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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

16 juni 2020 uppdaterad av: Bristol-Myers Squibb

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Studietyp

Interventionell

Inskrivning (Faktisk)

1289

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Cordoba, Argentina, X5006HBF
        • Local Institution
      • Cordoba, Argentina, X5006IKK
        • Local Institution
      • Mendoza, Argentina, M5500AYB
        • Local Institution
      • Santa Fe, Argentina, S3000FFU
        • Local Institution
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Local Institution
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000DSV
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution
  • Australien
    • South Australia
      • Bedford Park, South Australia, Australien, 5042
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    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Local Institution
      • Frankston, Victoria, Australien, 3199
        • Local Institution
      • Heidelberg, Victoria, Australien, 3084
        • Local Institution
      • Wodonga, Victoria, Australien, 3690
        • Local Institution
  • Belgien
      • Aalst, Belgien, 9300
        • Local Institution
      • Liege, Belgien, 4000
        • Local Institution
      • Sint Niklaas, Belgien, 9100
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      • Yvoir, Belgien, 5530
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  • Brasilien
      • Porto Alegre, Brasilien, 90430
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      • Ribeirao Preto, Brasilien, 14015
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      • Rio de Janeiro, Brasilien, 20231-050
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      • Sao Paulo, Brasilien, 01224-010
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      • Sao Paulo, Brasilien, 04039-901
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      • Fortaleza, Ceara, Brasilien, 60160-230
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      • Belo Horizonte, Minas Gerais, Brasilien, 30150-270
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    • Parana
      • Curitiba, Parana, Brasilien, 81520-060
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    • RIO Grande DO SUL
      • Passo Fundo, RIO Grande DO SUL, Brasilien, 99010260
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      • Sao Jose dos Campos, SAO Paulo, Brasilien, 12245
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    • Metropolitana
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      • Vina Del Mar, Valparaiso, Chile, 2540364
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    • Florida
      • Boca Raton, Florida, Förenta staterna, 33486
        • Lynn Cancer Institute Center For Hematology-Oncology
      • Jacksonville, Florida, Förenta staterna, 32256
        • Integrated Community Oncology Network
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612
        • University of Illinois at Chicago Medical Center
      • Quincy, Illinois, Förenta staterna, 62301
        • Quincy Medical Group
      • Skokie, Illinois, Förenta staterna, 60076
        • Presence Medical Group Hematology Oncology
      • Springfield, Illinois, Förenta staterna, 62794-9678
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46237
        • St. Francis Hospital & Health Centers
      • New Albany, Indiana, Förenta staterna, 47150
        • Floyd Memorial Cancer Center of Indiana
    • Kentucky
      • Hazard, Kentucky, Förenta staterna, 41701
        • Kentucky Cancer Clinic
      • Louisville, Kentucky, Förenta staterna, 40207
        • Norton Cancer Institute
      • Mount Sterling, Kentucky, Förenta staterna, 40353
        • Montgomery Cancer Center
    • Michigan
      • Ypsilanti, Michigan, Förenta staterna, 48197
        • St Joseph Mercy Hospital
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64131
        • University of Kansas Cancer Center
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Lake Success, New York, Förenta staterna, 11042
        • Clinical Research Alliance, Inc.
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Durham Va Medical Center (111g)
      • Huntersville, North Carolina, Förenta staterna, 28078
        • Carolina BioOncology Institute
      • Lexington, North Carolina, Förenta staterna, 27295
        • Novant Health Oncology Specialists
    • Ohio
      • Canton, Ohio, Förenta staterna, 44718
        • Gabrail Cancer Center Research
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74146
        • Oklahoma Oncology And Hematology, Pc Dba
    • Oregon
      • Portland, Oregon, Förenta staterna, 97227
        • Kaiser Permanente Northwest Region
    • Pennsylvania
      • Sayre, Pennsylvania, Förenta staterna, 18840
        • Guthrie Medical Group, P.C.
    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29209
        • WJB Dorn VA Medical Center
      • Greenville, South Carolina, Förenta staterna, 29615
        • Cancer Center Of The Carolinas
    • Tennessee
      • Chattanooga, Tennessee, Förenta staterna, 37421
        • Associated in Oncology and Hematology
      • Knoxville, Tennessee, Förenta staterna, 37909
        • Tennessee Cancer Specialists
      • Knoxville, Tennessee, Förenta staterna, 37916
        • Thompson Oncology Group
    • Texas
      • Austin, Texas, Förenta staterna, 78745
        • Texas Oncology, PA - South Austin Cancer Center
    • Virginia
      • Blacksburg, Virginia, Förenta staterna, 24060
        • Blue Ridge Cancer Care
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53705
        • Wisconsin Institutes for Medical Research
  • Hong Kong
      • Hong Kong, Hong Kong, 8525
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      • Treviglio, Italien, 24047
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  • Japan
      • Akashi, Hyogo, Japan, 6738558
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      • Fukuoka, Japan, 8128582
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      • Matsuyama, Ehime, Japan, 791-0280
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      • Sapporo Hokkaido, Japan, 003-080
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      • Takatsuki, Japan, 569-8686
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      • Tokyo, Japan, 135-8550
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    • Aichi
      • Nagoya, Aichi, Japan, 4648681
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      • Nagoya-shi, Aichi, Japan, 4600001
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    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
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    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
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    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japan, 2360051
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      • Yokohama-shi, Kanagawa, Japan, 2408555
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    • Miyagi
      • Natori-shi, Miyagi, Japan, 9811293
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      • Sendai, Miyagi, Japan, 9808574
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    • Okayama
      • Kurashiki-shi, Okayama, Japan, 7010192
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      • Kurashiki-shi, Okayama, Japan, 710-8602
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    • Osaka
      • Hirakata-shi, Osaka, Japan, 5731191
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    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
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    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
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    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7550241
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  • Kanada
      • Oshawa, Kanada, L1G 2B9
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    • Quebec
      • Montreal, Quebec, Kanada, H2W 1S6
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      • Montreal, Quebec, Kanada, H3T 1E2
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      • Montreal, Quebec, Kanada, H4J 1C5
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  • Kina
      • Beijing, Kina, 100032
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      • Beijing, Kina, 100071
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      • Beijing, Kina, 100142
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      • Beijing, Kina, 100853
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      • Santiago, Kina, 7630370
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      • Shanghai, Kina, 200030
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      • Shanghai, Kina, 200433
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    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
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      • Guanzhou, Guangdong, Kina, 510080
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      • Shantou, Guangdong, Kina, 515041
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    • Hubei
      • Wuhan, Hubei, Kina, 430023
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    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002
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      • Nanjing, Jiangsu, Kina, 210009
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      • Suzhou, Jiangsu, Kina, 215006
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    • Jilin
      • Changchun, Jilin, Kina, 130012
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    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710038
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    • Xinjiang
      • Urumqi, Xinjiang, Kina, 830011
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    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
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  • Korea, Republiken av
      • Busan, Korea, Republiken av, 602-739
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      • Daegu, Korea, Republiken av, 700-712
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      • Gyeonggi-do, Korea, Republiken av, 463-802
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      • Seoul, Korea, Republiken av, 110-744
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      • Cheonju-si, Chungcheongbuk-do, Korea, Republiken av, 361-771
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    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republiken av, 410-769
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      • Suwon-si, Gyeonggi-do, Korea, Republiken av, 442-723
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    • Kangnam-gu
      • Seoul, Kangnam-gu, Korea, Republiken av, 135-710
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    • Seodaemungu
      • Seoul, Seodaemungu, Korea, Republiken av, 120-752
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  • Mexiko
    • Distrito Federal
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  • Peru
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    • LA Libertad
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  • Polen
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Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Non small cell lung cancer (NSCLC) - squamous cell
  • Stage IV or recurrent NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ipilimumab + Paclitaxel and Carboplatin

Ipilimumab + Active Chemo Backbone

Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Läkemedel: Ipilimumab
Andra namn:
  • BMS-734016
Läkemedel: Karboplatin
Andra namn:
  • Paraplatin®
Läkemedel: Paklitaxel
Andra namn:
  • Taxol®
Placebo-jämförare: Placebo + Paclitaxel and Carboplatin

Placebo + Active Chemo Backbone

Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Läkemedel: Placebo
Läkemedel: Karboplatin
Andra namn:
  • Paraplatin®
Läkemedel: Paklitaxel
Andra namn:
  • Taxol®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Tidsram: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Tidsram: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Tidsram: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 januari 2011

Primärt slutförande (Faktisk)

9 juni 2015

Avslutad studie (Faktisk)

22 augusti 2017

Studieregistreringsdatum

Först inskickad

24 januari 2011

Först inskickad som uppfyllde QC-kriterierna

27 januari 2011

Första postat (Uppskatta)

28 januari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2020

Senast verifierad

1 juni 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CA184-104
  • 2009-017396-19 (EudraCT-nummer)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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