Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

16. juni 2020 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

1289

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • 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
  • Belgia
      • Aalst, Belgia, 9300
        • Local Institution
      • Liege, Belgia, 4000
        • Local Institution
      • Sint Niklaas, Belgia, 9100
        • Local Institution
      • Yvoir, Belgia, 5530
        • 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
  • Canada
      • Oshawa, Canada, L1G 2B9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • Local Institution
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
      • Montreal, Quebec, Canada, H4J 1C5
        • 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
  • Danmark
      • Aalborg, Danmark, 9000
        • Local Institution
      • Herlev, Danmark, 2730
        • Local Institution
      • Hillerod, Danmark, 3400
        • Local Institution
      • Naestved, Danmark, 4700
        • Local Institution
      • Odense, Danmark, 5000
        • Local Institution
  • Den russiske føderasjonen
      • Chelyabinsk, Den russiske føderasjonen, 454087
        • Local Institution
      • Kazan, Den russiske føderasjonen, 420029
        • Local Institution
      • Moscow, Den russiske føderasjonen, 115478
        • Local Institution
      • Moscow, Den russiske føderasjonen, 125009
        • Local Institution
      • Pyatigorsk, Den russiske føderasjonen, 357502
        • Local Institution
      • Saint Petersburg, Den russiske føderasjonen, 197758
        • Local Institution
      • St-Peterburg, Den russiske føderasjonen, 198255
        • Local Institution
      • St. Petersburg, Den russiske føderasjonen, 197022
        • Local Institution
      • Tula, Den russiske føderasjonen, 300053
        • Local Institution
  • Forente stater
    • California
      • San Diego, California, Forente stater, 92123
        • Sharp Memorial Hospital
    • Connecticut
      • West Haven, Connecticut, Forente stater, 06516
        • VA Connecticut Healthcare System
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Lynn Cancer Institute Center For Hematology-Oncology
      • Jacksonville, Florida, Forente stater, 32256
        • Integrated Community Oncology Network
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois at Chicago Medical Center
      • Quincy, Illinois, Forente stater, 62301
        • Quincy Medical Group
      • Skokie, Illinois, Forente stater, 60076
        • Presence Medical Group Hematology Oncology
      • Springfield, Illinois, Forente stater, 62794-9678
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46237
        • St. Francis Hospital & Health Centers
      • New Albany, Indiana, Forente stater, 47150
        • Floyd Memorial Cancer Center of Indiana
    • Kentucky
      • Hazard, Kentucky, Forente stater, 41701
        • Kentucky Cancer Clinic
      • Louisville, Kentucky, Forente stater, 40207
        • Norton Cancer Institute
      • Mount Sterling, Kentucky, Forente stater, 40353
        • Montgomery Cancer Center
    • Michigan
      • Ypsilanti, Michigan, Forente stater, 48197
        • St Joseph Mercy Hospital
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • University of Kansas Cancer Center
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Lake Success, New York, Forente stater, 11042
        • Clinical Research Alliance, Inc.
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Durham Va Medical Center (111g)
      • Huntersville, North Carolina, Forente stater, 28078
        • Carolina Biooncology Institute
      • Lexington, North Carolina, Forente stater, 27295
        • Novant Health Oncology Specialists
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • Gabrail Cancer Center Research
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74146
        • Oklahoma Oncology And Hematology, Pc Dba
    • Oregon
      • Portland, Oregon, Forente stater, 97227
        • Kaiser Permanente Northwest Region
    • Pennsylvania
      • Sayre, Pennsylvania, Forente stater, 18840
        • Guthrie Medical Group, P.C.
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29209
        • WJB Dorn VA Medical Center
      • Greenville, South Carolina, Forente stater, 29615
        • Cancer Center Of The Carolinas
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37421
        • Associated in Oncology and Hematology
      • Knoxville, Tennessee, Forente stater, 37909
        • Tennessee Cancer Specialists
      • Knoxville, Tennessee, Forente stater, 37916
        • Thompson Oncology Group
    • Texas
      • Austin, Texas, Forente stater, 78745
        • Texas Oncology, PA - South Austin Cancer Center
    • Virginia
      • Blacksburg, Virginia, Forente stater, 24060
        • Blue Ridge Cancer Care
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53705
        • Wisconsin Institutes for Medical Research
  • Frankrike
      • Caen Cedex 05, Frankrike, 14076
        • Local Institution
      • Marseille Cedex 20, Frankrike, 13915
        • Local Institution
      • Paris, Frankrike, 75014
        • Local Institution
      • Poitiers, Frankrike, 86000
        • Local Institution
      • Rennes Cedex 9, Frankrike, 35033
        • Local Institution
      • Toulouse Cedex 9, Frankrike, 31059
        • Local Institution
      • Vandoeuvre-les-nancy, Frankrike, 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
  • Irland
      • Dublin, Irland, 24
        • Local Institution
      • Dublin, Irland, 4
        • Local Institution
      • Dublin, Irland, 8
        • Local Institution
      • Galway, Irland
        • 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
  • Japan
      • Akashi, Hyogo, Japan, 6738558
        • Local Institution
      • Fukuoka, Japan, 8128582
        • Local Institution
      • Matsuyama, Ehime, Japan, 791-0280
        • Local Institution
      • Osakasayama-city, Japan, 5898511
        • Local Institution
      • Sapporo Hokkaido, Japan, 003-080
        • Local Institution
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution
      • Sendai, Miyagi, Japan, 980-0873
        • Local Institution
      • Takatsuki, Japan, 569-8686
        • Local Institution
      • Tokyo, Japan, 135-8550
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution
      • Nagoya-shi, Aichi, Japan, 4600001
        • Local Institution
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution
    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japan, 2360051
        • Local Institution
      • Yokohama-shi, Kanagawa, Japan, 2408555
        • Local Institution
    • Miyagi
      • Natori-shi, Miyagi, Japan, 9811293
        • Local Institution
      • Sendai, Miyagi, Japan, 9808574
        • Local Institution
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 7010192
        • Local Institution
      • Kurashiki-shi, Okayama, Japan, 710-8602
        • Local Institution
    • Osaka
      • Hirakata-shi, Osaka, Japan, 5731191
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5340021
        • Local Institution
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7550241
        • Local Institution
  • Kina
      • Beijing, Kina, 100032
        • Local Institution
      • Beijing, Kina, 100071
        • Local Institution
      • Beijing, Kina, 100142
        • Local Institution
      • Beijing, Kina, 100853
        • Local Institution
      • Santiago, Kina, 7630370
        • Local Institution
      • Shanghai, Kina, 200030
        • Local Institution
      • Shanghai, Kina, 200433
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Local Institution
      • Guanzhou, Guangdong, Kina, 510080
        • Local Institution
      • Shantou, Guangdong, Kina, 515041
        • Local Institution
    • Hubei
      • Wuhan, Hubei, Kina, 430023
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002
        • Local Institution
      • Nanjing, Jiangsu, Kina, 210009
        • Local Institution
      • Suzhou, Jiangsu, Kina, 215006
        • Local Institution
    • Jilin
      • Changchun, Jilin, Kina, 130012
        • Local Institution
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710038
        • Local Institution
      • Xi'an, Shaanxi, Kina, 710061
        • Local Institution
    • Xinjiang
      • Urumqi, Xinjiang, Kina, 830011
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Local Institution
  • Korea, Republikken
      • Busan, Korea, Republikken, 602-739
        • Local Institution
      • Daegu, Korea, Republikken, 700-712
        • Local Institution
      • Gyeonggi-do, Korea, Republikken, 463-802
        • Local Institution
      • Seoul, Korea, Republikken, 110-744
