolisMinnesota55404-
Local Institution - 005-159Saint Louis ParkMinnesota55426-5000-
Jackson Oncology Associates - The Hederman Cancer CenterJacksonMississippi39202-
Central Care Cancer Center - BolivarBolivarMissouri65613-
Kansas City Care Health Center - Research Medical CampusKansas CityMissouri64132-
Sisters of Charity of Leavenworth Health St. MarysBillingsMontana59102-
Saint Francis Cancer Treatment CenterGrand IslandNebraska68803-
Methodist Hospital - OmahaOmahaNebraska68114-
Local Institution - 005-152HendersonNevada89074-
The Oncology Institute of Hope & Innovation - HendersonHendersonNevada89052-
Local Institution - 005-142Florham ParkNew Jersey07932-
Local Institution - 005-163Little SilverNew Jersey07739-
Cooperman Barnabas Medical CenterLivingstonNew Jersey07039-
Regional Cancer Care Associates - SpartaSpartaNew Jersey07871-
Local Institution - 005-123Johnson CityNew York13790-
Local Institution - 005-182Lake SuccessNew York11042-
New York Cancer & Blood Specialists - Port Jefferson Medical OncologyPort Jefferson StationNew York11776-
Local Institution - 005-107Stony BrookNew York11794-
Local Institution - 005-196CantonOhio44708-
USOR - Oncology Hematology Care - Blue AshCincinnatiOhio45242-
Local Institution - 005-181ColumbusOhio43210-
Tricounty Hematology and Oncology - MassillonMassillonOhio44646-
Local Institution - 005-103ToledoOhio43623-
Local Institution - 005-088Oklahoma CityOklahoma73120-
Local Institution - 005-073PortlandOregon97239-
Providence Portland Medical CenterPortlandOregon97213-
USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)HorshamPennsylvania19044-
Local Institution - 005-186PhiladelphiaPennsylvania19111-
Local Institution - 005-137ADicksonTennessee37055-
Local Institution - 005-137BDicksonTennessee37055-
Local Institution - 005-137CDicksonTennessee37055-
Local Institution - 005-137DDicksonTennessee37055-
Local Institution - 005-137EDicksonTennessee37055-
Local Institution - 005-137FDicksonTennessee37055-
Local Institution - 005-137GDicksonTennessee37055-
Local Institution - 005-137HDicksonTennessee37055-
Local Institution - 005-137IDicksonTennessee37055-
Local Institution - 005-137JDicksonTennessee37055-
Local Institution - 005-137KDicksonTennessee37055-
Local Institution - 005-137LDicksonTennessee37055-
Local Institution - 005-137MHendersonvilleTennessee37075-
Local Institution - 005-195MemphisTennessee38120-
Local Institution - 005-137NashvilleTennessee37203-
Local Institution - 005-134AustinTexas78745-
Local Institution - 005-075BeaumontTexas77702-
Local Institution - 005-126DallasTexas75246-
Local Institution - 005-128DallasTexas75203-
Local Institution - 005-129DallasTexas75231-
USOR - Texas Oncology Northeast Texas - DenisonDenisonTexas75020-
Local Institution - 005-124DentonTexas76201-
The Center for Cancer & Blood Disorders - Fort WorthFort WorthTexas76104-
Local Institution - 005-076HoustonTexas77070-
Millennium Research and Clinical DevelopmentHoustonTexas77090-
Oncology Consultants - Texas Medical CenterHoustonTexas77030-
USOR - US Oncology Investigational Products CenterIrvingTexas75063-
Local Institution - 005-125McKinneyTexas75071-
Texas Oncology - San Antonio Medical CenterSan AntonioTexas78240-
USOR - Texas Oncology - Sugar LandSugar LandTexas77479-
USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - TylerTylerTexas75702-
Local Institution - 005-144CharlottesvilleVirginia22903-
Hematology Oncology Associates of FredericksburgFredericksburgVirginia24408-
Virginia Cancer Institute - West EndRichmondVirginia23229-
Overlake Medical Center and ClinicsBellevueWashington98004-
Local Institution - 005-082EverettWashington98201-
Local Institution - 005-111SeattleWashington98109--1023-
Local Institution - 005-187SpokaneWashington99218-
Local Institution - 005-081TacomaWashington98405-
Northwest Medical Specialties - TacomaTacomaWashington98405-
Local Institution - 005-136VancouverWashington98684-
ThedaCare Regional Cancer CenterAppletonWisconsin54911-
Local Institution - 005-116MadisonWisconsin53792-
Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Local Institution - 005-164· Birmingham, ALClearview Cancer Institute - Huntsville· Huntsville, ALPalo Verde Cancer Specialists - Glendale· Glendale, AZThe Oncology Institute of Hope & Innovation - Tucson· Tucson, AZYuma Regional Medical Center· Yuma, AZLocal Institution - 005-174· Jonesboro, AR

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