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

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01285609
First received: January 24, 2011
Last updated: January 23, 2014
Last verified: January 2014
  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 (defined as the time from the date of randomization until the date of death or the last known date the subject was alive) [ Time Frame: Approximately 48 months post study start ] [ Designated as safety issue: No ]
    Until 705 Death Events have occurred, Interim analysis at 528 events


Secondary Outcome Measures:
  • Overall Survival (OS) in subjects who receive one dose of blinded therapy [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
  • Progression Free Survival [determined as the time between the date of randomization and the date of progression per modified World Health Organization (mWHO) criteria] [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
  • Best Overall Response Rate (determined by the number of subjects who are complete or partial responders divided by the total number of subjects in the data set) [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]

Estimated Enrollment: 920
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone
Drug: Ipilimumab
IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks beginning at week 24
Other Name: BMS-734016
Drug: Paclitaxel
IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Other Name: Taxol®
Drug: Carboplatin
IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Other Name: Paraplatin®
Placebo Comparator: Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone
Drug: 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 beginning at week 24
Drug: Paclitaxel
IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Other Name: Taxol®
Drug: Carboplatin
IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285609

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: David Bodkin, Site 239    858-939-5062      
United States, Florida
Lynn Cancer Institute Center For Hematology-Oncology Recruiting
Boca Raton, Florida, United States, 33486
Contact: Teresa Decesare, Site 240    561-955-4800      
United States, Illinois
Quincy Medical Group Recruiting
Quincy, Illinois, United States, 62301
Contact: Christian El-Khoury, Site 241    217-222-6550      
Orchard Healthcare Research Inc. Recruiting
Skokie, Illinois, United States, 60077
Contact: Ira Anton Oliff, Site 015    224-534-7580      
Southern Illinois University School Of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: John Godwin, Site 012    217-524-0326      
United States, Indiana
St. Francis Hospital & Health Centers Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Michael Slaughter, Site 020         
Floyd Memorial Cancer Center Of Indiana Recruiting
New Albany, Indiana, United States, 47150
Contact: Naveed Chowhan, Site 226    812-945-4000      
United States, Kentucky
Kentucky Cancer Clinic Recruiting
Hazard, Kentucky, United States, 41701
Contact: Hassan H Ghazal, Site 007    606-439-2239      
Montgomery Cancer Center Recruiting
Mount Sterling, Kentucky, United States, 40353
Contact: Muhammad-Ali Zaydan, Site 199    334-273-2259      
United States, Michigan
St Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Philip Stella, Site 021    313-858-3000      
United States, Missouri
Kansas City Cancer Centers -South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Kelly Pendergrass, Site 017         
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Maria Baggstrom, Site 197    314-747-1217      
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: James Rigas, Site 019    603-650-6344      
United States, New York
Clinical Research Alliance, Inc. Recruiting
Lake Success, New York, United States, 11042
Contact: Francis P Arena, Site 223    516-466-6611      
United States, North Carolina
Durham Va Medical Center (111g) Recruiting
Durham, North Carolina, United States, 27705
Contact: Michael Kelley, Site 201    919-286-0411 ext X6072      
Carolina Biooncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: John D Powderly Ii,, Site 247    704-947-6599      
Piedmont Hematology Oncology Associates, Pllc Recruiting
Winston-salem, North Carolina, United States, 27103
Contact: Eugene H Paschold, Site 016    336-277-8814      
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Y Gabrail, Site 001    330-492-3345      
United States, Oklahoma
Oklahoma Oncology And Hematology, Pc Dba Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Steven C Buck, Site 002    918-292-8574      
United States, Oregon
Kaiser Permanente Northwest Region Recruiting
Portland, Oregon, United States, 97227
Contact: Mark Urban Rarick, Site 018    503-331-6570      
United States, Pennsylvania
Guthrie Clinic, Ltd Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Edward O'Brien, Site 014    570-882-4880      
United States, South Carolina
Wjb Dorn Va Medical Center Recruiting
Columbia, South Carolina, United States, 29209
Contact: Mohammed Wallam, Site 222         
Cancer Center Of The Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Gluck, Site 195    864-241-6251      
United States, Tennessee
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Tracy W Dobbs, Site 004    865-934-5818      
United States, Texas
Texas Oncology, Pa - South Austin Cancer Center Recruiting
Austin, Texas, United States, 78745
