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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer - Non Small Cell Squamous
• Intervention / Treatment: Drug: Placebo; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 1289
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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
• Belgium
  • Aalst, Belgium, 9300
    • Local Institution
  • Liege, Belgium, 4000
    • Local Institution
  • Sint Niklaas, Belgium, 9100
    • Local Institution
  • Yvoir, Belgium, 5530
    • Local Institution
• Brazil
  • Porto Alegre, Brazil, 90430
    • Local Institution
  • Ribeirao Preto, Brazil, 14015
    • Local Institution
  • Rio de Janeiro, Brazil, 20231-050
    • Local Institution
  • Sao Paulo, Brazil, 01224-010
    • Local Institution
  • Sao Paulo, Brazil, 04039-901
    • Local Institution
  • Ceara
    • Fortaleza, Ceara, Brazil, 60160-230
      • Local Institution
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-270
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Local Institution
  • RIO Grande DO SUL
    • Passo Fundo, RIO Grande DO SUL, Brazil, 99010260
      • Local Institution
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil, 14784
      • Local Institution
    • Sao Jose dos Campos, SAO Paulo, Brazil, 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
• China
  • Beijing, China, 100032
    • Local Institution
  • Beijing, China, 100071
    • Local Institution
  • Beijing, China, 100142
    • Local Institution
  • Beijing, China, 100853
    • Local Institution
  • Santiago, China, 7630370
    • Local Institution
  • Shanghai, China, 200030
    • Local Institution
  • Shanghai, China, 200433
    • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Local Institution
    • Guanzhou, Guangdong, China, 510080
      • Local Institution
    • Shantou, Guangdong, China, 515041
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430023
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Local Institution
    • Nanjing, Jiangsu, China, 210009
      • Local Institution
    • Suzhou, Jiangsu, China, 215006
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Local Institution
    • Xi'an, Shaanxi, China, 710061
      • Local Institution
  • Xinjiang
    • Urumqi, Xinjiang, China, 830011
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution
• Colombia
  • Cordoba
    • Monteria, Cordoba, Colombia
      • Local Institution
  • Risaralda
    • Pereira, Risaralda, Colombia
      • Local Institution
• Czechia
  • Prague 2, Czechia, 12808
    • Local Institution
  • Praha 5, Czechia, 150 06
    • Local Institution
  • Praha 8, Czechia, 180 81
    • Local Institution
  • Pribram V-Zdabor, Czechia, 26195
    • Local Institution
  • Usti Nad Labem, Czechia, 401 13
    • Local Institution
  • Znojmo, Czechia, 669 02
    • Local Institution
  • Poruba
    • Ostrava, Poruba, Czechia, 70852
      • Local Institution
• Denmark
  • Aalborg, Denmark, 9000
    • Local Institution
  • Herlev, Denmark, 2730
    • Local Institution
  • Hillerod, Denmark, 3400
    • Local Institution
  • Naestved, Denmark, 4700
    • Local Institution
  • Odense, Denmark, 5000
    • Local Institution
• France
  • Caen Cedex 05, France, 14076
    • Local Institution
  • Marseille Cedex 20, France, 13915
    • Local Institution
  • Paris, France, 75014
    • Local Institution
  • Poitiers, France, 86000
    • Local Institution
  • Rennes Cedex 9, France, 35033
    • Local Institution
  • Toulouse Cedex 9, France, 31059
    • Local Institution
  • Vandoeuvre-les-nancy, France, 54511
    • Local Institution
• Germany
  • Bad Berka, Germany, 99437
    • Local Institution
  • Bochum, Germany, 44791
    • Local Institution
  • Darmstadt, Germany, 64283
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Frankfurt Am Main, Germany, 60590
    • Local Institution
  • Gauting, Germany, 82131
    • Local Institution
  • Grosshandsdorf, Germany, 22927
    • Local Institution
  • Hamburg, Germany, D-21075
    • Local Institution
  • Heidelberg, Germany, 69126
    • Local Institution
  • Kassel, Germany, 34125
    • Local Institution
  • Lubeck, Germany, 23538
    • Local Institution
  • Mainz, Germany, 55131
    • Local Institution
  • Muenchen, Germany, 81925
    • Local Institution
  • Neumunster, Germany, 24534
    • Local Institution
  • Nuernberg, Germany, 90419
    • Local Institution
  • Regensburg, Germany, 93049
    • Local Institution
