Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01285609
First received: January 24, 2011
Last updated: July 16, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Lung Cancer - Non Small Cell
Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) in Subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 48 months post study start ] [ Designated as safety issue: No ]

    Analysis will be conducted when the following 2 conditions have both been met:

    1. 518 OS events have been observed in randomized subjects treated with at least one dose of blinded study therapy and
    2. 705 OS events have been observed in all randomized subjects


Secondary Outcome Measures:
  • Overall Survival in all Randomized Subjects [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
  • Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]

Estimated Enrollment: 920
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BMS-734016
Drug: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®
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: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285609

  Hide Study Locations
Locations
United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Connecticut
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Florida
Local Institution
Boca Raton, Florida, United States, 33486
Local Institution
Jacksonville, Florida, United States, 32256
United States, Illinois
Quincy Medical Group
Quincy, Illinois, United States, 62301
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60076
Local Institution
Springfield, Illinois, United States, 62794
United States, Indiana
St. Francis Hospital & Health Centers
Indianapolis, Indiana, United States, 46237
Floyd Memorial Cancer Center Of Indiana
New Albany, Indiana, United States, 47150
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Montgomery Cancer Center
Mount Sterling, Kentucky, United States, 40353
United States, Michigan
Local Institution
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Kansas City Cancer Centers -South
Kansas City, Missouri, United States, 64131
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Clinical Research Alliance, Inc.
Lake Success, New York, United States, 11042
United States, North Carolina
Durham Va Medical Center (111g)
Durham, North Carolina, United States, 27705
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
Piedmont Hematology Oncology Associates, Pllc
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma Oncology And Hematology, Pc Dba
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Local Institution
Portland, Oregon, United States, 97227
United States, Pennsylvania
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Wjb Dorn Va Medical Center
Columbia, South Carolina, United States, 29209
Cancer Center Of The Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
United States, Texas
Texas Oncology, Pa - South Austin Cancer Center
Austin, Texas, United States, 78745
United States, Virginia
Blue Ridge Cancer Care
Christiansburg, Virginia, United States, 24073
Argentina
Local Institution
Quilmes, Buenos Aires, Argentina, B1878DVB
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Rosario, Santa Fe, Argentina, S2000DSV
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San Miguel De Tucuman, Tucuman, Argentina, 4000
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Cordoba, Argentina, X5006HBF
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Cordoba, Argentina, X5006IKK
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Santa Fe, Argentina, S3000FFU
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Frankston, Victoria, Australia, 3199
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Heidelberg, Victoria, Australia, 3084
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Wodonga, Victoria, Australia, 3690
Austria
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Linz, Dublin, Austria, 4020
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Graz, Metropolitana, Austria, 8036
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Salzburg, Metropolitana, Austria, 5020
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Linz, QC, Austria, 4020
Belgium
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Aalst, Sao Paulo, Belgium, 9300
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Yvoir, South Australia, Belgium, 5530
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Liege, Victoria, Belgium, 4000
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Sint Niklaas, Victoria, Belgium, 9100
Brazil
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Fortaleza, Ceara, Brazil, 60160
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Belo Horizonte, Parana, Brazil, 30150
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Curitiba, Parana, Brazil, 81520
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Passo Fundo, Rio Grande Do Sul, Brazil, 99010
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Barretos, Sao Paulo, Brazil, 14784
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Ribeirao Preto, Sao Paulo, Brazil, 14015
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Sao Jose dos Campos, Sao Paulo, Brazil, 12245
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Porto Alegre, South Australia, Brazil, 90430
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Rio de Janeiro, Valparaiso, Brazil, 20230
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Sao Paulo, Brazil, 01224
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Sao Paulo, Brazil, 04039
Canada, Quebec
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Montreal, Quebec, Canada, H2W 1S6
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Montreal, Quebec, Canada, H3T 1E2
Canada
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Oshawa, Canada, L1G 2B9
Chile
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Santiago, Metropolitana, Chile, 7520349
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Santiago, Metropolitana, Chile, 8380455
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Vina Del Mar, Valparaiso, Chile, 2540364
China, Guangdong
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Beijing, Guangdong, China, 100036
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Guangzhou, Guangdong, China, 510060
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Guanzhou, Guangdong, China, 510080
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Santiago, Guangdong, China, 7630370
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Shantou, Guangdong, China, 515041