        • Local Institution
      • Seoul, Korea, Republikken, 138-736
        • Local Institution
      • Seoul, Korea, Republikken, 134-791
        • Local Institution
      • Seoul, Korea, Republikken, 135-720
        • Local Institution
      • Seoul, Korea, Republikken, 136-705
        • Local Institution
      • Seoul, Korea, Republikken, 137-701
        • Local Institution
      • Seoul, Korea, Republikken, 156-755
        • Local Institution
      • Suwon, Korea, Republikken, 443-721
        • Local Institution
    • Chungcheongbuk-do
      • Cheonju-si, Chungcheongbuk-do, Korea, Republikken, 361-771
        • Local Institution
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
        • Local Institution
      • Suwon-si, Gyeonggi-do, Korea, Republikken, 442-723
        • Local Institution
    • Kangnam-gu
      • Seoul, Kangnam-gu, Korea, Republikken, 135-710
        • Local Institution
    • Seodaemungu
      • Seoul, Seodaemungu, Korea, Republikken, 120-752
        • Local Institution
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06760
        • Local Institution
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45170
        • Local Institution
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64060
        • Local Institution
  • Nederland
      • Breda, Nederland, 4818 CK
        • Local Institution
      • Harderwijk, Nederland, 3844 DG
        • Local Institution
      • Hertogenbosch, Nederland, 5223 GZ
        • Local Institution
      • Nieuwegein, Nederland, 3435 CM
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Cercado, Peru
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
    • LA Libertad
      • Trujillo, LA Libertad, Peru
        • Local Institution
  • Polen
      • Elblag, Polen, 82-300
        • Local Institution
      • Gdansk, Polen, 80-952
        • Local Institution
      • Gdansk- Zaspa, Polen, 80-462
        • Local Institution
      • Grudziadz, Polen, 86-300
        • Local Institution
      • Olsztyn, Polen, 10-357
        • Local Institution
      • Otwock, Polen, 05-400
        • Local Institution
      • Poznan, Polen, 60 569
        • Local Institution
      • Szczecin, Polen, 70-891
        • Local Institution
      • Torun, Polen, 87-100
        • Local Institution
      • Warsaw, Polen, 02-781
        • 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
  • Romania
      • Bucharest, Romania, 030171
        • Local Institution
      • Bucuresti, Romania, 010976
        • Local Institution
      • Cluj Napoca, Romania, 400058
        • Local Institution
      • Sibiu, Romania, 550245
        • Local Institution
      • Suceava, Romania, 720237
        • Local Institution
      • Timisoara, Romania, 300239
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
  • Spania
      • Avila, Spania, 05004
        • Local Institution
      • Benidorm-alicante, Spania, 03501
        • Local Institution
      • Castellon, Spania, 12002
        • Local Institution
      • Madrid, Spania, 28041
        • Local Institution
      • Madrid, Spania, 28033
        • Local Institution
      • Manresa, Spania, 08243
        • Local Institution
      • Ourense, Spania, 32005
        • Local Institution
      • Valencia, Spania, 46014
        • Local Institution
      • Valencia, Spania, 46015
        • Local Institution
    • Vizcaya
      • Barakaldo, Vizcaya, Spania, 48903
        • Local Institution
  • Storbritannia
      • Nottingham, Storbritannia, NG51PB
        • Local Institution
      • Sheffield, Storbritannia, S10 2SJ
        • Local Institution
    • Angus/forfarshire
      • Dundee, Angus/forfarshire, Storbritannia, DD1 9SY
        • Local Institution
    • Cornwall
      • Truro, Cornwall, Storbritannia, TR1 3LJ
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, Storbritannia, SO16 6YD
        • Local Institution
  • Sveits
      • Basel, Sveits, 4031
        • Local Institution
      • Winterthur, Sveits, 8401
        • Local Institution
  • Sverige
      • Gothenburg, Sverige, 413 45
        • Local Institution
      • Lund, Sverige, 221 85
        • Local Institution
      • Stockholm, Sverige, 17176
        • Local Institution
      • Umea, Sverige, SE-901 85
        • Local Institution
  • Sør-Afrika
      • Cape Town, Sør-Afrika, 7925
        • Local Institution
