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. (see Contacts and Locations)
Verified June 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: June 12, 2014
Last verified: June 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 (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
Estimated Primary Completion Date: October 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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, California
Sharp Clinical Oncology Research Active, not recruiting
San Diego, California, United States, 92123
United States, Florida
Local Institution Active, not recruiting
Boca Raton, Florida, United States, 33486
Local Institution Active, not recruiting
Jacksonville, Florida, United States, 32256
United States, Illinois
Quincy Medical Group Active, not recruiting
Quincy, Illinois, United States, 62301
Orchard Healthcare Research Inc. Active, not recruiting
Skokie, Illinois, United States, 60076
Local Institution Active, not recruiting
Springfield, Illinois, United States, 62794
United States, Indiana
St. Francis Hospital & Health Centers Active, not recruiting
Indianapolis, Indiana, United States, 46237
Floyd Memorial Cancer Center Of Indiana Active, not recruiting
New Albany, Indiana, United States, 47150
United States, Kentucky
Kentucky Cancer Clinic Active, not recruiting
Hazard, Kentucky, United States, 41701
Montgomery Cancer Center Active, not recruiting
Mount Sterling, Kentucky, United States, 40353
United States, Michigan
Local Institution Active, not recruiting
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Kansas City Cancer Centers -South Active, not recruiting
Kansas City, Missouri, United States, 64131
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Clinical Research Alliance, Inc. Active, not recruiting
Lake Success, New York, United States, 11042
United States, North Carolina
Durham Va Medical Center (111g) Active, not recruiting
Durham, North Carolina, United States, 27705
Carolina Biooncology Institute Active, not recruiting
Huntersville, North Carolina, United States, 28078
Piedmont Hematology Oncology Associates, Pllc Active, not recruiting
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center Research Active, not recruiting
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma Oncology And Hematology, Pc Dba Active, not recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Local Institution Active, not recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Guthrie Clinic, Ltd Active, not recruiting
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Local Institution Active, not recruiting
Columbia, South Carolina, United States, 29209
Cancer Center Of The Carolinas Active, not recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Tennessee Cancer Specialists Active, not recruiting
Knoxville, Tennessee, United States, 37909
United States, Texas
Texas Oncology, Pa - South Austin Cancer Center Active, not recruiting
Austin, Texas, United States, 78745
United States, Virginia
Blue Ridge Cancer Care Active, not recruiting
Christiansburg, Virginia, United States, 24073
Argentina
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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, X5006IKK
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Cordoba, Argentina, X5006HBF
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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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Heidelberg, Victoria, Australia, 3084
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Wodonga, Victoria, Australia, 3690
Austria
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Graz, Austria, 8036
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Linz, Austria, 4020
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Salzburg, Austria, 5020
Belgium
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Aalst, Belgium, 9300
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Liege, Belgium, 4000
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Sint Niklaas, Belgium, 9100
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Yvoir, Belgium, 5530
Brazil
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Fortaleza, Ceara, Brazil, 60160
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Belo Horizonte, Brazil, 30150
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Porto Alegre, Brazil, 90430
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Ribeirao Preto, Brazil, 14015
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Sao Paulo, Brazil, 01224
Canada, Quebec
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Montreal, Quebec, Canada, H2W 1S6
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Montreal, Quebec, Canada, H3T 1E2
Chile
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Santiago, Metropolitana, Chile, 8380455
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Santiago, Metropolitana, Chile, 7520349
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Vina Del Mar, Valparaiso, Chile, 2540364
Colombia
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Monteria, Cordoba, Colombia
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Pereira, Risaralda, Colombia
Czech Republic
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Ostrava, Poruba, Czech Republic, 70852
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Prague 2, Czech Republic, 12808
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Praha 5, Czech Republic, 150 06
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Pribram V-Zdabor, Czech Republic, 26195
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Usti Nad Labem, Czech Republic, 401 13
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Znojmo, Czech Republic, 669 02
Denmark
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Aalborg, Denmark, 9000
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Herlev, Denmark, 2730
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Hillerod, Denmark, 3400
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Odense, Denmark, 5000
France
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Rennes, Cedex 09, France, 35033
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Marseille Cedex 20, France, 13915
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Paris, France, 75014
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Poitiers, France, 86000
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Toulouse Cedex 9, France, 31059
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Vandoeuvre-les-nancy, France, 54511
Germany
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Bad Berka, Germany, 99437
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Bochum, Germany, 44791
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Gauting, Germany, 82131
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Grosshansdorf, Germany, 22927
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Hamburg, Germany, D-21075
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Heidelberg, Germany, 69126
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Kassel, Germany, 34125
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Lubeck, Germany, 23538
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Mainz, Germany, 55131
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Neumunster, Germany, 24534
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Regensburg, Germany, 93049
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Ulm, Germany, 89081
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Villingen, Germany, 78050
Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong, 8525
Hungary
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Budapest, Hungary, 1121
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Deszk, Hungary, 6772
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Matrahaza, Hungary, 3233
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Nyiregyhaza, Hungary, 4400