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
China, Jilin
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Chang Chun, Jilin, China, 130012
China, Shaanxi
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Beijing, Shaanxi, China, 100853
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Seoul, Shaanxi, China, 710061
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Yokohama-Shi, Shaanxi, China, 710038
China, Xinjiang
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Urumqi, Xinjiang, China, 830011
China
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Beijing, China, 100071
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Beijing, China, 100032
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Nanjing, China, 210009
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Shanghai, China, 200030
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Shanghai, China, 200433
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Wuhan, China, 430023
Colombia
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Monteria, Cordoba, Colombia
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Pereira, Risaralda, Colombia
Czech Republic
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Prague 8 - Liben, Cordoba, Czech Republic, 180 81
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Praha 5, Okayama, Czech Republic, 150 06
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Prague 2, Osaka, Czech Republic, 12808
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Pribram V-Zdabor, Osaka, Czech Republic, 26195
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Znojmo, Osaka, Czech Republic, 669 02
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Ostrava, Poruba, Czech Republic, 70852
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Usti Nad Labem, Santa Fe, Czech Republic, 401 13
Denmark
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Herlev, Ceara, Denmark, 2730
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Aalborg, Metropolitana, Denmark, 9000
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Hillerod, Metropolitana, Denmark, 3400
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Naestved, QC, Denmark, 4700
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Odense, Victoria, Denmark, 5000
France
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Rennes, Cedex 09, France, 35033
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Caen, Madrid, France, 14076
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Poitiers, Metropolitana, France, 86000
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Marseille Cedex 20, NC, France, 13915
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Paris, NC, France, 75014
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Toulouse Cedex 9, NC, France, 31059
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Vandoeuvre-les-nancy, Western Cape, France, 54511
Germany
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Darmstadt, FL, Germany, 64283
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Dresden, Jilin, Germany, 01307
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Heidelberg, Metropolitana, Germany, 69126
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Ulm, Metropolitana, Germany, 89081
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Regensburg, Rio Grande Do Sul, Germany, 93049
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Bad Berka, Sao Paulo, Germany, 99437
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Bochum, Sao Paulo, Germany, 44791
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Frankfurt Am Main, Sao Paulo, Germany, 60590
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Gauting, Sao Paulo, Germany, 82131
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Grosshansdorf, Sao Paulo, Germany, 22927
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Hamburg, Sao Paulo, Germany, D-21075
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Kassel, Sao Paulo, Germany, 34125
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Lubeck, Sao Paulo, Germany, 23538
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Mainz, Sao Paulo, Germany, 55131
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Muenchen, Sao Paulo, Germany, 81925
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Neumunster, Sao Paulo, Germany, 24534
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Tuebingen, Tungpayathai, Germany, 72076
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Villingen, Valparaiso, Germany, 78050
Hong Kong
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Hong Kong, Cornwall, Hong Kong
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New Territories, South Yorkshire, Hong Kong, 8520
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Hong Kong, Vizcaya, Hong Kong, 8525
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Hong Kong, Vizcaya, Hong Kong
Hungary
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Budapest, Aichi, Hungary, 1125
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Matrahaza, Cedex 09, Hungary, 3233
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Pecs, Cordoba, Hungary, 7602
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Farkasgyepu, Cornwall, Hungary, 8582
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Budapest, Eastern Cape, Hungary, 1121
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Szekesfehervar, Guangdong, Hungary, 8000
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Nyiregyhaza, La Libertad, Hungary, 4400
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Sopron, La Libertad, Hungary, 9400
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Szolnok, La Libertad, Hungary, 5000
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Gyula, Lima, Hungary, 5703
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Deszk, Nottinghamshire, Hungary, 6772
Ireland
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Galway, Shaanxi Province, Ireland
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Dublin, Ireland, 24
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Dublin, Ireland, 4
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Dublin, Ireland, 8
Israel
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Haifa, Dublin, Israel, 31096
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Nahariya, Dublin, Israel, 22100
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Petah-Tikva, Dublin, Israel, 49100
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Rehovot, Dublin, Israel, 76100