Contact: James Uyeki, Site 022         
United States, Virginia
Blue Ridge Cancer Care Recruiting
Christiansburg, Virginia, United States, 24073
Contact: Jerome H Goldschmidt, Jr., Site 008    540-982-1865 ext x116      
Argentina
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Rosario, Santa Fe, Argentina, S2000DSV
Contact: Site 080         
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San Miguel De Tucuman, Tucuman, Argentina, 4000
Contact: Site 079         
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Berazategui, Argentina, B1878DVB
Contact: Site 083         
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Cordoba, Argentina, X5006IKK
Contact: Site 082         
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Cordoba, Argentina, X5006HBF
Contact: Site 081         
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Santa Fe, Argentina, S3000FFU
Contact: Site 120         
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Contact: Site 186         
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
Contact: Site 187         
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Heidelberg, Victoria, Australia, 3084
Contact: Site 185         
Local Institution Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Site 188         
Austria
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Graz, Austria, 8036
Contact: Site 095         
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Linz, Austria, 4020
Contact: Site 093         
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Linz, Austria, 4020
Contact: Site 094         
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Salzburg, Austria, 5020
Contact: Site 092         
Belgium
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Aalst, Belgium, 9300
Contact: Site 193         
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Liege, Belgium, 4000
Contact: Site 224         
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Sint Niklaas, Belgium, 9100
Contact: Site 192         
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Yvoir, Belgium, 5530
Contact: Site 225         
Brazil
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Fortaleza, Ceara, Brazil, 60160-230
Contact: Site 134         
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Ribeirao Preto, Sao Paulo, Brazil, 14015
Contact: Site 136         
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Porto Alegre, Brazil, 90430
Contact: Site 133         
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Sao Paulo, Brazil, 01224
Contact: Site 130         
Canada, Quebec
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Montreal, Quebec, Canada, H3T 1E2
Contact: Site 025         
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Montreal, Quebec, Canada, H2W 1S6
Contact: Site 084         
Chile
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Santiago, Metropolitana, Chile, 8380455
Contact: Site 117         
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Santiago, Metropolitana, Chile, 7520349
Contact: Site 119         
Local Institution Recruiting
Vina Del Mar, Valparaiso, Chile, 2540364
Contact: Site 118         
Colombia
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Monteria, Cordoba, Colombia
Contact: Site 152         
Local Institution Not yet recruiting
Pereira, Risaralda, Colombia
Contact: Site 153         
Czech Republic
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Ostrava, Poruba, Czech Republic, 70852
Contact: Site 220         
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Prague 2, Czech Republic, 12808
Contact: Site 217         
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Praha 5, Czech Republic, 150 06
Contact: Site 218         
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Pribram V-Zdabor, Czech Republic, 26195
Contact: Site 260         
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Usti Nad Labem, Czech Republic, 401 13
Contact: Site 219         
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Znojmo, Czech Republic, 669 02
Contact: Site 221         
Denmark
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Aalborg, Denmark, 9000
Contact: Site 207         
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Herlev, Denmark, 2730
Contact: Site 059         
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Hillerod, Denmark, 3400
Contact: Site 058         
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Odense, Denmark, 5000
Contact: Site 060         
France
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Rennes, Cedex 09, France, 35033
Contact: Site 214         
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Marseille Cedex 20, France, 13915
Contact: Site 216         
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Paris, France, 75014
Contact: Site 210         
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Poitiers, France, 86000
Contact: Site 213         
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Toulouse Cedex 9, France, 31059
Contact: Site 215         
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Vandoeuvre-les-nancy, France, 54511
Contact: Site 211         
Germany
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Bad Berka, Germany, 99437
Contact: Site 096         
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Bochum, Germany, 44791
Contact: Site 099         
