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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 de junio de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

1289

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Berka, Alemania, 99437
        • Local Institution
      • Bochum, Alemania, 44791
        • Local Institution
      • Darmstadt, Alemania, 64283
        • Local Institution
      • Dresden, Alemania, 01307
        • Local Institution
      • Frankfurt Am Main, Alemania, 60590
        • Local Institution
      • Gauting, Alemania, 82131
        • Local Institution
      • Grosshandsdorf, Alemania, 22927
        • Local Institution
      • Hamburg, Alemania, D-21075
        • Local Institution
      • Heidelberg, Alemania, 69126
        • Local Institution
      • Kassel, Alemania, 34125
        • Local Institution
      • Lubeck, Alemania, 23538
        • Local Institution
      • Mainz, Alemania, 55131
        • Local Institution
      • Muenchen, Alemania, 81925
        • Local Institution
      • Neumunster, Alemania, 24534
        • Local Institution
      • Nuernberg, Alemania, 90419
        • Local Institution
      • Regensburg, Alemania, 93049
        • Local Institution
      • Tuebingen, Alemania, 72076
        • Local Institution
      • Ulm, Alemania, 89081
        • Local Institution
      • Villingen-Schwenningen, Alemania, 78052
        • Local Institution
  • 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
  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution
      • Frankston, Victoria, Australia, 3199
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Wodonga, Victoria, Australia, 3690
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Linz, Austria, 4020
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
  • Brasil
      • Porto Alegre, Brasil, 90430
        • Local Institution
      • Ribeirao Preto, Brasil, 14015
        • Local Institution
      • Rio de Janeiro, Brasil, 20231-050
        • Local Institution
      • Sao Paulo, Brasil, 01224-010
        • Local Institution
      • Sao Paulo, Brasil, 04039-901
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brasil, 60160-230
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30150-270
        • Local Institution
    • Parana
      • Curitiba, Parana, Brasil, 81520-060
        • Local Institution
    • RIO Grande DO SUL
      • Passo Fundo, RIO Grande DO SUL, Brasil, 99010260
        • Local Institution
    • SAO Paulo
      • Barretos, SAO Paulo, Brasil, 14784
        • Local Institution
      • Sao Jose dos Campos, SAO Paulo, Brasil, 12245
        • Local Institution
  • Bélgica
      • Aalst, Bélgica, 9300
        • Local Institution
      • Liege, Bélgica, 4000
        • Local Institution
      • Sint Niklaas, Bélgica, 9100
        • Local Institution
      • Yvoir, Bélgica, 5530
        • Local Institution
  • Canadá
      • Oshawa, Canadá, L1G 2B9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canadá, H2W 1S6
        • Local Institution
      • Montreal, Quebec, Canadá, H3T 1E2
        • Local Institution
      • Montreal, Quebec, Canadá, H4J 1C5
        • Local Institution
  • Chequia
      • Prague 2, Chequia, 12808
        • Local Institution
      • Praha 5, Chequia, 150 06
        • Local Institution
      • Praha 8, Chequia, 180 81
        • Local Institution
      • Pribram V-Zdabor, Chequia, 26195
        • Local Institution
      • Usti Nad Labem, Chequia, 401 13
        • Local Institution
      • Znojmo, Chequia, 669 02
        • Local Institution
    • Poruba
      • Ostrava, Poruba, Chequia, 70852
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7520378
        • Local Institution
      • Santiago, Metropolitana, Chile, 8380455
        • Local Institution
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540364
        • Local Institution
  • Colombia
    • Cordoba
      • Monteria, Cordoba, Colombia
        • Local Institution
    • Risaralda
      • Pereira, Risaralda, Colombia
        • Local Institution
  • Corea, república de
      • Busan, Corea, república de, 602-739
        • Local Institution
      • Daegu, Corea, república de, 700-712
        • Local Institution
      • Gyeonggi-do, Corea, república de, 463-802