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Tel-aviv, Dublin, Israel, 69710
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Zerifin, Dublin, Israel, 70300
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Beer Sheva, Kanagawa, Israel, 84101
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Jerusalem, Kanagawa, Israel, 91120
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Tel Aviv, Kanagawa, Israel, 64239
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Tel-hashomer, Shaanxi Province, Israel, 52621
Italy
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Treviglio, Cordoba, Italy, 24047
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Lucca, Dublin, Italy, 55100
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Monza, Dublin, Italy, 20052
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Sondrio, Dublin, Italy, 23100
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Terni, Dublin, Italy, 05100
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Padova, Kanagawa, Italy, 35128
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Bologna, La Libertad, Italy, 40138
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Lido Di Camaiore, La Libertad, Italy, 55041
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Benevento, Osaka, Italy, 82100
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Perugia, Osaka, Italy, 06156
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Siena, Osaka, Italy, 53100
Japan
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Nagoya, Aichi, Japan, 4648681
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Nagoya-shi, Aichi, Japan, 4600001
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Kashiwa, Chiba, Japan, 2778577
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Sapporo, Hokkaido, Chiba, Japan, 0030804
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Fukuoka-shi, Fukuoka, Japan, 8128582
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Osakasayama-city, Guangdong, Japan, 5898511
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Tokyo, Guangdong, Japan, 135-8550
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Kanazawa-shi, Ishikawa, Japan, 9208641
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Yokohama-Shi, Kanagawa, Japan, 2360051
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Yokohama-shi, Kanagawa, Japan, 2408555
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Sendai, Miyagi, Lima, Japan, 980-0873
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Matsuyama, Ehime, Metropolitana, Japan, 791-0280
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Natori-shi, Miyagi, Japan, 9811293
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Sendai, Miyagi, Japan, 9808574
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Kurashiki-shi, Okayama, Japan, 710-8602
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Kurashiki-shi, Okayama, Japan, 701-0182
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Hirakata-shi, Osaka, Japan, 5731191
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Osaka-shi, Osaka, Japan, 5340021
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Takatsuki, Osaka, Japan, 5698686
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Sapporo, Hokkaido, Risaralda, Japan, 0608648
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Akashi, Hyogo, Shizuoka, Japan, 6738558
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Sunto-gun, Shizuoka, Japan, 411-8777
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Ube-shi, Yamaguchi, Japan, 7550241
Korea, Republic of
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Seoul, Chiba, Korea, Republic of, 138-736
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Seoul, Cornwall, Korea, Republic of, 137-701
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Seoul, Cornwall, Korea, Republic of, 135-720
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Suwon, Gyeonggi-do, Korea, Republic of, 443-721
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Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
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Seoul, Kangnam-gu, Korea, Republic of, 135-710
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Seoul, Lima, Korea, Republic of, 134-791
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Daegu, Metropolitana, Korea, Republic of, 700-712
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Gyeonggi-do, Miyagi, Korea, Republic of, 463-802
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Seoul, Nottinghamshire, Korea, Republic of, 110-744
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Busan, NY, Korea, Republic of, 602-739
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Cheogju-si, OR, Korea, Republic of, 361-711
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Seoul, Seodaemungu, Korea, Republic of, 120-752
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Seoul, Seongbuk-gu, Korea, Republic of, 136-705
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Seoul, TN, Korea, Republic of, 156-755
Mexico
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Mexico, Distrito Federal, Mexico, 06760
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Zapopan, Jalisco, Mexico, 45170
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Monterrey, Nuevo Leon, Mexico, 64060
Netherlands
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Harderwijk, Gyeonggi-do, Netherlands, 3844 DG
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Nieuwegein, Gyeonggi-do, Netherlands, 3435 CM
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Breda, Nottinghamshire, Netherlands, 4818 CK
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Hertogenbosch, Nottinghamshire, Netherlands, 5223 GZ
Peru
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Trujillo, La Libertad, Peru
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Arequipa, Peru, AREQUIPA54
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Lima, Peru, LIMA 01
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Lima, Peru, LIMA 11
Poland
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Warsaw, Chiba, Poland, 02-781
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Szczecin, Metropolitana, Poland, 70-891
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Elblag, Nottinghamshire, Poland, 82-300
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Otwock, Nottinghamshire, Poland, 05-400
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Poznan, Nottinghamshire, Poland, 60 569