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Gauting, Germany, 82131
Contact: Site 098         
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Grosshansdorf, Germany, 22927
Contact: Site 161         
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Hamburg, Germany, D-21075
Contact: Site 158         
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Heidelberg, Germany, 69126
Contact: Site 103         
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Kassel, Germany, 34125
Contact: Site 160         
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Lubeck, Germany, 23538
Contact: Site 157         
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Mainz, Germany, 55131
Contact: Site 097         
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Neumunster, Germany, 24534
Contact: Site 159         
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Regensburg, Germany, 93049
Contact: Site 251         
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Ulm, Germany, 89081
Contact: Site 101         
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Villingen-Schwenningen, Germany, 78052
Contact: Site 100         
Hong Kong
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Hong Kong, Hong Kong, 8525
Contact: Site 029         
Local Institution Completed
Hong Kong, Hong Kong
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Hong Kong, Hong Kong
Contact: Site 031         
Hungary
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Budapest, Hungary, 1121
Contact: Site 073         
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Deszk, Hungary, 6772
Contact: Site 071         
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Matrahaza, Hungary, 3233
Contact: Site 069         
Local Institution Recruiting
Nyiregyhaza, Hungary, 4400
Contact: Site 074         
Local Institution Recruiting
Pecs, Hungary, 7602
Contact: Site 075         
Local Institution Recruiting
Sopron, Hungary, 9400
Contact: Site 076         
Local Institution Recruiting
Szekesfehervar, Hungary, H-8000
Contact: Site 077         
Ireland
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Dublin, Ireland, 8
Contact: Site 252         
Israel
Local Institution Recruiting
Beer Sheva, Israel, 84101
Contact: Site 042         
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Haifa, Israel, 31096
Contact: Site 039         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 040         
Local Institution Recruiting
Nahariya, Israel, 22100
Contact: Site 043         
Local Institution Recruiting
Petah-tikva, Israel, 49100
Contact: Site 041         
Local Institution Recruiting
Rehovot, Israel, 76100
Contact: Site 104         
Local Institution Recruiting
Tel-aviv, Israel, 69710
Contact: Site 174         
Local Institution Recruiting
Tel-aviv, Israel, 64239
Contact: Site 105         
Local Institution Recruiting
Tel-Hashomer, Israel, 52621
Contact: Site 037         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 038         
Italy
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Benevento, Italy, 82100
Contact: Site 045         
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 036         
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Lido Di Camaiore, Italy, 55041
Contact: Site 068         
Local Institution Recruiting
Lucca, Italy, 55100
Contact: Site 245         
Local Institution Recruiting
Monza, Italy, 20052
Contact: Site 050         
Local Institution Recruiting
Padova, Italy, 35128
Contact: Site 156         
Local Institution Recruiting
Perugia, Italy, 06156
Contact: Site 065         
Local Institution Recruiting
Siena, Italy, 53100
Contact: Site 057         
Local Institution Recruiting
Sondrio, Italy, 23100
Contact: Site 056         
Local Institution Recruiting
Terni, Italy, 05100
Contact: Site 268         
Local Institution Recruiting
Treviglio, Italy, 24047
Contact: Site 049         
Korea, Republic of
Local Institution Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Contact: Site 107         
Local Institution Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
Contact: Site 116         
Local Institution Recruiting
Seoul, Kangnam-gu, Korea, Republic of, 135-710
Contact: Site 114         
Local Institution Recruiting
Seoul, Seocho-gu, Korea, Republic of, 137-040
Contact: Site 109         
Local Institution Recruiting
Seoul, Seodaemungu, Korea, Republic of, 120-752
Contact: Site 113         
Local Institution Recruiting
Seoul, Seongbuk-gu, Korea, Republic of, 136-705
Contact: Site 112         
Local Institution Recruiting
Cheogju-si, Korea, Republic of, 361-711
Contact: Site 0290         
Local Institution Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Site 111         
Local Institution Recruiting
Gyeonggi-do, Korea, Republic of, 463-802
Contact: Site 108         
Local Institution Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Site 248         
Local Institution Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Site 110         
Local Institution Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Site 115         
Mexico
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 06760
Contact: Site 125         
Local Institution Recruiting
Zapopan, Jalisco, Mexico, 45170
Contact: Site 128         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64060
Contact: Site 127         
Netherlands