        • Local Institution
      • Seoul, Corea, república de, 110-744
        • Local Institution
      • Seoul, Corea, república de, 138-736
        • Local Institution
      • Seoul, Corea, república de, 134-791
        • Local Institution
      • Seoul, Corea, república de, 135-720
        • Local Institution
      • Seoul, Corea, república de, 136-705
        • Local Institution
      • Seoul, Corea, república de, 137-701
        • Local Institution
      • Seoul, Corea, república de, 156-755
        • Local Institution
      • Suwon, Corea, república de, 443-721
        • Local Institution
    • Chungcheongbuk-do
      • Cheonju-si, Chungcheongbuk-do, Corea, república de, 361-771
        • Local Institution
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Corea, república de, 410-769
        • Local Institution
      • Suwon-si, Gyeonggi-do, Corea, república de, 442-723
        • Local Institution
    • Kangnam-gu
      • Seoul, Kangnam-gu, Corea, república de, 135-710
        • Local Institution
    • Seodaemungu
      • Seoul, Seodaemungu, Corea, república de, 120-752
        • Local Institution
  • Dinamarca
      • Aalborg, Dinamarca, 9000
        • Local Institution
      • Herlev, Dinamarca, 2730
        • Local Institution
      • Hillerod, Dinamarca, 3400
        • Local Institution
      • Naestved, Dinamarca, 4700
        • Local Institution
      • Odense, Dinamarca, 5000
        • Local Institution
  • España
      • Avila, España, 05004
        • Local Institution
      • Benidorm-alicante, España, 03501
        • Local Institution
      • Castellon, España, 12002
        • Local Institution
      • Madrid, España, 28041
        • Local Institution
      • Madrid, España, 28033
        • Local Institution
      • Manresa, España, 08243
        • Local Institution
      • Ourense, España, 32005
        • Local Institution
      • Valencia, España, 46014
        • Local Institution
      • Valencia, España, 46015
        • Local Institution
    • Vizcaya
      • Barakaldo, Vizcaya, España, 48903
        • Local Institution
  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92123
        • Sharp Memorial Hospital
    • Connecticut
      • West Haven, Connecticut, Estados Unidos, 06516
        • VA Connecticut Healthcare System
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Lynn Cancer Institute Center For Hematology-Oncology
      • Jacksonville, Florida, Estados Unidos, 32256
        • Integrated Community Oncology Network
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois at Chicago Medical Center
      • Quincy, Illinois, Estados Unidos, 62301
        • Quincy Medical Group
      • Skokie, Illinois, Estados Unidos, 60076
        • Presence Medical Group Hematology Oncology
      • Springfield, Illinois, Estados Unidos, 62794-9678
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46237
        • St. Francis Hospital & Health Centers
      • New Albany, Indiana, Estados Unidos, 47150
        • Floyd Memorial Cancer Center of Indiana
    • Kentucky
      • Hazard, Kentucky, Estados Unidos, 41701
        • Kentucky Cancer Clinic
      • Louisville, Kentucky, Estados Unidos, 40207
        • Norton Cancer Institute
      • Mount Sterling, Kentucky, Estados Unidos, 40353
        • Montgomery Cancer Center
    • Michigan
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • St Joseph Mercy Hospital
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64131
        • University of Kansas Cancer Center
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Lake Success, New York, Estados Unidos, 11042
        • Clinical Research Alliance, Inc.
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Durham Va Medical Center (111g)
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Carolina BioOncology Institute
      • Lexington, North Carolina, Estados Unidos, 27295
        • Novant Health Oncology Specialists
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Gabrail Cancer Center Research
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74146
        • Oklahoma Oncology And Hematology, Pc Dba
    • Oregon
      • Portland, Oregon, Estados Unidos, 97227
        • Kaiser Permanente Northwest Region
    • Pennsylvania
      • Sayre, Pennsylvania, Estados Unidos, 18840
        • Guthrie Medical Group, P.C.
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29209
        • WJB Dorn VA Medical Center
      • Greenville, South Carolina, Estados Unidos, 29615
        • Cancer Center Of The Carolinas
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37421
        • Associated in Oncology and Hematology
      • Knoxville, Tennessee, Estados Unidos, 37909
        • Tennessee Cancer Specialists
      • Knoxville, Tennessee, Estados Unidos, 37916
        • Thompson Oncology Group
    • Texas
      • Austin, Texas, Estados Unidos, 78745
        • Texas Oncology, PA - South Austin Cancer Center
    • Virginia
      • Blacksburg, Virginia, Estados Unidos, 24060
        • Blue Ridge Cancer Care
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • Wisconsin Institutes for Medical Research
  • Federación Rusa
      • Chelyabinsk, Federación Rusa, 454087
        • Local Institution
      • Kazan, Federación Rusa, 420029
        • Local Institution
      • Moscow, Federación Rusa, 115478
        • Local Institution
      • Moscow, Federación Rusa, 125009
        • Local Institution
      • Pyatigorsk, Federación Rusa, 357502
        • Local Institution
      • Saint Petersburg, Federación Rusa, 197758
        • Local Institution
      • St-Peterburg, Federación Rusa, 198255
        • Local Institution
      • St. Petersburg, Federación Rusa, 197022
        • Local Institution
      • Tula, Federación Rusa, 300053
        • Local Institution
  • Francia
      • Caen Cedex 05, Francia, 14076
        • Local Institution
      • Marseille Cedex 20, Francia, 13915
        • Local Institution
      • Paris, Francia, 75014
        • Local Institution
      • Poitiers, Francia, 86000
        • Local Institution
      • Rennes Cedex 9, Francia, 35033
        • Local Institution
      • Toulouse Cedex 9, Francia, 31059
        • Local Institution
      • Vandoeuvre-les-nancy, Francia, 54511
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong, 8525
        • Local Institution
      • Hong Kong, Hong Kong
        • Local Institution
      • New Territories, Hong Kong, 8520
        • Local Institution
  • Hungría
      • Budapest, Hungría, 1121
        • Local Institution
      • Budapest, Hungría, 1125
        • Local Institution
      • Deszk, Hungría, 6772
        • Local Institution
      • Farkasgyepu, Hungría, 8582
        • Local Institution
      • Gyula, Hungría, 5703
        • Local Institution
      • Matrahaza, Hungría, 3233
        • Local Institution
      • Nyiregyhaza, Hungría, 4400
        • Local Institution
      • Pecs, Hungría, 7602
        • Local Institution
      • Sopron, Hungría, 9400
        • Local Institution
      • Szekesfehervar, Hungría, 8000
        • Local Institution
      • Szolnok, Hungría, 5000
        • Local Institution
  • Irlanda
      • Dublin, Irlanda, 24
        • Local Institution
      • Dublin, Irlanda, 4
        • Local Institution
      • Dublin, Irlanda, 8
        • Local Institution
      • Galway, Irlanda
        • Local Institution
  • Israel
      • Beer Sheva, Israel, 84101
        • Local Institution
      • Haifa, Israel, 31096
        • Local Institution
      • Jerusalem, Israel, 91120
        • Local Institution
      • Nahariya, Israel, 22100
        • Local Institution
      • Petah-Tikva, Israel, 49100
        • Local Institution
      • Rehovot, Israel, 76100
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
      • Tel-aviv, Israel, 69710
        • Local Institution
      • Tel-hashomer, Israel, 52621
        • Local Institution
      • Zerifin, Israel, 70300
        • Local Institution
  • Italia
      • Benevento, Italia, 82100
        • Local Institution
      • Bologna, Italia, 40138
        • Local Institution
      • Lido Di Camaiore, Italia, 55041
        • Local Institution
      • Lucca, Italia, 55100
        • Local Institution
      • Monza, Italia, 20052
        • Local Institution
      • Padova, Italia, 35128
        • Local Institution
      • Perugia, Italia, 06156
        • Local Institution
      • Siena, Italia, 53100
        • Local Institution
      • Sondrio, Italia, 23100
        • Local Institution
      • Terni, Italia, 05100
        • Local Institution
      • Treviglio, Italia, 24047
        • Local Institution
  • Japón
      • Akashi, Hyogo, Japón, 6738558
        • Local Institution
      • Fukuoka, Japón, 8128582
        • Local Institution
      • Matsuyama, Ehime, Japón, 791-0280
        • Local Institution
      • Osakasayama-city, Japón, 5898511
        • Local Institution
      • Sapporo Hokkaido, Japón, 003-080
        • Local Institution
      • Sapporo, Hokkaido, Japón, 0608648
        • Local Institution
      • Sendai, Miyagi, Japón, 980-0873
        • Local Institution
      • Takatsuki, Japón, 569-8686
        • Local Institution
      • Tokyo, Japón, 135-8550
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japón, 4648681
        • Local Institution
      • Nagoya-shi, Aichi, Japón, 4600001
        • Local Institution
    • Chiba
      • Kashiwa, Chiba, Japón, 277-8577
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japón, 9208641
        • Local Institution
    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japón, 2360051
        • Local Institution
      • Yokohama-shi, Kanagawa, Japón, 2408555
        • Local Institution
    • Miyagi
      • Natori-shi, Miyagi, Japón, 9811293
        • Local Institution
      • Sendai, Miyagi, Japón, 9808574
        • Local Institution
    • Okayama
      • Kurashiki-shi, Okayama, Japón, 7010192
        • Local Institution
      • Kurashiki-shi, Okayama, Japón, 710-8602
        • Local Institution
    • Osaka
      • Hirakata-shi, Osaka, Japón, 5731191
        • Local Institution
      • Osaka-shi, Osaka, Japón, 5340021
        • Local Institution
    • Shizuoka
      • Sunto-gun, Shizuoka, Japón, 411-8777
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japón, 104-0045
        • Local Institution
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japón, 7550241
        • Local Institution
  • México
    • Distrito Federal
      • Mexico, Distrito Federal, México, 06760
        • Local Institution
    • Jalisco
      • Zapopan, Jalisco, México, 45170
        • Local Institution
    • Nuevo LEON
      • Monterrey, Nuevo LEON, México, 64060
        • Local Institution
  • Países Bajos
      • Breda, Países Bajos, 4818 CK
        • Local Institution
      • Harderwijk, Países Bajos, 3844 DG
        • Local Institution
      • Hertogenbosch, Países Bajos, 5223 GZ
        • Local Institution
      • Nieuwegein, Países Bajos, 3435 CM
        • Local Institution
  • Perú
      • Arequipa, Perú
        • Local Institution
      • Cercado, Perú
        • Local Institution
      • Lima, Perú, LIMA 11
        • Local Institution
    • LA Libertad
      • Trujillo, LA Libertad, Perú
        • Local Institution
  • Polonia
      • Elblag, Polonia, 82-300
        • Local Institution
      • Gdansk, Polonia, 80-952
        • Local Institution
      • Gdansk- Zaspa, Polonia, 80-462
        • Local Institution
      • Grudziadz, Polonia, 86-300
        • Local Institution
      • Olsztyn, Polonia, 10-357
        • Local Institution
      • Otwock, Polonia, 05-400
        • Local Institution
      • Poznan, Polonia, 60 569
        • Local Institution
      • Szczecin, Polonia, 70-891
        • Local Institution
      • Torun, Polonia, 87-100
        • Local Institution
      • Warsaw, Polonia, 02-781
        • Local Institution
  • Porcelana
      • Beijing, Porcelana, 100032
        • Local Institution
      • Beijing, Porcelana, 100071
        • Local Institution
      • Beijing, Porcelana, 100142
        • Local Institution
      • Beijing, Porcelana, 100853
        • Local Institution
      • Santiago, Porcelana, 7630370
        • Local Institution
      • Shanghai, Porcelana, 200030
        • Local Institution
      • Shanghai, Porcelana, 200433
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510060
        • Local Institution
      • Guanzhou, Guangdong, Porcelana, 510080
        • Local Institution
      • Shantou, Guangdong, Porcelana, 515041
        • Local Institution
    • Hubei
      • Wuhan, Hubei, Porcelana, 430023
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210002
        • Local Institution
      • Nanjing, Jiangsu, Porcelana, 210009
        • Local Institution
      • Suzhou, Jiangsu, Porcelana, 215006
        • Local Institution
    • Jilin
      • Changchun, Jilin, Porcelana, 130012
        • Local Institution
    • Shaanxi
      • Xi'an, Shaanxi, Porcelana, 710038
        • Local Institution
      • Xi'an, Shaanxi, Porcelana, 710061
        • Local Institution
    • Xinjiang
      • Urumqi, Xinjiang, Porcelana, 830011
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310016
        • Local Institution
  • Portugal
      • Lisboa, Portugal, 1099023
        • Local Institution
      • Lisboa, Portugal, 1769-001
        • Local Institution
      • Porto, Portugal, 4200-072
        • Local Institution
      • Santa Maria Da Feira, Portugal, 4520211
        • Local Institution
      • Vila Nova De Gaia, Portugal, 4434-502
        • Local Institution
    • Coimbra
      • Sao Martinho Do Bispo, Coimbra, Portugal, 3041801
        • Local Institution
  • Reino Unido
      • Nottingham, Reino Unido, NG51PB
        • Local Institution
      • Sheffield, Reino Unido, S10 2SJ
        • Local Institution
    • Angus/forfarshire
      • Dundee, Angus/forfarshire, Reino Unido, DD1 9SY
        • Local Institution
    • Cornwall
      • Truro, Cornwall, Reino Unido, TR1 3LJ
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, Reino Unido, SO16 6YD
        • Local Institution
  • Rumania
      • Bucharest, Rumania, 030171
        • Local Institution
      • Bucuresti, Rumania, 010976
        • Local Institution
      • Cluj Napoca, Rumania, 400058
        • Local Institution
      • Sibiu, Rumania, 550245
        • Local Institution
      • Suceava, Rumania, 720237
        • Local Institution
      • Timisoara, Rumania, 300239
        • Local Institution
  • Singapur
      • Singapore, Singapur, 308433
        • Local Institution
  • Sudáfrica
      • Cape Town, Sudáfrica, 7925
        • Local Institution
      • Durban, Sudáfrica, 4067
        • Local Institution
    • Gauteng
      • Vereeniging, Gauteng, Sudáfrica, 1939
        • Local Institution
    • Western CAPE
      • Panorama,cape Town, Western CAPE, Sudáfrica, 7500
        • Local Institution
  • Suecia
      • Gothenburg, Suecia, 413 45
        • Local Institution
      • Lund, Suecia, 221 85
        • Local Institution
      • Stockholm, Suecia, 17176
        • Local Institution
      • Umea, Suecia, SE-901 85
        • Local Institution
  • Suiza
      • Basel, Suiza, 4031
        • Local Institution
      • Winterthur, Suiza, 8401
        • Local Institution
  • Tailandia
      • Bangkok, Tailandia, 10400
        • Local Institution
      • Bangkok, Tailandia, 10700
        • Local Institution
      • Bangkok, Tailandia, 10330
        • Local Institution
      • Chiang Mai, Tailandia, 50200
        • Local Institution
      • Songkhla, Tailandia, 90110
        • Local Institution
    • Tungpayathai
      • Bangkok, Tungpayathai, Tailandia, 10400
        • Local Institution
  • Taiwán
      • Changhua City, Taiwán, 500
        • Local Institution
      • Chiayi, Taiwán, 61363
        • Local Institution
      • Kaohsiung County, Taiwán, 83301
        • Local Institution
      • Taichung, Taiwán, 404
        • Local Institution
      • Taichung, Taiwán, 407.5
        • Local Institution
      • Taipei, Taiwán, 112
        • Local Institution
      • Taipei, Taiwán
        • Local Institution
      • Taipei City, Taiwán, 100
        • Local Institution

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Droga: Ipilimumab
Otros nombres:
  • BMS-734016
Droga: Carboplatino
Otros nombres:
  • Paraplatin®
Droga: Paclitaxel
Otros nombres:
  • Taxol®
Comparador de placebos: 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
Droga: Placebo
Droga: Carboplatino
Otros nombres:
  • Paraplatin®
Droga: Paclitaxel
Otros nombres:
  • Taxol®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bristol-Myers Squibb

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de enero de 2011

Finalización primaria (Actual)

9 de junio de 2015

Finalización del estudio (Actual)

22 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2011

Publicado por primera vez (Estimar)

28 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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