Lung Cancer Clinical Trial

Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

Summary

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Written informed consent (patient's written understanding of and agreement to participate in this study).
Patients with confirmed extensive small cell lung cancer (SCLC).
No prior chemotherapy within 5 years of the diagnosis of SCLC.
Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
Any active infection.
Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
Use of an investigational drug within 30 days before the first dose of study medication.
Women who are pregnant or lactating.
Patients of child-bearing potential who refuse to practice an adequate form of birth control.
Patients with clinical evidence of any stomach or intestinal (GI) condition.
Patients requiring treatment with the drug cyclosporin A.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

760

Study ID:

NCT00043927

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 169 Locations for this study

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GSK Clinical Trials Call Center
Hoover Alabama, 35216, United States
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Chula Vista California, 91911, United States
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Fountain Valley California, 92708, United States
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Greenbrae California, 94904, United States
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Poway California, 92064, United States
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Rancho Mirage California, 92270, United States
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Sacramento California, 95816, United States
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San Diego California, 92102, United States
GSK Clinical Trials Call Center
San Diego California, 92121, United States
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Soquel California, 95073, United States
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Vista California, 92083, United States
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Colorado Springs Colorado, 80909, United States
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Norwich Connecticut, 06360, United States
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Washington District of Columbia, 20307, United States
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Gainesville Florida, 32610, United States
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Miami Shores Florida, 33138, United States
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Ocala Florida, 34471, United States
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Pensacola Florida, 32501, United States
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Tarpon Springs Florida, 34689, United States
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Atlanta Georgia, 30030, United States
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Atlanta Georgia, 30308, United States
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Atlanta Georgia, 30328, United States
GSK Clinical Trials Call Center
Atlanta Georgia, 30335, United States
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Augusta Georgia, 30912, United States
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Cummings Georgia, 30040, United States
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Decatur Georgia, 30033, United States
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Aurora Illinois, 60506, United States
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Chicago Illinois, 60612, United States
GSK Clinical Trials Call Center
Chicago Illinois, 60637, United States
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Elk Grove Village Illinois, 60007, United States
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Park Ridge Illinois, 60068, United States
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Evansville Indiana, 47713, United States
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South Bend Indiana, 46601, United States
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New Orleans Louisiana, 70112, United States
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Shreveport Louisiana, 71103, United States
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Frederick Maryland, 21701, United States
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Pittsfield Massachusetts, 01201, United States
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Minneapolis Minnesota, 55404, United States
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St. Louis Missouri, 63141, United States
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Reno Nevada, 89502, United States
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Voorhees New Jersey, 08043, United States
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Albuquerque New Mexico, 87109, United States
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Albany New York, 12208, United States
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New York New York, 10021, United States
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New York New York, 10032, United States
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Rochester New York, 14623, United States
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Valhalla New York, 10595, United States
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Bismarck North Dakota, 58501, United States
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Cleveland Ohio, 44106, United States
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Columbus Ohio, 43222, United States
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Portland Oregon, 97232, United States
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Lemoyne Pennsylvania, 17043, United States
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Limerick Pennsylvania, 19468, United States
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Philadelphia Pennsylvania, 19140, United States
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Columbia South Carolina, 29203, United States
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Spartanburg South Carolina, 29303, United States
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Memphis Tennessee, 38119, United States
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Fort Worth Texas, 76104, United States
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Houston Texas, 77060, United States
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Abingdon Virginia, 24211, United States
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Norfolk Virginia, 23502, United States
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Olympia Washington, 98506, United States
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Yakima Washington, 98902, United States
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Morgantown West Virginia, 26506, United States
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Madison Wisconsin, 53792, United States
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Laramie Wyoming, 82070, United States
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Vienna , A-109, Austria
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Vienna , A-113, Austria
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Vienna , A-114, Austria
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Charleroi , 6000, Belgium
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Edegem , 2650, Belgium
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Haine-Saint- Paul , 7100, Belgium
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Leuven , 3000, Belgium
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Liege , 4000, Belgium
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Luxembourg , 1210, Belgium
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Belo Horizonte , 30140, Brazil
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Caxias do Sul , 95010, Brazil
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Fortaleza , 60430, Brazil
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Porto Alegre , 90020, Brazil
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Porto Alegre , 90035, Brazil
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Rio de Janeiro , 20230, Brazil
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Salvador , 41920, Brazil
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Sao Paulo , 04023, Brazil
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Sao Paulo , 05403, Brazil
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Bourgas , 8000, Bulgaria
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Plovdiv , 4000, Bulgaria
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Sofia , 1000/, Bulgaria
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Sofia , 1156, Bulgaria
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Varna , 9010, Bulgaria
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Winnipeg Manitoba, R3E 0, Canada
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Sydney Nova Scotia, B1P 1, Canada
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Newmarket Ontario, L3Y 2, Canada
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Oshawa Ontario, L1G 2, Canada
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Ottawa Ontario, K1H 1, Canada
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Peterborough Ontario, K9H 7, Canada
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Sault Sainte Marie Ontario, P6B 1, Canada
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Thunder Bay Ontario, P7B 6, Canada
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Toronto Ontario, M5G 2, Canada
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Weston Ontario, M9N 1, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H2L 4, Canada
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Montreal Quebec, H3T 1, Canada
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Sainte-Foy Quebec, G1V 4, Canada
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Santiago , , Chile
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Beijing , 10003, China
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Shanghai , 20043, China
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Wangfujing , 10073, China
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Xian , 71006, China
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San Jose , , Costa Rica
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Hradec Kralove , 500 0, Czech Republic
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Olomouc , 775 2, Czech Republic
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Plzen , 305 9, Czech Republic
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Praha , 121 0, Czech Republic
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Praha , 150 0, Czech Republic
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Tallinn , 11619, Estonia
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Helsinki , 29, Finland
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Kangasala , 36280, Finland
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Oulu , 90029, Finland
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Caen , 14076, France
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Calais Cedex , 62107, France
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Strasbourg , 67091, France
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Vesoul , 70014, France
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Heidelberg Baden-Wurttemberg, 69126, Germany
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Ebensfeld Bayern, 96250, Germany
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Gauting Bayern, 82131, Germany
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Grosshansdorf , 22927, Germany
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Tegucigalpa , , Honduras
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Budapest , 1529, Hungary
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Hungary , 8900, Hungary
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Genova Liguria, 16132, Italy
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Lazio , 149, Italy
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Roma , 149, Italy
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Roma , 184, Italy
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Kingston , , Jamaica
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Seoul , 110-7, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Kaunas , LT-45, Lithuania
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Vilnius , LT-08, Lithuania
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Chihuahua , 31000, Mexico
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Guadalajara , 44280, Mexico
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Guadalajara , 45170, Mexico
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Mexico City , 14000, Mexico
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Apeldoorn , 7334 , Netherlands
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Arnheim , 6815 , Netherlands
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Ede , 6716 , Netherlands
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Harderwijk , 3844 , Netherlands
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Nieuwegein , 3435 , Netherlands
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Hamilton , 2001, New Zealand
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Wellington South , 6002, New Zealand
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Oslo , 407, Norway
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Panama , , Panama
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Gdansk , 80-21, Poland
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Kielce , 25-64, Poland
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Ponce , 716, Puerto Rico
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Moscow Region , 143 4, Russian Federation
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Moscow , 107 0, Russian Federation
GSK Clinical Trials Call Center
Moscow , 115 4, Russian Federation
GSK Clinical Trials Call Center
Singapore , 11907, Singapore
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Banska Bystrica , 975 1, Slovakia
GSK Clinical Trials Call Center
Bratislava , 825 5, Slovakia
GSK Clinical Trials Call Center
Kosice , 041 0, Slovakia
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Nitra , 949 8, Slovakia
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Johannesburg Gauteng, 2193, South Africa
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Lerida , 25198, Spain
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Valencia , 46009, Spain
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Taipei , 100, Taiwan
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Taipei , 105, Taiwan
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Aberdeen Aberdeenshire, AB25 , United Kingdom
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Nottingham Nottinghamshire, NG5 1, United Kingdom
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Glasgow , G4 0S, United Kingdom
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Leeds , LS16 , United Kingdom
GSK Clinical Trials Call Center
Leicester , LE1 5, United Kingdom
GSK Clinical Trials Call Center
Poole , BH15 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

760

Study ID:

NCT00043927

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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