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Harderwijk, Netherlands, 3844 DG
Contact: Site 048         
Local Institution Recruiting
Hertogenbosch, Netherlands, 5223 GZ
Contact: Site 189         
Local Institution Recruiting
Nieuwegein, Netherlands, 3435 CM
Contact: Site 190         
Peru
Local Institution Recruiting
Trujillo, La Libertad, Peru
Contact: Site 121         
Local Institution Recruiting
Arequipa, Peru, AREQUIPA54
Contact: Site 124         
Local Institution Recruiting
Lima, Peru, LIMA 11
Contact: Site 122         
Poland
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Elblag, Poland, 82-300
Contact: Site 262         
Local Institution Recruiting
Olsztyn, Poland, 10-357
Contact: Site 170         
Local Institution Recruiting
Szczecin, Poland, 70-891
Contact: Site 172         
Portugal
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Sao Martinho Do Bispo, Coimbra, Portugal, 3041801
Contact: Site 232         
Local Institution Recruiting
Lisboa, Portugal, 1769-001
Contact: Site 230         
Local Institution Recruiting
Santa Maria Da Feira, Portugal, 4520211
Contact: Site 246         
Romania
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Bucuresti, Romania, 010976
Contact: Site 203         
Local Institution Recruiting
Cluj Napoca, Romania, 400058
Contact: Site 206         
Local Institution Recruiting
Sibiu, Romania, 550245
Contact: Site 205         
Local Institution Recruiting
Suceava, Romania, 720237
Contact: Site 202         
Local Institution Recruiting
TimiB oara, Romania, 300239
Contact: Site 204         
Russian Federation
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Chelyabinsk, Russian Federation, 454087
Contact: Site 253         
Local Institution Recruiting
Kazan, Russian Federation, 420029
Contact: Site 054         
Local Institution Recruiting
Moscow, Russian Federation, 115478
Contact: Site 061         
Local Institution Recruiting
Pyatigorsk, Russian Federation, 357502
Contact: Site 055         
Local Institution Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Site 257         
Local Institution Recruiting
Tula, Russian Federation, 300053
Contact: Site 256         
Singapore
Local Institution Recruiting
Singapore, Singapore, 308433
Contact: Site 026         
Local Institution Not yet recruiting
Singapore, Singapore, 258499
Contact: Site 027         
South Africa
Local Institution Recruiting
Vereeniging, Eastern Cape, South Africa, 1900
Contact: Site 052         
Local Institution Recruiting
Observatory, Western Cape, South Africa, 7925
Contact: Site 175         
Local Institution Recruiting
Panorama,cape Town, Western Cape, South Africa, 7500
Contact: Site 176         
Local Institution Not yet recruiting
Rondebosch, Western Cape, South Africa, 7700
Contact: Site 051         
Spain
Local Institution Recruiting
Barakaldo, Vizcaya, Spain, 48903
Contact: Site 090         
Local Institution Recruiting
Avila, Spain, 05004
Contact: Site 067         
Local Institution Recruiting
Benidorm-alicante, Spain, 03501
Contact: Site 089         
Local Institution Recruiting
Castellon, Spain, 12002
Contact: Site 091         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 066         
Local Institution Recruiting
Madrid, Spain, 28033
Contact: Site 180         
Local Institution Recruiting
Manresa, Spain, 08243
Contact: Site 249         
Local Institution Recruiting
Ourense, Spain, 32005
Contact: Site 178         
Local Institution Recruiting
Valencia, Spain, 46015
Contact: Site 087         
Local Institution Recruiting
Valencia, Spain, 46014
Contact: Site 088         
Sweden
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Gothenburg, Sweden, 413 45
Contact: Site 154         
Local Institution Recruiting
Stockholm, Sweden, 17176
Contact: Site 242         
Switzerland
Local Institution Recruiting
Winterthur, Switzerland, 8401
Contact: Site 238         
Taiwan
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Chiayi, Taiwan, 61363
Contact: Site 144         
Local Institution Recruiting
Kaohsiung County, Taiwan, 83301
Contact: Site 145         
Local Institution Recruiting
Taichung, Taiwan, 404
Contact: Site 147         
Local Institution Recruiting
Taichung, Taiwan, 407.5
Contact: Site 149         
Local Institution Recruiting
Taipei, Taiwan, 112
Contact: Site 150         
Local Institution Recruiting
Taipei City, Taiwan, 10002
Contact: Site 148         
Local Institution Recruiting
Taoyuan, Taiwan, 333
Contact: Site 146         
Thailand
Local Institution Recruiting
Bangkok, Tungpayathai, Thailand, 10400
Contact: Site 142         
Local Institution Recruiting
Bangkok, Thailand, 10330
Contact: Site 140         
Local Institution Recruiting
Bangkok, Thailand, 10400
Contact: Site 034         
Local Institution Recruiting
Bangkok, Thailand, 10700
Contact: Site 032         
Local Institution Recruiting
Chiang Mai, Thailand, 50200
Contact: Site 033         
Local Institution Recruiting
Songkla, Thailand, 90110
Contact: Site 181         
United Kingdom
Local Institution Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact: Site 272         
Local Institution Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Contact: Site 236         
Local Institution Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site 229         
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: January 23, 2014
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 15, 2014