A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02574078
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
  • Bevacizumab — DRUG
  • Pemetrexed — DRUG
  • Best Supportive Care — OTHER
    Palliative radiation, palliative surgery and/or other best supportive care treatments
  • nab-Paclitaxel — DRUG
  • Paclitaxel — DRUG
  • Docetaxel — DRUG
  • Gemcitabine — DRUG
  • Erlotinib — DRUG
  • Crizotinib — DRUG
  • Carboplatin — DRUG

Study Details

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Key Dates

Start date
Nov 23, 2015
Status verified
Apr 2021
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020

Study Design

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

Arms

  • Experimental: Group A Nivolumab
    Opdivo specified dose on specified days
  • Experimental: Group A Nivolumab + SOC maintenance therapy
    Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days
  • Active Comparator: Group A SOC maintenance therapy
    Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days
  • Experimental: Group B Nivolumab
    Opdivo specified dose on specified days
  • Other: Group B Best supportive care
    Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
  • Active Comparator: Group C Investigator's choice chemotherapy
    Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days
  • Experimental: Group C Nivolumb
    Opdivo specified dose on specified days
  • Active Comparator: Group D Erlotinib
    Erlotinib specified dose on specified days
  • Experimental: Group D Nivolumab + Erlotinib
    Opdivo/Erlotnib specified dose on specified days
  • Experimental: Group E Nivolumab + Crizotinib
    Opdivo/Crizotinib specified dose on specified days

Primary Outcome Measure

Progression-Free Survival (PFS), Groups A-D Only [ Time Frame: up to approximately 48 months ]

Locations (133)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama35205-
Southern Cancer Center PcMobileAlabama36608-
Arizona Oncology Assoc, Pc-HalGlendaleArizona85308-
Northern Arizona Hematology & Oncology AssociatesSedonaArizona86336-
Arizona Clinical Research Center, Inc.TucsonArizona85715-
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) HopeTucsonArizona85704-
Comprehensive Blood And Cancer CenterBakersfieldCalifornia93309-
St. Joseph Heritage Medical GroupFullertonCalifornia92835-
Scripps Cancer CenterLa JollaCalifornia92037-
UCLA Hematology/Oncology ClinicLos AngelesCalifornia90095-
Coastal Integrative Cancer CareSan Luis ObispoCalifornia93401-
Central Coast Med OncologySanta MariaCalifornia93454-
Local InstitutionSolvangCalifornia93463-
St. Mary's Hospital Regional Cancer CenterGrand JunctionColorado81501-
Rocky Mountain Cancer CentersLakewoodColorado80228-
Eastern Ct Hem Onc AssocNorwichConnecticut06360-
Stamford HospitalStamfordConnecticut06904-
Va Ct Healthcare SystemWest HavenConnecticut06516-
Florida Cancer Specialists S.Fort MyersFlorida33901-
University of Florida at ShandsGainesvilleFlorida32610-
Memorial Cancer InstituteHollywoodFlorida33201-
Baptist Health Medical Group OncologyMiamiFlorida33176-
Ocala Oncology CenterOcalaFlorida34471-
Hematology Oncology Associates Of The Treasure CoastPort Saint LucieFlorida34952-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Tallahassee Memorial Cancer CenterTallahasseeFlorida32308-
Florida Cancer AffiliatesTrinityFlorida34655-
University Cancer Blood CtrAthensGeorgia30607-
Cancer Treatment Centers Of AmericaNewnanGeorgia30265-
Summit Cancer CareSavannahGeorgia31405-
Lewis Hall Singletary Oncology CenterThomasvilleGeorgia31792-
Illinois Cancer SpecialistsNilesIllinois60714-
Community Clinical Research CenterAndersonIndiana46011-
Ft. Wayne Med Onco-Hema IncFort WayneIndiana46845-
Cotton-O-Neil Clinical Research CenterTopekaKansas66606-
West KY Hematology Oncology Group PSCPaducahKentucky42003-
Christus St. Francis Cabrini Cancer CenterAlexandriaLouisiana71301-
East Jefferson General HospitalMetairieLouisiana70006-
New England Cancer SpecialistsScarboroughMaine04074-
Anne Arundel Medical CenterAnnapolisMaryland21401-
Sinai Hospital Of BaltimoreBaltimoreMaryland21215-
University Of MarylandBaltimoreMaryland21201-
Center For Cancer And Blood DisordersBethesdaMaryland20817-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Bay Hematology OncologyEastonMaryland21601-
Cancer & Hematology Centers Of Western MichiganGrand RapidsMichigan49503-
Minnesota Oncology Hematology, P.A.EdinaMinnesota55435-
Forrest General Cancer CenterHattiesburgMississippi39401-
Jackson Oncology Associates, PllcJacksonMississippi39202-
St. Louis Cancer Care, LlpBridgetonMissouri63044-
Saint Vincent Frontier Cancer CenterBillingsMontana59105-
Southeast Nebraska Cancer CenterLincolnNebraska68510-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
Hunterdon Medical CenterFlemingtonNew Jersey08822-
Summit Medical GroupMorristownNew Jersey07960-
Atlantic Health SystemSummitNew Jersey07901-
Morristown Medical CenterSummitNew Jersey07901-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
New York Oncology Hematology, PcAlbanyNew York12208-
Glens Falls HospitalGlens FallsNew York12801-
Broome OncologyJohnson CityNew York13790-
Northern Westchester HospitalMount KiscoNew York10549-
Columbia University Medical Center (Cumc)New YorkNew York10032-
Hematology-Oncology Associates Of RocklandNyackNew York10960-
White Plains HospitalWhite PlainsNew York10601-
Cone Health Cancer CenterGreensboroNorth Carolina27403-
Moses Cone Health SystemGreensboroNorth Carolina27403-
Randolph Cancer CenterGreensboroNorth Carolina27403-
First Health Of The CarolinasPinehurstNorth Carolina28374-
W.G. Bill Hefner VA Medical CenterSalisburyNorth Carolina28144-
Cancer Care CenterBismarckNorth Dakota58501-
Sanford HealthFargoNorth Dakota58122-
Oncology Hematology Care, Inc.CincinnatiOhio45242-
Louis Stokes Cleveland VA Medical CenterClevelandOhio44106-1702-
MetroHealth Medical CenterClevelandOhio44109-
Mid Ohio Oncology HematologyColumbusOhio43219-
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical ResearchTulsaOklahoma74146-
Oncology Associates Of Oregon, PcEugeneOregon97401-
Hematology Oncology AssociatesMedfordOregon97504-
Lehigh Valley HospitalAllentownPennsylvania18103-
St. Luke's University Hospital BethlehemBethlehemPennsylvania18015-
Erie Regional Cancer CenterEriePennsylvania16505-
Abington Hematology Oncology Associates, IncHorshamPennsylvania18944-
Charleston Hematology Oncology Associates, PaCharlestonSouth Carolina29414-
Greenville Health SystemGreenvilleSouth Carolina29615-
Sanford ResearchSioux FallsSouth Dakota57104-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
The Jones Clinic, PCGermantownTennessee38138-
West Cancer CenterGermantownTennessee38138-
Tennessee Oncology, PLLC - SCRI - PPDSNashvilleTennessee37203-
Texas Oncology-AbileneAbileneTexas79606-
Texas Oncology - AmarilloAmarilloTexas79106-
Texas Oncology-Arlington NorthArlingtonTexas76012-
Texas Oncology-Central Austin Cancer CenterAustinTexas78745-
Texas Oncology-BeaumontBeaumontTexas77702-
Texas OncologyBedfordTexas76022-
Texas OncologyDallasTexas75230-
Texas OncologyDallasTexas75231-
Texas Oncology, P.A.DallasTexas75246-
Texas Oncology/Methodist Charlton Cancer CtrDallasTexas75203-
Texas OncologyDentonTexas76201-
Texas OncologyEl PasoTexas79902-
Texas OncologyFlower MoundTexas75028-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
Texas OncologyFort WorthTexas76104-
The Center For Cancer And Blood DisordersFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Texas OncologyHoustonTexas77024-
Texas Cancer Center Of MesquiteMesquiteTexas75150-
Texas Oncology, PaMidlandTexas79701-
Texas OncologyNew BraunfelsTexas78130-
Texas OncologyParisTexas75460-
Texas Oncology Plano West Cancer CenterPlanoTexas75093-
Texas Oncology-Plano EastPlanoTexas75075-7787-
Cancer Centers of South TexasSan AntonioTexas78212-
Texas Cancer Center - ShermanShermanTexas75090-
Texas Oncology Cancer Center - Sugar LandSugar LandTexas77479-
Texas Oncology-TylerTylerTexas75702-
Texas Oncology Cancer Care And Research CenterWacoTexas76712-
Texas Oncology, P.A.WebsterTexas77598-4420-
Texas OncologyWeslacoTexas78596-
Texas Oncology-Wichita FallsWichita FallsTexas76310-
Oncology & Hematology Associates Of Southwest Virginia, Inc.BlacksburgVirginia24060-
Virginia Cancer Specialists, PcFairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-
Virginia Cancer InstituteRichmondVirginia23230-
Shenandoah OncologyWinchesterVirginia22601-
Providence Regional Cancer PartnershipEverettWashington98201-
Cancer Care NorthwestSpokane ValleyWashington99216-
Northwest Cancer Specialists, PcVancouverWashington98684-
Yakima Valley Memorial Hospital/North Star LodgeYakimaWashington98902-
Edwards Comprehensive Cancer CenterHuntingtonWest Virginia25701-

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