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Pecs, Hungary, 7602
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Sopron, Hungary, 9400
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Szekesfehervar, Hungary, 8000
Ireland
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Dublin, Ireland, 8
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Dublin, Ireland, 24
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Dublin, Ireland, 4
Israel
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Beer Sheva, Israel, 84101
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Nahariya, Israel, 22100
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Petah-Tikva, Israel, 49100
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Rehovot, Israel, 76100
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Tel-aviv, Israel, 64239
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Tel-aviv, Israel, 69710
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Zerifin, Israel, 70300
Italy
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Benevento, Italy, 82100
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Bologna, Italy, 40138
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Lido Di Camaiore, Italy, 55041
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Lucca, Italy, 55100
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Monza, Italy, 20052
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Padova, Italy, 35128
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Perugia, Italy, 06156
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Siena, Italy, 53100
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Sondrio, Italy, 23100
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Terni, Italy, 05100
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Treviglio, Italy, 24047
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 0348         
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Yokohama-shi, Kanagawa, Japan, 2408555
Contact: Site 0342         
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Yokohama-Shi, Kanagawa, Japan, 2360051
Contact: Site 0343         
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Natori-shi, Miyagi, Japan, 9811293
Contact: Site 0347         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0344         
Local Institution Recruiting
Ube-shi, Yamaguchi, Japan, 7550241
Contact: Site 0345         
Korea, Republic of
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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, Seodaemungu, Korea, Republic of, 120-752
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Seoul, Seongbuk-gu, Korea, Republic of, 136-705
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Cheogju-si, Korea, Republic of, 361-711
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Daegu, Korea, Republic of, 700-712
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Gyeonggi-do, Korea, Republic of, 463-802
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 137-701
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, Netherlands, 3844 DG
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Hertogenbosch, Netherlands, 5223 GZ
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Nieuwegein, Netherlands, 3435 CM
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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Elblag, Poland, 82-300
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Grudziadz, Poland, 86-300
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Olsztyn, Poland, 10-357
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Poznan, Poland, 60 569
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Szczecin, Poland, 70-891
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Warsaw, Poland, 02-781
Portugal
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Sao Martinho Do Bispo, Coimbra, Portugal, 3041801
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Lisboa, Portugal, 1769-001
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Santa Maria Da Feira, Portugal, 4520211
Romania
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Bucuresti, Romania, 010976
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Cluj Napoca, Romania, 400058
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Sibiu, Romania, 550245
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Suceava, Romania, 720237
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TimiB oara, Romania, 300239
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Kazan, Russian Federation, 420029
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Kazan, Russian Federation, 420111
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 125009
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Pyatigorsk, Russian Federation, 357502
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Saint Petersburg, Russian Federation, 197758
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Tula, Russian Federation, 300053
Singapore
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Singapore, Singapore, 308433
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Singapore, Singapore, 258499
South Africa
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Vereeniging, Eastern Cape, South Africa, 1900
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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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Barakaldo, Vizcaya, Spain, 48903
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Avila, Spain, 05004
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Benidorm-alicante, Spain, 03501
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Castellon, Spain, 12002
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Madrid, Spain, 28041
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Madrid, Spain, 28033
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Manresa, Spain, 08243
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Ourense, Spain, 32005
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Valencia, Spain, 46014
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Valencia, Spain, 46015
Sweden
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Gothenburg, Sweden, 413 45
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Lund, Sweden, 221 85
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Stockholm, Sweden, 17176
Switzerland
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Winterthur, Switzerland, 8401
Taiwan
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Chiayi, Taiwan, 61363
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Kaohsiung County, Taiwan, 83301
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Taichung, Taiwan, 404
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Taichung, Taiwan, 407.5
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Taipei, Taiwan, 112
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Taipei City, Taiwan, 10002
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Taoyuan County, Taiwan, 33305
Thailand
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Bangkok, Tungpayathai, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10400
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Chiang Mai, Thailand, 50200
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Songkla, Thailand, 90110
United Kingdom
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Dundee, Angus/forfarshire, United Kingdom, DD1 9SY
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Truro, Cornwall, United Kingdom, TR1 3LJ
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Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Local Institution Active, not recruiting
Southampton, United Kingdom, SO16 6YD
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: June 12, 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
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014