  • Tuebingen, Germany, 72076
    • Local Institution
  • Ulm, Germany, 89081
    • Local Institution
  • Villingen-Schwenningen, Germany, 78052
    • Local Institution
• Hong Kong
  • Hong Kong, Hong Kong, 8525
    • Local Institution
  • Hong Kong, Hong Kong
    • Local Institution
  • New Territories, Hong Kong, 8520
    • Local Institution
• Hungary
  • Budapest, Hungary, 1121
    • Local Institution
  • Budapest, Hungary, 1125
    • Local Institution
  • Deszk, Hungary, 6772
    • Local Institution
  • Farkasgyepu, Hungary, 8582
    • Local Institution
  • Gyula, Hungary, 5703
    • Local Institution
  • Matrahaza, Hungary, 3233
    • Local Institution
  • Nyiregyhaza, Hungary, 4400
    • Local Institution
  • Pecs, Hungary, 7602
    • Local Institution
  • Sopron, Hungary, 9400
    • Local Institution
  • Szekesfehervar, Hungary, 8000
    • Local Institution
  • Szolnok, Hungary, 5000
    • Local Institution
• Ireland
  • Dublin, Ireland, 24
    • Local Institution
  • Dublin, Ireland, 4
    • Local Institution
  • Dublin, Ireland, 8
    • Local Institution
  • Galway, Ireland
    • 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
• Italy
  • Benevento, Italy, 82100
    • Local Institution
  • Bologna, Italy, 40138
    • Local Institution
  • Lido Di Camaiore, Italy, 55041
    • Local Institution
  • Lucca, Italy, 55100
    • Local Institution
  • Monza, Italy, 20052
    • Local Institution
  • Padova, Italy, 35128
    • Local Institution
  • Perugia, Italy, 06156
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
  • Sondrio, Italy, 23100
    • Local Institution
  • Terni, Italy, 05100
    • Local Institution
  • Treviglio, Italy, 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
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Local Institution
  • Daegu, Korea, Republic of, 700-712
    • Local Institution
  • Gyeonggi-do, Korea, Republic of, 463-802
    • Local Institution
  • Seoul, Korea, Republic of, 110-744
    • Local Institution
  • Seoul, Korea, Republic of, 138-736
    • Local Institution
  • Seoul, Korea, Republic of, 134-791
    • Local Institution
  • Seoul, Korea, Republic of, 135-720
    • Local Institution
  • Seoul, Korea, Republic of, 136-705
    • Local Institution
  • Seoul, Korea, Republic of, 137-701
    • Local Institution
  • Seoul, Korea, Republic of, 156-755
    • Local Institution
  • Suwon, Korea, Republic of, 443-721
    • Local Institution
  • Chungcheongbuk-do
    • Cheonju-si, Chungcheongbuk-do, Korea, Republic of, 361-771
      • Local Institution
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • Local Institution
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
      • Local Institution
  • Kangnam-gu
    • Seoul, Kangnam-gu, Korea, Republic of, 135-710
      • Local Institution
  • Seodaemungu
    • Seoul, Seodaemungu, Korea, Republic of, 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
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Local Institution
  • Harderwijk, Netherlands, 3844 DG
    • Local Institution
  • Hertogenbosch, Netherlands, 5223 GZ
    • Local Institution
  • Nieuwegein, Netherlands, 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
• Poland
  • Elblag, Poland, 82-300
    • Local Institution
  • Gdansk, Poland, 80-952
    • Local Institution
  • Gdansk- Zaspa, Poland, 80-462
    • Local Institution
  • Grudziadz, Poland, 86-300
    • Local Institution
  • Olsztyn, Poland, 10-357
    • Local Institution
  • Otwock, Poland, 05-400
    • Local Institution
  • Poznan, Poland, 60 569
    • Local Institution
  • Szczecin, Poland, 70-891
    • Local Institution
  • Torun, Poland, 87-100
    • Local Institution
  • Warsaw, Poland, 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
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Local Institution
  • Kazan, Russian Federation, 420029
    • Local Institution
  • Moscow, Russian Federation, 115478
    • Local Institution
  • Moscow, Russian Federation, 125009
    • Local Institution
  • Pyatigorsk, Russian Federation, 357502
    • Local Institution
  • Saint Petersburg, Russian Federation, 197758
    • Local Institution
  • St-Peterburg, Russian Federation, 198255
    • Local Institution
  • St. Petersburg, Russian Federation, 197022
    • Local Institution
  • Tula, Russian Federation, 300053
    • Local Institution
• Singapore
  • Singapore, Singapore, 308433
    • Local Institution
• South Africa
  • Cape Town, South Africa, 7925