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Grudziadz, Nuevo Leon, Poland, 86-300
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Gdansk, Seodaemungu, Poland, 80-219
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Olsztyn, Seodaemungu, Poland, 10-357
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Torun, Yamaguchi, Poland, 87-100
Portugal
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Sao Martinho Do Bispo, Coimbra, Portugal, 3041801
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Vila Nova De Gaia, Nottinghamshire, Portugal, 4434-502
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Lisboa, Seodaemungu, Portugal, 1769-001
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Lisboa, Portugal, 1099023
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Porto, Portugal, 4200-072
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Santa Maria Da Feira, Portugal, 4520211
Romania
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Bucuresti, Gyeonggi-do, Romania, 010976
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Bucuresti, Gyeonggi-do, Romania, 300239
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Cluj Napoca, Gyeonggi-do, Romania, 400058
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Sibiu, Yamaguchi, Romania, 550245
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Suceava, Yamaguchi, Romania, 720237
Russian Federation
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Saint Petersburg, Coimbra, Russian Federation, 197758
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Kazan, Gyeonggi-do, Russian Federation, 420029
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Moscow, Gyeonggi-do, Russian Federation, 115478
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Tula, Gyeonggi-do, Russian Federation, 300053
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Chelyabinsk, Lisboa, Russian Federation, 454087
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Moscow, Lisboa, Russian Federation, 125009
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St. Petersburg, Nottinghamshire, Russian Federation, 197022
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Kazan, Nuevo Leon, Russian Federation, 420111
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Pyatigorsk, Nuevo Leon, Russian Federation, 357502
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St-Peterburg, Yamaguchi, Russian Federation, 198255
Singapore
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Singapore, Lisboa, Singapore, 308433
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Singapore, Nottinghamshire, Singapore, 258499
South Africa
Local Institution
Vereeniging, Eastern Cape, South Africa, 1900
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Durban, FL, South Africa, 4067
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Observatory, Western Cape, South Africa, 7925
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Panorama,cape Town, Western Cape, South Africa, 7500
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Rondebosch, Western Cape, South Africa, 7700
Spain
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Madrid, Ceara, Spain, 28041
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Ourense, IL, Spain, 32005
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Aalborg, Metropolitana, Spain, 05004
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Valencia, QC, Spain, 46014
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Benidorm-alicante, Sao Paulo, Spain, 03501
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Valencia, Sao Paulo, Spain, 46015
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Barakaldo, Vizcaya, Spain, 48903
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Castellon, Vizcaya, Spain, 12002
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Manresa, Vizcaya, Spain, 08243
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Madrid, Spain, 28033
Sweden
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Gothenburg, Coimbra, Sweden, 413 45
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Umea, Coimbra, Sweden, SE-901 85
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Lund, Nottinghamshire, Sweden, 221 85
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Stockholm, Nuevo Leon, Sweden, 17176
Switzerland
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Winterthur, Victoria, Switzerland, 8401
Taiwan
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Kaohsiung County, Coimbra, Taiwan, 83301
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Taichung, Coimbra, Taiwan, 404
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Taipei, Gyeonggi-do, Taiwan, 112
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Taoyuan County, Lisboa, Taiwan, 33305
Local Institution
Taichung, Nottinghamshire, Taiwan, 407.5
Local Institution
Changhua City, Seodaemungu, Taiwan, 500
Local Institution
Chiayi, Seodaemungu, Taiwan, 61363
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Taipei City, Yamaguchi, Taiwan, 10002
Thailand
Local Institution
Bangkok, Aichi, Thailand, 10700
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Bangkok, Cordoba, Thailand, 10400
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Bangkok, Lima, Thailand, 10330
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Chiang Mai, Santa Fe, Thailand, 50200
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Songkla, Santa Fe, Thailand, 90110
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Bangkok, Tungpayathai, Thailand, 10400
United Kingdom
Local Institution
Dundee, Angus/forfarshire, United Kingdom, DD1 9SY
Local Institution
Truro, Cornwall, United Kingdom, TR1 3LJ
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Southampton, Metropolitana, United Kingdom, SO16 6YD
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Nottingham, Nottinghamshire, United Kingdom, NG51PB
Local Institution
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01285609     History of Changes
Other Study ID Numbers: CA184-104, 2009-017396-19
Study First Received: January 24, 2011
Last Updated: July 16, 2015
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Federal Office of Public Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: CONEP
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
Denmark: Data inspectorate, Directorate for Health and Social Affairs
Finland: Finnish Medicines Agency
Norway: Directorate of Health
Sweden: Medical Products Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on August 02, 2015