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: October 13, 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 Recruiting
San Diego, California, United States, 92123
Contact: David Bodkin, Site 239    858-939-5052      
United States, Florida
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Site 240         
Local Institution Not yet recruiting
Jacksonville, Florida, United States, 32256
Contact: Site 276         
United States, Illinois
Quincy Medical Group Recruiting
Quincy, Illinois, United States, 62301
Contact: Christian El-Khoury, Site 241    217-277-3500 ext 7780      
Orchard Healthcare Research Inc. Recruiting
Skokie, Illinois, United States, 60076
Contact: Ira Anton Oliff, Site 015    224-534-7580      
Local Institution Not yet recruiting
Springfield, Illinois, United States, 62794
Contact: Site 012         
United States, Indiana
St. Francis Hospital & Health Centers Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Michael Slaughter, Site 020    317-528-7822      
Floyd Memorial Cancer Center Of Indiana Recruiting
New Albany, Indiana, United States, 47150
Contact: Yasoda Devabhaktuni, Site 226    812-945-4000 ext 113      
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    859-499-1000      
United States, Michigan
Local Institution Not yet recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Site 021         
United States, Missouri
Kansas City Cancer Centers -South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Kelly Pendergrass, Site 017    816-823-6641      
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Maria Baggstrom, Site 197    314-362-4140      
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: James Rigas, Site 019    603-650-5475      
United States, New York
Clinical Research Alliance, Inc. Recruiting
Lake Success, New York, United States, 11042
Contact: Francis P Arena, Site 223    855-737-2873      
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 7563      
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    336-277-8888      
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, 74104
Contact: Steven C Buck, Site 002    918-499-2000      
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97227
Contact: Site 018         
United States, Pennsylvania
Guthrie Clinic, Ltd Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Bradley Lash, Site 014    570-887-2141      
United States, South Carolina
Local Institution Not yet recruiting
Columbia, South Carolina, United States, 29209
Contact: Site 222         
Cancer Center Of The Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Gluck, Site 195    864-679-3926      
United States, Tennessee
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Tracy W Dobbs, Site 004    865-934-2672      
United States, Texas
Texas Oncology, Pa - South Austin Cancer Center Recruiting
Austin, Texas, United States, 78745
Contact: James Uyeki, Site 022    512-912-2761      
United States, Virginia
Blue Ridge Cancer Care Recruiting
Christiansburg, Virginia, United States, 24073
Contact: Jerome H Goldschmidt, Jr., Site 008         
Argentina
Local Institution Active, not recruiting
Quilmes, Buenos Aires, Argentina, B1878DVB
Local Institution Active, not recruiting
Rosario, Santa Fe, Argentina, S2000DSV
Local Institution Active, not recruiting
San Miguel De Tucuman, Tucuman, Argentina, 4000
Local Institution Not yet recruiting
Cordoba, Argentina, X5006IKK
Contact: Site 082         
Local Institution Active, not recruiting
Cordoba, Argentina, X5006HBF
Local Institution Active, not recruiting
Santa Fe, Argentina, S3000FFU
Australia, South Australia
Local Institution Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Site 186         
Australia, Victoria
Local Institution Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Site 187         
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 185         
Local Institution Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Site 188         
Austria
Local Institution Not yet recruiting
Graz, Austria, 8036
Contact: Site 095         
Local Institution Recruiting
Linz, Austria, 4020
Contact: Site 093         
Local Institution Recruiting
Linz, Austria, 4020
Contact: Site 094         
Local Institution Recruiting
Salzburg, Austria, 5020
Contact: Site 092         
Belgium
Local Institution Suspended
Aalst, Belgium, 9300
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 224         
Local Institution Recruiting
Sint Niklaas, Belgium, 9100
Contact: Site 192         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 225         
Brazil
Local Institution Recruiting
Fortaleza, Ceara, Brazil, 60160
Contact: Site 134         
Local Institution Recruiting
Belo Horizonte, Brazil, 30150
Contact: Site 131         
Local Institution Recruiting
Porto Alegre, Brazil, 90430
Contact: Site 133         
Local Institution Recruiting
Ribeirao Preto, Brazil, 14015
Contact: Site 136         
Local Institution Recruiting
Sao Paulo, Brazil, 01224
Contact: Site 130         
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Site 084         
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 025         
Chile
Local Institution Recruiting
Santiago, Metropolitana, Chile, 8380455
Contact: Site 117         
Local Institution Recruiting
Santiago, Metropolitana, Chile, 7520349
Contact: Site 119         
Local Institution Recruiting
Vina Del Mar, Valparaiso, Chile, 2540364
Contact: Site 118         
Colombia
Local Institution Recruiting
Monteria, Cordoba, Colombia
Contact: Site 152         
Local Institution Not yet recruiting
Pereira, Risaralda, Colombia
Contact: Site 153         
Czech Republic
Local Institution Recruiting
Ostrava, Poruba, Czech Republic, 70852
Contact: Site 220         
Local Institution Recruiting
Prague 2, Czech Republic, 12808
Contact: Site 217         
Local Institution Recruiting
Praha 5, Czech Republic, 150 06
Contact: Site 218         
Local Institution Recruiting
Pribram V-Zdabor, Czech Republic, 26195
Contact: Site 260         
Local Institution Recruiting
Usti Nad Labem, Czech Republic, 401 13
Contact: Site 219         
Local Institution Recruiting
Znojmo, Czech Republic, 669 02
Contact: Site 221         
Denmark
Local Institution Recruiting
Aalborg, Denmark, 9000
Contact: Site 207         
Local Institution Recruiting
Herlev, Denmark, 2730
Contact: Site 059         
Local Institution Recruiting
Hillerod, Denmark, 3400
Contact: Site 058         
Local Institution Recruiting
Odense, Denmark, 5000
Contact: Site 060         
France
Local Institution Recruiting
Rennes, Cedex 09, France, 35033
Contact: Site 214         
Local Institution Recruiting
Marseille Cedex 20, France, 13915
Contact: Site 216         
Local Institution Recruiting
Paris, France, 75014
Contact: Site 210         
Local Institution Recruiting
Poitiers, France, 86000
Contact: Site 213         
Local Institution Recruiting
Toulouse Cedex 9, France, 31059
Contact: Site 215         
Local Institution Recruiting
Vandoeuvre-les-nancy, France, 54511
Contact: Site 211         
Germany
Local Institution Recruiting
Bad Berka, Germany, 99437
Contact: Site 096         
Local Institution Recruiting
Bochum, Germany, 44791
Contact: Site 099         
Local Institution Active, not recruiting
Darmstadt, Germany, 64283
Local Institution Active, not recruiting
Dresden, Germany, 01307
Local Institution Recruiting
Gauting, Germany, 82131
Contact: Site 098         
Local Institution Recruiting
Grosshansdorf, Germany, 22927
Contact: Site 161         
Local Institution Not yet recruiting
Hamburg, Germany, D-21075
Contact: Site 158         
Local Institution Recruiting
Heidelberg, Germany, 69126
Contact: Site 103         
Local Institution Recruiting
Kassel, Germany, 34125
Contact: Site 160         
Local Institution Recruiting
Lubeck, Germany, 23538
Contact: Site 157         
Local Institution Recruiting
Mainz, Germany, 55131
Contact: Site 097         
Local Institution Recruiting
Neumunster, Germany, 24534
Contact: Site 159         
Local Institution Recruiting
Regensburg, Germany, 93049
Contact: Site 251         
Local Institution Recruiting
Ulm, Germany, 89081
Contact: Site 101         
Local Institution Not yet recruiting
Villingen, Germany, 78050
Contact: Site 100         
Hong Kong
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 031         
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 030         
Local Institution Not yet recruiting
Hong Kong, Hong Kong, 8525
Contact: Site 029         
Hungary
Local Institution Recruiting
Budapest, Hungary, 1121
Contact: Site 073         
Local Institution Recruiting
Deszk, Hungary, 6772
Contact: Site 071         
Local Institution Recruiting
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, 8000
Contact: Site 077         
Ireland
Local Institution Active, not recruiting
Dublin, Ireland, 4
Local Institution Recruiting
Dublin, Ireland, 8
Contact: Site 252         
Local Institution Not yet recruiting
Dublin, Ireland, 24
Contact: Site 254         
Israel
Local Institution Recruiting
Beer Sheva, Israel, 84101
Contact: Site 042         
Local Institution Not yet recruiting
Haifa, Israel, 31096
Contact: Site 039         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 040         
Local Institution Not yet 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 Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Site 105         
Local Institution Recruiting
Tel-aviv, Israel, 69710
Contact: Site 174         
Local Institution Recruiting
Tel-hashomer, Israel, 52621
Contact: Site 037         
Local Institution Not yet recruiting
Zerifin, Israel, 70300
Contact: Site 038         
Italy
Local Institution Recruiting
Benevento, Italy, 82100
Contact: Site 045         
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 036         
Local Institution Recruiting
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 Not yet 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         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 0348         
Local Institution Recruiting
Yokohama-Shi, Kanagawa, Japan, 2360051
Contact: Site 0343         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Contact: Site 0342         
Local Institution Recruiting
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
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, Seodaemungu, Korea, Republic of, 120-752
Contact: Site 113         
Local Institution Not yet 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         
Local Institution Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Site 109         
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
Local Institution Recruiting
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 Not yet recruiting
Trujillo, La Libertad, Peru
Contact: Site 121         
Local Institution Recruiting
Arequipa, Peru, AREQUIPA54
Contact: Site 124         
Local Institution Suspended
Lima, Peru, LIMA 01
Local Institution Recruiting
Lima, Peru, LIMA 11
Contact: Site 122         
Poland
Local Institution Recruiting
Elblag, Poland, 82-300
Contact: Site 262         
Local Institution Active, not recruiting
Gdansk, Poland, 80-219
Local Institution Suspended
Grudziadz, Poland, 86-300
Local Institution Recruiting
Olsztyn, Poland, 10-357
Contact: Site 170         
Local Institution Suspended
Poznan, Poland, 60 569
Local Institution Recruiting
Szczecin, Poland, 70-891
Contact: Site 172         
Local Institution Suspended
Warsaw, Poland, 02-781
Portugal
Local Institution Recruiting
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
Local Institution Recruiting
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
Local Institution Recruiting
Chelyabinsk, Russian Federation, 454087
Contact: Site 253         
Local Institution Recruiting
Kazan, Russian Federation, 420029
Contact: Site 054         
Local Institution Suspended
Kazan, Russian Federation, 420111
Local Institution Suspended
Moscow, Russian Federation, 125009
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 Not yet recruiting
Vereeniging, Eastern Cape, South Africa, 1900
Contact: Site 052         
Local Institution Recruiting
Observatory, Western Cape, South Africa, 7925
Contact: Site 175         
Local Institution Not yet 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         
Local Institution Not yet recruiting
Durban, South Africa, 4067
Contact: Site 047         
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 Not yet recruiting
Madrid, Spain, 28033
Contact: Site 180         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 066         
Local Institution Recruiting
Manresa, Spain, 08243
Contact: Site 249         
Local Institution Not yet recruiting
Ourense, Spain, 32005
Contact: Site 178         
Local Institution Recruiting
Valencia, Spain, 46014
Contact: Site 088         
Local Institution Not yet recruiting
Valencia, Spain, 46015
Contact: Site 087         
Sweden
Local Institution Recruiting
Gothenburg, Sweden, 413 45
Contact: Site 154         
Local Institution Recruiting
Lund, Sweden, 221 85
Contact: Site 155         
Local Institution Recruiting
Stockholm, Sweden, 17176
Contact: Site 242         
Switzerland
Local Institution Recruiting
Winterthur, Switzerland, 8401
Contact: Site 238         
Taiwan
Local Institution Not yet recruiting
Chiayi, Taiwan, 61363
Contact: Site 144         
Local Institution Recruiting
Kaohsiung County, Taiwan, 83301
Contact: Site 145         
Local Institution Recruiting
Taichung, Taiwan, 407.5
Contact: Site 149         
Local Institution Recruiting
Taichung, Taiwan, 404
Contact: Site 147         
Local Institution Recruiting
Taipei, Taiwan, 112
Contact: Site 150         
Local Institution Recruiting
Taipei City, Taiwan, 10002
Contact: Site 148         
Local Institution Recruiting
Taoyuan County, Taiwan, 33305
Contact: Site 146         
Thailand
Local Institution Recruiting
Bangkok, Tungpayathai, Thailand, 10400
Contact: Site 142         
Local Institution Recruiting
Bangkok, Thailand, 10700
Contact: Site 032         
Local Institution Not yet recruiting
Bangkok, Thailand, 10330
Contact: Site 140         
Local Institution Recruiting
Bangkok, Thailand, 10400
Contact: Site 034         
Local Institution Recruiting
Chiang Mai, Thailand, 50200
Contact: Site 033         
Local Institution Recruiting
Songkla, Thailand, 90110
Contact: Site 181         
United Kingdom
Local Institution Suspended
Dundee, Angus/forfarshire, United Kingdom, DD1 9SY
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: October 13, 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014