    • Local Institution
  • Durban, South Africa, 4067
    • Local Institution
  • Gauteng
    • Vereeniging, Gauteng, South Africa, 1939
      • Local Institution
  • Western CAPE
    • Panorama,cape Town, Western CAPE, South Africa, 7500
      • Local Institution
• Spain
  • Avila, Spain, 05004
    • Local Institution
  • Benidorm-alicante, Spain, 03501
    • Local Institution
  • Castellon, Spain, 12002
    • Local Institution
  • Madrid, Spain, 28041
    • Local Institution
  • Madrid, Spain, 28033
    • Local Institution
  • Manresa, Spain, 08243
    • Local Institution
  • Ourense, Spain, 32005
    • Local Institution
  • Valencia, Spain, 46014
    • Local Institution
  • Valencia, Spain, 46015
    • Local Institution
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Local Institution
• Sweden
  • Gothenburg, Sweden, 413 45
    • Local Institution
  • Lund, Sweden, 221 85
    • Local Institution
  • Stockholm, Sweden, 17176
    • Local Institution
  • Umea, Sweden, SE-901 85
    • Local Institution
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution
  • Winterthur, Switzerland, 8401
    • 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
• United Kingdom
  • Nottingham, United Kingdom, NG51PB
    • Local Institution
  • Sheffield, United Kingdom, S10 2SJ
    • Local Institution
  • Angus/forfarshire
    • Dundee, Angus/forfarshire, United Kingdom, DD1 9SY
      • Local Institution
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Local Institution
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Local Institution
• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Lynn Cancer Institute Center For Hematology-Oncology
    • Jacksonville, Florida, United States, 32256
      • Integrated Community Oncology Network
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Medical Center
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Skokie, Illinois, United States, 60076
      • Presence Medical Group Hematology Oncology
    • Springfield, Illinois, United States, 62794-9678
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Hospital & Health Centers
    • New Albany, Indiana, United States, 47150
      • Floyd Memorial Cancer Center of Indiana
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St Joseph Mercy Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • University of Kansas Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Lake Success, New York, United States, 11042
      • Clinical Research Alliance, Inc.
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham Va Medical Center (111g)
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute
    • Lexington, North Carolina, United States, 27295
      • Novant Health Oncology Specialists
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Oncology And Hematology, Pc Dba
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest Region
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, P.C.
  • South Carolina
    • Columbia, South Carolina, United States, 29209
      • WJB Dorn VA Medical Center
    • Greenville, South Carolina, United States, 29615
      • Cancer Center Of The Carolinas
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Associated in Oncology and Hematology
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
    • Knoxville, Tennessee, United States, 37916
      • Thompson Oncology Group
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology, PA - South Austin Cancer Center
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Blue Ridge Cancer Care
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Wisconsin Institutes for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Ipilimumab; Other Names: BMS-734016; Drug: Carboplatin; Other Names: Paraplatin®; Drug: Paclitaxel; Other Names: Taxol®
Placebo Comparator: 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	Drug: Placebo; Drug: Carboplatin; Other Names: Paraplatin®; Drug: Paclitaxel; Other Names: Taxol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in All Randomized Participants at Primary Endpoint	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	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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2011
• Primary Completion (Actual): June 9, 2015
• Study Completion (Actual): August 22, 2017

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Carboplatin; Paclitaxel; Ipilimumab
• Other Study ID Numbers: CA184-104; 2009-017396-19 (EudraCT Number)