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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1289

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
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      • Frankston, Victoria, Australien, 3199
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      • Heidelberg, Victoria, Australien, 3084
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      • Wodonga, Victoria, Australien, 3690
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  • Belgien
      • Aalst, Belgien, 9300
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      • Liege, Belgien, 4000
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      • Sint Niklaas, Belgien, 9100
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      • Yvoir, Belgien, 5530
        • Local Institution
  • Brasilien
      • Porto Alegre, Brasilien, 90430
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      • Ribeirao Preto, Brasilien, 14015
        • Local Institution
      • 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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      • Belo Horizonte, Minas Gerais, Brasilien, 30150-270
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      • Curitiba, Parana, Brasilien, 81520-060
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      • Passo Fundo, RIO Grande DO SUL, Brasilien, 99010260
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      • Barretos, SAO Paulo, Brasilien, 14784
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      • Sao Jose dos Campos, SAO Paulo, Brasilien, 12245
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  • Canada
      • Oshawa, Canada, L1G 2B9
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    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
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      • Montreal, Quebec, Canada, H3T 1E2
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      • Montreal, Quebec, Canada, H4J 1C5
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  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7520378
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      • Santiago, Metropolitana, Chile, 8380455
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    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540364
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  • Colombia
    • Cordoba
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    • Risaralda
      • Pereira, Risaralda, Colombia
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  • Danmark
      • Aalborg, Danmark, 9000
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      • Herlev, Danmark, 2730
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  • Den Russiske Føderation
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      • Kazan, Den Russiske Føderation, 420029
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      • Moscow, Den Russiske Føderation, 115478
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      • St-Peterburg, Den Russiske Føderation, 198255
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      • Tula, Den Russiske Føderation, 300053
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  • Det Forenede Kongerige
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      • Dundee, Angus/forfarshire, Det Forenede Kongerige, DD1 9SY
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    • Cornwall
      • Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
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    • Hampshire
      • Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
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  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92123
        • Sharp Memorial Hospital
    • Connecticut
      • West Haven, Connecticut, Forenede Stater, 06516
        • VA Connecticut Healthcare System
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Lynn Cancer Institute Center For Hematology-Oncology
      • Jacksonville, Florida, Forenede Stater, 32256
        • Integrated Community Oncology Network
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago Medical Center
      • Quincy, Illinois, Forenede Stater, 62301
        • Quincy Medical Group
      • Skokie, Illinois, Forenede Stater, 60076
        • Presence Medical Group Hematology Oncology
      • Springfield, Illinois, Forenede Stater, 62794-9678
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46237
        • St. Francis Hospital & Health Centers
      • New Albany, Indiana, Forenede Stater, 47150
        • Floyd Memorial Cancer Center of Indiana
    • Kentucky
      • Hazard, Kentucky, Forenede Stater, 41701
        • Kentucky Cancer Clinic
      • Louisville, Kentucky, Forenede Stater, 40207
        • Norton Cancer Institute
      • Mount Sterling, Kentucky, Forenede Stater, 40353
        • Montgomery Cancer Center
    • Michigan
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • St Joseph Mercy Hospital
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • University of Kansas Cancer Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Lake Success, New York, Forenede Stater, 11042
        • Clinical Research Alliance, Inc.
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Durham Va Medical Center (111g)
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Carolina BioOncology Institute
      • Lexington, North Carolina, Forenede Stater, 27295
        • Novant Health Oncology Specialists
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Gabrail Cancer Center Research
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Oklahoma Oncology And Hematology, Pc Dba
    • Oregon
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente Northwest Region
    • Pennsylvania
      • Sayre, Pennsylvania, Forenede Stater, 18840
        • Guthrie Medical Group, P.C.
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29209
        • WJB Dorn VA Medical Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • Cancer Center Of The Carolinas
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • Associated in Oncology and Hematology
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Tennessee Cancer Specialists
      • Knoxville, Tennessee, Forenede Stater, 37916
        • Thompson Oncology Group
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Texas Oncology, PA - South Austin Cancer Center
    • Virginia
      • Blacksburg, Virginia, Forenede Stater, 24060
        • Blue Ridge Cancer Care
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • Wisconsin Institutes for Medical Research
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      • Poitiers, Frankrig, 86000
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      • Rennes Cedex 9, Frankrig, 35033
        • Local Institution
      • Toulouse Cedex 9, Frankrig, 31059
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      • Vandoeuvre-les-nancy, Frankrig, 54511
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  • Holland
      • Breda, Holland, 4818 CK
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      • Harderwijk, Holland, 3844 DG
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      • Hertogenbosch, Holland, 5223 GZ
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      • Nieuwegein, Holland, 3435 CM
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  • Hong Kong
      • Hong Kong, Hong Kong, 8525
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      • New Territories, Hong Kong, 8520
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  • Irland
      • Dublin, Irland, 24
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      • Galway, Irland
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  • Israel
      • Beer Sheva, Israel, 84101
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      • Haifa, Israel, 31096
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      • Jerusalem, Israel, 91120
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      • Nahariya, Israel, 22100
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      • Petah-Tikva, Israel, 49100
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      • Rehovot, Israel, 76100
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      • Tel Aviv, Israel, 64239
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      • Tel-aviv, Israel, 69710
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      • Tel-hashomer, Israel, 52621
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      • Zerifin, Israel, 70300
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  • Italien
      • Benevento, Italien, 82100
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      • Bologna, Italien, 40138
        • Local Institution
      • Lido Di Camaiore, Italien, 55041
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      • Lucca, Italien, 55100
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      • Monza, Italien, 20052
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      • Padova, Italien, 35128
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      • Perugia, Italien, 06156
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      • Siena, Italien, 53100
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      • Sondrio, Italien, 23100
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      • Terni, Italien, 05100
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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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      • Osakasayama-city, Japan, 5898511
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      • Sapporo Hokkaido, Japan, 003-080
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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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      • Osaka-shi, Osaka, Japan, 5340021
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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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  • Kina
      • Beijing, Kina, 100032
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      • Beijing, Kina, 100071
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    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
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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
        • Local Institution
      • Xi'an, Shaanxi, Kina, 710061
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    • Xinjiang
      • Urumqi, Xinjiang, Kina, 830011
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    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
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  • Korea, Republikken
      • Busan, Korea, Republikken, 602-739
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      • Daegu, Korea, Republikken, 700-712
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      • Gyeonggi-do, Korea, Republikken, 463-802
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      • Seoul, Korea, Republikken, 110-744
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      • Seoul, Korea, Republikken, 138-736
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      • Seoul, Korea, Republikken, 134-791
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      • Seoul, Korea, Republikken, 135-720
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      • Seoul, Korea, Republikken, 136-705
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      • Suwon, Korea, Republikken, 443-721
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    • Chungcheongbuk-do
      • Cheonju-si, Chungcheongbuk-do, Korea, Republikken, 361-771
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      • Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
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      • Seoul, Kangnam-gu, Korea, Republikken, 135-710
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      • Seoul, Seodaemungu, Korea, Republikken, 120-752
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    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64060
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  • Peru
      • Arequipa, Peru
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      • Cercado, Peru
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      • Lima, Peru, LIMA 11
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    • LA Libertad
      • Trujillo, LA Libertad, Peru
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  • Polen
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  • Portugal
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      • Porto, Portugal, 4200-072
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      • Santa Maria Da Feira, Portugal, 4520211
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      • Valencia, Spanien, 46014
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      • Valencia, Spanien, 46015
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    • Vizcaya
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      • Gothenburg, Sverige, 413 45
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      • Lund, Sverige, 221 85
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      • Stockholm, Sverige, 17176
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      • Umea, Sverige, SE-901 85
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  • Sydafrika
      • Cape Town, Sydafrika, 7925
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      • Durban, Sydafrika, 4067
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    • Gauteng
      • Vereeniging, Gauteng, Sydafrika, 1939
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    • Western CAPE
      • Panorama,cape Town, Western CAPE, Sydafrika, 7500
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  • Taiwan
      • Changhua City, Taiwan, 500
        • Local Institution
      • Chiayi, Taiwan, 61363
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      • Kaohsiung County, Taiwan, 83301
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      • Taichung, Taiwan, 404
        • Local Institution
      • Taichung, Taiwan, 407.5
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      • Taipei, Taiwan, 112
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      • Taipei City, Taiwan, 100
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  • Thailand
      • Bangkok, Thailand, 10400
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      • Bangkok, Thailand, 10700
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      • Bangkok, Thailand, 10330
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      • Chiang Mai, Thailand, 50200
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    • Tungpayathai
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  • Tjekkiet
      • Prague 2, Tjekkiet, 12808
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      • Praha 5, Tjekkiet, 150 06
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        • Local Institution
      • Pribram V-Zdabor, Tjekkiet, 26195
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      • Znojmo, Tjekkiet, 669 02
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    • Poruba
      • Ostrava, Poruba, Tjekkiet, 70852
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  • Tyskland
      • Bad Berka, Tyskland, 99437
        • Local Institution
      • Bochum, Tyskland, 44791
        • Local Institution
      • Darmstadt, Tyskland, 64283
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      • Dresden, Tyskland, 01307
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      • Frankfurt Am Main, Tyskland, 60590
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      • Gauting, Tyskland, 82131
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      • Grosshandsdorf, Tyskland, 22927
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      • Hamburg, Tyskland, D-21075
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      • Heidelberg, Tyskland, 69126
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      • Kassel, Tyskland, 34125
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      • Lubeck, Tyskland, 23538
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      • Mainz, Tyskland, 55131
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      • Budapest, Ungarn, 1125
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      • Deszk, Ungarn, 6772
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      • Farkasgyepu, Ungarn, 8582
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      • Gyula, Ungarn, 5703
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      • Matrahaza, Ungarn, 3233
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      • Nyiregyhaza, Ungarn, 4400
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      • Pecs, Ungarn, 7602
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      • Sopron, Ungarn, 9400
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      • Szekesfehervar, Ungarn, 8000
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      • Szolnok, Ungarn, 5000
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      • Graz, Østrig, 8036
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      • Linz, Østrig, 4020
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      • Salzburg, Østrig, 5020
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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: Ipilimumab
Andre navne:
  • BMS-734016
Medicin: Carboplatin
Andre navne:
  • Paraplatin®
Medicin: Paclitaxel
Andre navne:
  • Taxol®
Placebo komparator: 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
Medicin: Placebo
Medicin: Carboplatin
Andre navne:
  • Paraplatin®
Medicin: Paclitaxel
Andre navne:
  • Taxol®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. januar 2011

Primær færdiggørelse (Faktiske)

9. juni 2015

Studieafslutning (Faktiske)

22. august 2017

Datoer for studieregistrering

Først indsendt

24. januar 2011

Først indsendt, der opfyldte QC-kriterier

27. januar 2011

Først opslået (Skøn)

28. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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