      • Durban, Sør-Afrika, 4067
        • Local Institution
    • Gauteng
      • Vereeniging, Gauteng, Sør-Afrika, 1939
        • Local Institution
    • Western CAPE
      • Panorama,cape Town, Western CAPE, Sør-Afrika, 7500
        • Local Institution
  • Taiwan
      • Changhua City, Taiwan, 500
        • Local Institution
      • Chiayi, Taiwan, 61363
        • Local Institution
      • Kaohsiung County, Taiwan, 83301
        • Local Institution
      • Taichung, Taiwan, 404
        • Local Institution
      • Taichung, Taiwan, 407.5
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
      • Taipei, Taiwan
        • Local Institution
      • Taipei City, Taiwan, 100
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
      • Bangkok, Thailand, 10700
        • Local Institution
      • Bangkok, Thailand, 10330
        • Local Institution
      • Chiang Mai, Thailand, 50200
        • Local Institution
      • Songkhla, Thailand, 90110
        • Local Institution
    • Tungpayathai
      • Bangkok, Tungpayathai, Thailand, 10400
        • Local Institution
  • Tsjekkia
      • Prague 2, Tsjekkia, 12808
        • Local Institution
      • Praha 5, Tsjekkia, 150 06
        • Local Institution
      • Praha 8, Tsjekkia, 180 81
        • Local Institution
      • Pribram V-Zdabor, Tsjekkia, 26195
        • Local Institution
      • Usti Nad Labem, Tsjekkia, 401 13
        • Local Institution
      • Znojmo, Tsjekkia, 669 02
        • Local Institution
    • Poruba
      • Ostrava, Poruba, Tsjekkia, 70852
        • Local Institution
  • Tyskland
      • Bad Berka, Tyskland, 99437
        • Local Institution
      • Bochum, Tyskland, 44791
        • Local Institution
      • Darmstadt, Tyskland, 64283
        • Local Institution
      • Dresden, Tyskland, 01307
        • Local Institution
      • Frankfurt Am Main, Tyskland, 60590
        • Local Institution
      • Gauting, Tyskland, 82131
        • Local Institution
      • Grosshandsdorf, Tyskland, 22927
        • Local Institution
      • Hamburg, Tyskland, D-21075
        • Local Institution
      • Heidelberg, Tyskland, 69126
        • Local Institution
      • Kassel, Tyskland, 34125
        • Local Institution
      • Lubeck, Tyskland, 23538
        • Local Institution
      • Mainz, Tyskland, 55131
        • Local Institution
      • Muenchen, Tyskland, 81925
        • Local Institution
      • Neumunster, Tyskland, 24534
        • Local Institution
      • Nuernberg, Tyskland, 90419
        • Local Institution
      • Regensburg, Tyskland, 93049
        • Local Institution
      • Tuebingen, Tyskland, 72076
        • Local Institution
      • Ulm, Tyskland, 89081
        • Local Institution
      • Villingen-Schwenningen, Tyskland, 78052
        • Local Institution
  • Ungarn
      • Budapest, Ungarn, 1121
        • Local Institution
      • Budapest, Ungarn, 1125
        • Local Institution
      • Deszk, Ungarn, 6772
        • Local Institution
      • Farkasgyepu, Ungarn, 8582
        • Local Institution
      • Gyula, Ungarn, 5703
        • Local Institution
      • Matrahaza, Ungarn, 3233
        • Local Institution
      • Nyiregyhaza, Ungarn, 4400
        • Local Institution
      • Pecs, Ungarn, 7602
        • Local Institution
      • Sopron, Ungarn, 9400
        • Local Institution
      • Szekesfehervar, Ungarn, 8000
        • Local Institution
      • Szolnok, Ungarn, 5000
        • Local Institution
  • Østerrike
      • Graz, Østerrike, 8036
        • Local Institution
      • Linz, Østerrike, 4020
        • Local Institution
      • Salzburg, Østerrike, 5020
        • Local Institution

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: Ipilimumab
Andre navn:
  • BMS-734016
Legemiddel: Karboplatin
Andre navn:
  • Paraplatin®
Legemiddel: Paklitaksel
Andre navn:
  • 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
Legemiddel: Placebo
Legemiddel: Karboplatin
Andre navn:
  • Paraplatin®
Legemiddel: Paklitaksel
Andre navn:
  • Taxol®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. januar 2011

Primær fullføring (Faktiske)

9. juni 2015

Studiet fullført (Faktiske)

22. august 2017

Datoer for studieregistrering

Først innsendt

24. januar 2011

Først innsendt som oppfylte QC-kriteriene

27. januar 2011

Først lagt ut (Anslag)

28. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere