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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285609
First Posted: January 28, 2011
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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 Squamous Drug: Ipilimumab Drug: Placebo Drug: Paclitaxel Drug: Carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ]
    Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.


Secondary Outcome Measures:
  • Overall Survival (OS) in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start) ]
    Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.

  • Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ]
    Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.


Enrollment: 1289
Actual Study Start Date: January 16, 2011
Study Completion Date: August 22, 2017
Primary Completion Date: June 9, 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®

Detailed Description:
The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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) performance status of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285609


  Hide Study Locations
Locations
United States, California
Sharp Memorial Hospital
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
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Illinois
Quincy Medical Group
Quincy, Illinois, United States, 62301
Presence Medical Group Hematology Oncology
Skokie, Illinois, United States, 60076
Local Institution
Springfield, Illinois, United States, 62794-9678
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
University Of Kansas Cancer Center
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, 03756-0001
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
Novant Health Oncology Specialists
Lexington, North Carolina, United States, 27295
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, 74146
United States, Oregon
Local Institution
Portland, Oregon, United States, 97227
United States, Pennsylvania
Guthrie Medical Group, P.C.
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, 29615
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Thompson Oncology Group
Knoxville, Tennessee, United States, 37916
United States, Texas
Texas Oncology, PA - South Austin Cancer Center
Austin, Texas, United States, 78745
United States, Virginia
Blue Ridge Cancer Care
Blacksburg, Virginia, United States, 24060
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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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, 60160-230
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Belo Horizonte, Minas Gerais, Brazil, 30150-270
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Curitiba, Parana, Brazil, 81520-060
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Passo Fundo, RIO Grande DO SUL, Brazil, 99010260
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Barretos, SAO Paulo, Brazil, 14784
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Sao Jose dos Campos, SAO Paulo, Brazil, 12245
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Porto Alegre, Brazil, 90430
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Ribeirao Preto, Brazil, 14015
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Rio de Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 01224-010
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Sao Paulo, Brazil, 04039-901
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, 8380455
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Vina Del Mar, Valparaiso, Chile, 2540364
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Santiago, Chile, 7520378
China, Guangdong
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Guangzhou, Guangdong, China, 510060
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Guanzhou, Guangdong, China, 510080
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Shantou, Guangdong, China, 515041
China, Hubei
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Wuhan, Hubei, China, 430023
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
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Nanjing, Jiangsu, China, 210009
China, Jilin
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Changchun, Jilin, China, 130012
China, Shaanxi
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Xi'an, Shaanxi, China, 710038
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Xi'an, Shaanxi, China, 710061
China, Xinjiang
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Urumqi, Xinjiang, China, 830011
China
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Beijing, China, 100032
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Beijing, China, 100071
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Beijing, China, 100142
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Beijing, China, 100853
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Santiago, China, 7630370
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Shanghai, China, 200030
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Shanghai, China, 200433
Colombia
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Monteria, Cordoba, Colombia
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Pereira, Risaralda, Colombia
Czechia
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Ostrava, Poruba, Czechia, 70852
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Prague 2, Czechia, 12808
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Praha 5, Czechia, 150 06
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Praha 8, Czechia, 180 81
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Pribram V-Zdabor, Czechia, 26195
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Usti Nad Labem, Czechia, 401 13
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Znojmo, Czechia, 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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Naestved, Denmark, 4700
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Odense, Denmark, 5000
France
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Caen Cedex 05, France, 14076
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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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Rennes Cedex 9, France, 35033
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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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Darmstadt, Germany, 64283
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Dresden, Germany, 01307
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Frankfurt Am Main, Germany, 60590
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Gauting, Germany, 82131
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Grosshandsdorf, 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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Muenchen, Germany, 81925
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Neumunster, Germany, 24534
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Regensburg, Germany, 93049
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Tuebingen, Germany, 72076
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Ulm, Germany, 89081
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Villingen-Schwenningen, Germany, 78052
Hong Kong
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Hong Kong, Hong Kong, 8525
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Hong Kong, Hong Kong
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New Territories, Hong Kong, 8520
Hungary
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Budapest, Hungary, 1121
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Budapest, Hungary, 1125
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Deszk, Hungary, 6772
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Farkasgyepu, Hungary, 8582
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Gyula, Hungary, 5703
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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
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Szolnok, Hungary, 5000
Ireland
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Dublin, Ireland, 24
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Dublin, Ireland, 4
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Dublin, Ireland, 8
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Galway, Ireland
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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Tel-hashomer, Israel, 52621
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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
Nagoya-shi, Aichi, Japan, 4600001
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Nagoya, Aichi, Japan, 4648681
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Kashiwa, Chiba, Japan, 277-8577
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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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Natori-shi, Miyagi, Japan, 9811293
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Sendai, Miyagi, Japan, 9808574
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Kurashiki-shi, Okayama, Japan, 7010192
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Kurashiki-shi, Okayama, Japan, 710-8602
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Hirakata-shi, Osaka, Japan, 5731191
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Osaka-shi, Osaka, Japan, 5340021
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Sunto-gun, Shizuoka, Japan, 411-8777
Local Institution
Chuo-ku, Tokyo, Japan, 104-0045
Local Institution
Ube-shi, Yamaguchi, Japan, 7550241
Local Institution
Akashi, Hyogo, Japan, 6738558
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Fukuoka, Japan, 8128582
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Matsuyama, Ehime, Japan, 791-0280
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Osakasayama-city, Japan, 5898511
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Sapporo Hokkaido, Japan, 003-080
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Sapporo, Hokkaido, Japan, 0608648
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Sendai, Miyagi, Japan, 980-0873
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Takatsuki, Japan, 569-8686
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Tokyo, Japan, 135-8550
Korea, Republic of
Local Institution
Cheonju-si, Chungcheongbuk-do, Korea, Republic of, 361-771
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
Local Institution
Seoul, Kangnam-gu, Korea, Republic of, 135-710
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Seoul, Seodaemungu, Korea, Republic of, 120-752
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Busan, Korea, Republic of, 602-739
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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, 134-791
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 137-701
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 156-755
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Suwon, Korea, Republic of, 443-721
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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Breda, Netherlands, 4818 CK
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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
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Cercado, Peru
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Lima, Peru, LIMA 11
Poland
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Elblag, Poland, 82-300
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Gdansk- Zaspa, Poland, 80-462
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Gdansk, Poland, 80-952
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Grudziadz, Poland, 86-300
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Olsztyn, Poland, 10-357
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Otwock, Poland, 05-400
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Poznan, Poland, 60 569
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Szczecin, Poland, 70-891
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Torun, Poland, 87-100
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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, 1099023
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Lisboa, Portugal, 1769-001
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Porto, Portugal, 4200-072
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Santa Maria Da Feira, Portugal, 4520211
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Vila Nova De Gaia, Portugal, 4434-502
Romania
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Bucharest, Romania, 030171
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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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Timisoara, 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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St-Peterburg, Russian Federation, 198255
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St. Petersburg, Russian Federation, 197022
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Tula, Russian Federation, 300053
Singapore
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Singapore, Singapore, 258499
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Singapore, Singapore, 308433
South Africa
Local Institution
Vereeniging, Gauteng, South Africa, 1939
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Panorama,cape Town, Western CAPE, South Africa, 7500
Local Institution
Rondebosch, Western CAPE, South Africa, 7700
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Cape Town, South Africa, 7925
Local Institution
Durban, South Africa, 4067
Spain
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Barakaldo, Vizcaya, Spain, 48903
Local Institution
Benidorm-alicante, Spain, 03501
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Castellon, Spain, 12002
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Madrid, Spain, 28033
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Madrid, Spain, 28041
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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
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Ávila, Spain, 05004
Sweden
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Gothenburg, Sweden, 413 45
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Lund, Sweden, 221 85
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Stockholm, Sweden, 17176
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Umea, Sweden, SE-901 85
Switzerland
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Basel, Switzerland, 4031
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Winterthur, Switzerland, 8401
Taiwan
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Changhua City, Taiwan, 500
Local Institution
Chiayi, Taiwan, 61363
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Kaohsiung County, Taiwan, 83301
Local Institution
Taichung, Taiwan, 404
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Taichung, Taiwan, 407.5
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Taipei City, Taiwan, 100
Local Institution
Taipei, Taiwan, 112
Local Institution
Taipei, Taiwan
Thailand
Local Institution
Bangkok, Tungpayathai, Thailand, 10400
Local Institution
Bangkok, Thailand, 10330
Local Institution
Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
Local Institution
Songkhla, Thailand, 90110
United Kingdom
Local Institution
Dundee, Angus/forfarshire, United Kingdom, DD1 9SY
Local Institution
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institution
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution
Nottingham, United Kingdom, NG51PB
Local Institution
Sheffield, United Kingdom, s10 2SJ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01285609     History of Changes
Other Study ID Numbers: CA184-104
2009-017396-19 ( EudraCT Number )
First Submitted: January 24, 2011
First Posted: January 28, 2011
Results First Submitted: May 16, 2016
Results First Posted: June 23, 2016
Last Update Posted: December 13, 2017
Last Verified: November 2017

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
Albumin-Bound Paclitaxel
Carboplatin
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs