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GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00480025
First received: May 29, 2007
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Lung Cancer, Non-Small Cell
Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Biological: Placebo Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: At predefined time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]
  • Lung-cancer-specific survival [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]
  • Disease-free survival at 2, 3, 4 and 5 year [ Time Frame: After predifined time points ] [ Designated as safety issue: No ]
  • Disease-free specific survival [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]
  • Anti-MAGE-A3 and anti-protein D seropositivity rate. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]
  • Occurrence of adverse events, including abnormal hematological and biochemical parameters [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: At predifined time points ] [ Designated as safety issue: No ]

Enrollment: 2278
Study Start Date: October 2007
Estimated Study Completion Date: September 2022
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASCI Group
Not applicable
Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
Placebo Comparator: Placebo Group
Not applicable
Biological: Placebo Control
Intramuscular administration, 13 doses

Detailed Description:

"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic approach in an easy-to-understand format" "http://www.ascitrials.com gives practical information on the MAGRIT clinical study"

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
  • Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
  • Patient is ≥ 18 years of age at the time of signature of the first informed consent form.
  • The patient's tumor shows expression of MAGE-A3 gene
  • The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy;
  • The mediastinal lymph node sampling is done according to study protocol guidelines;
  • The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.

Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated.

  • ECOG performance status of 0, 1 or 2 at the time of randomization.
  • Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as:

Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)

≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN

  • If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion criteria

  • The primary tumor was removed by segmentectomy or wedge resection.
  • The patient shows any evidence of residual tumor after surgery.
  • The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:

For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.

  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  • The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
  • The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.

Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.

  • The patient has received a major organ allograft.
  • The patient is known to be HIV-positive.
  • The patient has an uncontrolled bleeding disorder.
  • The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
  • The patient needs home oxygenation.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  • The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
  • For female patients: the patient is pregnant or lactating.
  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: NCT00480025

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294-3300
GSK Investigational Site
Mobile, Alabama, United States, 36604
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85013
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Scottsdale, Arizona, United States, 85258
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Scottsdale, Arizona, United States, 85259
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Tucson, Arizona, United States, 85724
United States, Arkansas
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Fayetteville, Arkansas, United States, 72703
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Ft. Smith, Arkansas, United States, 72917
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Jonesboro, Arkansas, United States, 72401
United States, California
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Bakersfield, California, United States, 93309
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Beverly Hills, California, United States, 90211
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Burbank, California, United States, 91505
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Duarte, California, United States, 91010
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Fresno, California, United States, 93720
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Greenbrae, California, United States, 94904-2007
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La Jolla, California, United States, 92093-0987
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La Jolla, California, United States, 92093
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Los Angeles, California, United States, 90095
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Montebello, California, United States, 90640
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Orange, California, United States, 92868
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Palm Springs, California, United States, 92262
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Palo Alto, California, United States, 94304
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Pleasant Hill, California, United States, 94523
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Rancho Mirage, California, United States, 92270
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Sacramento, California, United States, 95817
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Sacramento, California, United States, 95816
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San Diego, California, United States, 92123
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San Diego, California, United States, 92121
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San Francisco, California, United States, 94107
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Santa Rosa, California, United States, 95403-1757
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Stanford, California, United States, 94305
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Vallejo, California, United States, 94589
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West Hollywood, California, United States, 90048
United States, Colorado
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Aurora, Colorado, United States, 80045
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Colorado Springs, Colorado, United States, 80907
United States, Connecticut
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Danbury, Connecticut, United States, 06810
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Torrington, Connecticut, United States, 06790
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Waterbury, Connecticut, United States, 06708
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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Boca Raton, Florida, United States, 33486
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Boynton Beach, Florida, United States, 33435
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Deerfield Beach, Florida, United States, 33064
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Fort Lauderdale, Florida, United States, 33316
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32209
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Ocala, Florida, United States, 34474
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Orlando, Florida, United States, 32804
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Orlando, Florida, United States, 32806
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Stuart, Florida, United States, 34994
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Tampa, Florida, United States, 33606
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Alpharetta, Georgia, United States, 30005
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Athens, Georgia, United States, 30607
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Atlanta, Georgia, United States, 30318
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30342
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Augusta, Georgia, United States, 30901
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Macon, Georgia, United States, 31201
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Marietta, Georgia, United States, 30060
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Savannah, Georgia, United States, 31405
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60611
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Decatur, Illinois, United States, 62526
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Evanston, Illinois, United States, 60201
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Harvey, Illinois, United States, 60426
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Park Ridge, Illinois, United States, 60068
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Peoria, Illinois, United States, 61615-7822
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Springfield, Illinois, United States, 62794-9638
United States, Indiana
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Evansville, Indiana, United States, 47713
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Indianapolis, Indiana, United States, 46260
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Indianapolis, Indiana, United States
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Munster, Indiana, United States, 46321
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New Albany, Indiana, United States, 47150
United States, Iowa
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Waterloo, Iowa, United States, 50701
United States, Kentucky
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Ashland, Kentucky, United States, 41101
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Hazard, Kentucky, United States, 41701
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Lexington, Kentucky, United States, 40503
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Louisville, Kentucky, United States, 40245
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Owensboro, Kentucky, United States, 42303
United States, Louisiana
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Alexandria, Louisiana, United States, 71301
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Metairie, Louisiana, United States, 70006
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Shreveport, Louisiana, United States, 71101
United States, Maryland
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Annapolis, Maryland, United States, 21401
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Baltimore, Maryland, United States, 21215
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Baltimore, Maryland, United States, 21201
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Baltimore, Maryland, United States, 21237
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Baltimore, Maryland, United States, 21204
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Bethesda, Maryland, United States, 20892-1201
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Silver Spring, Maryland, United States, 20902
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Towson, Maryland, United States, 21204
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
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Boston, Massachusetts, United States, 02118
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Boston, Massachusetts, United States, 02114
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Worcester, Massachusetts, United States, 01608
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Worcester, Massachusetts, United States, 01605
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
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Bay City, Michigan, United States, 48706
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Detroit, Michigan, United States, 48201
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Detroit, Michigan, United States, 48202
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Flint, Michigan, United States, 48503
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Grand Rapids, Michigan, United States, 49503
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Lansing, Michigan, United States, 48910
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Lapeer, Michigan, United States, 48446
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Southfield, Michigan, United States, 48075
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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Minneapolis, Minnesota, United States, 55407-3799
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Rochester, Minnesota, United States, 55905
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St. Louis Park, Minnesota, United States, 55416
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St. Louis Park, Minnesota, United States, 55426
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Kansas City, Missouri, United States, 64132
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Saint Louis, Missouri, United States, 63110
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Springfield, Missouri, United States, 65804
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St. Louis, Missouri, United States, 63110
United States, Montana
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Billings, Montana, United States, 59102
United States, Nebraska
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Grand Island, Nebraska, United States, 68803
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Omaha, Nebraska, United States, 68114
United States, Nevada
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Henderson, Nevada, United States, 89052
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New Jersey
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Long Branch, New Jersey, United States, 07740
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Paramus, New Jersey, United States, 07652
United States, New York
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Armonk, New York, United States, 10504
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Buffalo, New York, United States, 14263
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East Syracuse, New York, United States, 13057
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Flushing, New York, United States, 11355
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Mineola, New York, United States, 11501
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New York, New York, United States, 10003
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New York, New York, United States, 10011
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New York, New York, United States, 10065
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New York, New York, United States, 10019
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New York, New York, United States, 10016
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New York, New York, United States, 10032
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Syracuse, New York, United States, 13210
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599-7065
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Charlotte, North Carolina, United States, 28204
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Charlotte, North Carolina, United States, 28203
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Durham, North Carolina, United States, 27705
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Durham, North Carolina, United States, 27710
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Greenville, North Carolina, United States, 27834
United States, Ohio
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Akron, Ohio, United States, 44304
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Canton, Ohio, United States, 44710
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Cincinnati, Ohio, United States, 45242
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Cincinnati, Ohio, United States, 45267
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Columbus, Ohio, United States, 43210
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Dayton, Ohio, United States, 45429
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Bend, Oregon, United States, 97701
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Portland, Oregon, United States, 97213
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
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Danville, Pennsylvania, United States, 17822
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Lancaster, Pennsylvania, United States, 17605
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Langhorne, Pennsylvania, United States, 19047
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Philadelphia, Pennsylvania, United States, 19140
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19111
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Pittsburgh, Pennsylvania, United States, 15232
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Pittsburgh, Pennsylvania, United States, 15212
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Sayre, Pennsylvania, United States, 18840
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Wilkes-Barre, Pennsylvania, United States, 18702
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Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
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Providence, Rhode Island, United States, 02906
United States, South Carolina
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Charleston, South Carolina, United States, 29414
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29209
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Greenville, South Carolina, United States, 29615
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Spartanburg, South Carolina, United States, 29303
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Sumter, South Carolina, United States, 29150
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Cookeville, Tennessee, United States, 38501
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Knoxville, Tennessee, United States, 37905
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38120
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Memphis, Tennessee, United States, 38104
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Nashville, Tennessee, United States, 37203
United States, Texas
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Amarillo, Texas, United States, 79106
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75231
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Grapevine, Texas, United States, 76051
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Houston, Texas, United States, 77090
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Houston, Texas, United States, 77030
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Round Rock, Texas, United States, 78665
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Tyler, Texas, United States, 75708-3154
United States, Utah
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Ogden, Utah, United States, 84403
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Salt Lake City, Utah, United States, 84106
United States, Virginia
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Fairfax, Virginia, United States, 22031
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Roanoke, Virginia, United States, 24014
United States, Washington
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Everett, Washington, United States, 98201
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Seattle, Washington, United States, 98109
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98108
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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Vancouver, Washington, United States, 98664
United States, Wisconsin
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Madison, Wisconsin, United States, 53792
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Milwaukee, Wisconsin, United States, 53226
Argentina
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Berazategui, Buenos Aires, Argentina, B1880BBF
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C.a.b.a., Buenos Aires, Argentina, C1425EHD
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1185AAT
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430CLD
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Cordoba, Córdova, Argentina, X5000JFK
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Cipolletti, Río Negro, Argentina, R8324EMB
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Rosario, Santa Fe, Argentina, S2000KZE
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Quilmes, Argentina, 1878
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Santa Fe, Argentina, 3000
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Tucuman, Argentina, 4000
Australia, Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Tweed Heads, New South Wales, Australia, 2485
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Waratah, New South Wales, Australia, 2298
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Westmead, New South Wales, Australia, 2145
Australia, Queensland
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Chermside, Queensland, Australia, 4032
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South Brisbane, Queensland, Australia, 4101
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Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Fitzroy, Victoria, Australia, 3065
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Heidelberg, Victoria, Australia, 3084
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Richmond, Victoria, Australia, 3121
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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Perth, Western Australia, Australia, 6001
Austria
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Graz, Austria, A-8036
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Innsbruck, Austria, 6020
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Linz, Austria, A-4020
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Linz, Austria, A-4010
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Salzburg, Austria, A-5020
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Vienna, Austria, 1130
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Vienna, Austria, A-1090
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Wels, Austria, A-4600
Belgium
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Atwerpen, Belgium, 2020
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Brussels, Belgium, 1200
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Brussels, Belgium, 1070
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Charleroi, Belgium, 6000
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Duffel, Belgium, 2570
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Edegem, Belgium, 2650
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Genk, Belgium, 3600
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Hasselt, Belgium, 3500
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Jette, Belgium, 1090
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Namur, Belgium, 5000
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30730-540
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
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Barretos, São Paulo, Brazil, 14784-400
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Santo André, São Paulo, Brazil, 09060-650
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Sãp Paulo, São Paulo, Brazil, 01308-050
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Rio de Janeiro, Brazil, 20230-130
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São Paulo, Brazil, 01509-900
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São Paulo, Brazil, 01224-010
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Surrey, British Columbia, Canada, V3V 1N1
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 2Y9
Canada, Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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London, Ontario, Canada, N6A 5W9
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Newmarket, Ontario, Canada, L3Y 2P9
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Scarborough, Ontario, Canada, M1P 2V5
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St Catherines, Ontario, Canada, L2S 0A9
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Toronto, Ontario, Canada, M5G 1X5
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Toronto, Ontario, Canada, M4C 3E7
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Toronto, Ontario, Canada, M6R 1B5
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H3T1E2
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Québec, Quebec, Canada, G1V 4G5
China, Guangdong
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Guangzhou, Guangdong, China, 510120
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Guangzhou, Guangdong, China, 510060
China, Guangxi
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Nanning, Guangxi, China, 530021
China, Hubei
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Wuhan, Hubei, China, 430030
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
China, Jilin
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Changchun, Jilin, China, 130012
China, Sichuan
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Chengdu, Sichuan, China, 610041
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310022
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Harbin, China
GSK Investigational Site
Shanghai, China, 200030
GSK Investigational Site
Shanghai, China, 200032
GSK Investigational Site
Shanghai, China, 200433
GSK Investigational Site
Tianjin, China, 300052
GSK Investigational Site
Wuhan, China
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 625 00
GSK Investigational Site
Ostrava, Czech Republic, 708 52
GSK Investigational Site
Plzen, Czech Republic, 305 99
GSK Investigational Site
Praha 5, Czech Republic, 150 06
GSK Investigational Site
Praha 8, Czech Republic, 180 01
GSK Investigational Site
Usti nad Labem, Czech Republic, 401 12
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
Finland
GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Tampere, Finland, 33520
GSK Investigational Site
Turku, Finland, 20520
France
GSK Investigational Site
Angers cedex 9, France, 49933
GSK Investigational Site
Bayonne, France, 64100
GSK Investigational Site
Beauvais, France, 60021
GSK Investigational Site
Bethune Cedex, France, 62408
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Brest cedex, France, 29609
GSK Investigational Site
Bron, France, 69677
GSK Investigational Site
Caen, France, 14033
GSK Investigational Site
Elbeuf, France, 76503
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Lille, France, 59000
GSK Investigational Site
Limoges Cedex, France, 87042
GSK Investigational Site
Lorient cedex, France, 56322
GSK Investigational Site
Lyon, France, 69365
GSK Investigational Site
Lyon, France, 69003
GSK Investigational Site
Lyon cedex 08, France, 69373
GSK Investigational Site
Marseille cedex 20, France, 13915
GSK Investigational Site
Meaux, France, 77104
GSK Investigational Site
Metz, France, 57038
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Mulhouse Cedex, France, 68070
GSK Investigational Site
Nantes, France, 44202
GSK Investigational Site
Nice, France, 06002
GSK Investigational Site
Nîmes, France, 30029
GSK Investigational Site
Paris, France, 75020
GSK Investigational Site
Paris, France, 75014
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris cedex 20, France, 75970
GSK Investigational Site
Paris Cedex 5, France, 75248
GSK Investigational Site
Perpignan, France, 66000
GSK Investigational Site
Périgueux cedex, France, 24019
GSK Investigational Site
Reims, France, 51100
GSK Investigational Site
Rennes Cedex 09, France, 35033
GSK Investigational Site
Rouen, France, 76000
GSK Investigational Site
Saint Herblain, France, 44805
GSK Investigational Site
Saint-Priest en Jarez, France, 42271
GSK Investigational Site
Saint-Quentin, France, 02321
GSK Investigational Site
St Grégoire, France, 35768
GSK Investigational Site
Toulon cedex 09, France, 83041
GSK Investigational Site
Toulouse cedex 9, France, 31059
GSK Investigational Site
Vannes, France, 56017
GSK Investigational Site
Villefranche sur Saône, France, 69655
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78050
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
GSK Investigational Site
Augsburg, Bayern, Germany, 86156
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
GSK Investigational Site
Ebensfeld, Bayern, Germany, 96250
GSK Investigational Site
Gauting, Bayern, Germany, 82131
GSK Investigational Site
Muenchen, Bayern, Germany, 81925
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Regensburg, Bayern, Germany, 93049
GSK Investigational Site
Rosenheim, Bayern, Germany, 83022
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Frankfurt/Oder, Brandenburg, Germany, 15236
GSK Investigational Site
Darmstadt, Hessen, Germany, 64283
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Frankfurt, Hessen, Germany, 60488
GSK Investigational Site
Frankfurt/Main, Hessen, Germany, 60487
GSK Investigational Site
Immenhausen, Hessen, Germany, 34376
GSK Investigational Site
Offenbach, Hessen, Germany, 63069
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
GSK Investigational Site
Braunschweig, Niedersachsen, Germany, 38114
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Oldenburg, Niedersachsen, Germany, 26121
GSK Investigational Site
Ostercappeln, Niedersachsen, Germany, 49179
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33611
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33604
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44623
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50931
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
GSK Investigational Site
Luedenscheid, Nordrhein-Westfalen, Germany, 58515
GSK Investigational Site
Moers, Nordrhein-Westfalen, Germany, 47441
GSK Investigational Site
Muelheim, Nordrhein-Westfalen, Germany, 45473
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48153
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Troisdorf, Nordrhein-Westfalen, Germany, 53840
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Homburg, Saarland, Germany, 66421
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Halle (Saale), Sachsen-Anhalt, Germany, 06114
GSK Investigational Site
Weissenfels, Sachsen-Anhalt, Germany, 06667
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Leipzig, Sachsen, Germany, 04129
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
GSK Investigational Site
Berlin, Germany, 12200
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 12351
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Bremen, Germany, 28325
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 21075
Greece
GSK Investigational Site
Athens, Greece, 11526
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Athens, Greece, 145 64
GSK Investigational Site
Athens, Greece, 10676
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Chania, Greece, 73100
GSK Investigational Site
Heraklion, Crete, Greece, 71110
GSK Investigational Site
Larissa, Greece, 411 10
GSK Investigational Site
Marousi, Greece, 15125
GSK Investigational Site
Neo Faliro, Greece, 18547
GSK Investigational Site
Patra, Greece, 26500
GSK Investigational Site
Piraeus, Greece, 18537
GSK Investigational Site
Pylaia, Thessaloniki, Greece, 57001
GSK Investigational Site
Thessaloniki, Greece, 57010
GSK Investigational Site
Thessaloniki, Greece, 540 07
Hong Kong
GSK Investigational Site
Kowloon, Hong Kong
GSK Investigational Site
Shatin, N.T., Hong Kong
Hungary
GSK Investigational Site
Budapest, Hungary, 1529
GSK Investigational Site
Budapest, Hungary
GSK Investigational Site
Deszk, Hungary, 6772
GSK Investigational Site
Gyula, Hungary, 5703
GSK Investigational Site
Győr, Hungary, 9024
GSK Investigational Site
Miskolc, Hungary, 3529
GSK Investigational Site
Mátraháza, Hungary, 3233
GSK Investigational Site
Nyíregyháza, Hungary, 4400
GSK Investigational Site
Pécs, Hungary, 7623
GSK Investigational Site
Szombathely, Hungary, 9700
GSK Investigational Site
Székesfehérvár, Hungary, 8000
GSK Investigational Site
Zalaegerszeg-Pozva, Hungary, 8900
India
GSK Investigational Site
Ahemdabad, India, 380016
GSK Investigational Site
Ahmedabad, India, 380 009
GSK Investigational Site
Bangalore, India, 560029
GSK Investigational Site
Hyderabad, India, 500082
GSK Investigational Site
Mumbai, India, 400012
GSK Investigational Site
Mumbai, India, 400020
GSK Investigational Site
Mumbai, India, 400016
Ireland
GSK Investigational Site
Dublin, Ireland, 9
GSK Investigational Site
Dublin, Ireland, 8
GSK Investigational Site
Dublin, Ireland, 4
GSK Investigational Site
Galway, Ireland, Co Galway
Israel
GSK Investigational Site
Beer-Sheva, Israel, 84101
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Jerusalem, Israel, 91120
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Ramat Gan, Israel, 52621
GSK Investigational Site
Zrifin, Israel, 70300
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40139
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy, 47014
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy, 48100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
GSK Investigational Site
Roma, Lazio, Italy, 00189
GSK Investigational Site
Roma, Lazio, Italy, 00133
GSK Investigational Site
Roma, Lazio, Italy, 00152
GSK Investigational Site
Genova, Liguria, Italy, 16149
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Lecco, Lombardia, Italy, 23900
GSK Investigational Site
Milano, Lombardia, Italy, 20162
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Monza, Lombardia, Italy, 20052
GSK Investigational Site
Rozzano (MI), Lombardia, Italy, 20089
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
GSK Investigational Site
Torino, Piemonte, Italy, 10126
GSK Investigational Site
Bari, Puglia, Italy, 70124
GSK Investigational Site
Monserrato (CA), Sardegna, Italy, 09042
GSK Investigational Site
Palermo, Sicilia, Italy, 90146
GSK Investigational Site
Pisa, Toscana, Italy, 56124
GSK Investigational Site
Siena, Toscana, Italy, 53100
GSK Investigational Site
Perugia, Umbria, Italy, 06132
GSK Investigational Site
Legnago (VR), Veneto, Italy, 37045
GSK Investigational Site
Padova, Veneto, Italy, 35128
Japan
GSK Investigational Site
Aichi, Japan, 464-8681
GSK Investigational Site
Chiba, Japan, 277-8577
GSK Investigational Site
Ehime, Japan, 791-0280
GSK Investigational Site
Fukuoka, Japan, 811-1395
GSK Investigational Site
Fukuoka, Japan, 807-8555
GSK Investigational Site
Hiroshima, Japan, 730-8518
GSK Investigational Site
Hyogo, Japan, 673-8558
GSK Investigational Site
Kanagawa, Japan, 241-8515
GSK Investigational Site
Niigata, Japan, 951-8566
GSK Investigational Site
Osaka, Japan, 534-0021
GSK Investigational Site
Osaka, Japan, 537-8511
GSK Investigational Site
Shizuoka, Japan, 411-8777
GSK Investigational Site
Tokyo, Japan, 160-0023
GSK Investigational Site
Tokyo, Japan, 113-8431
GSK Investigational Site
Tokyo, Japan, 104-0045
Korea, Republic of
GSK Investigational Site
Kyunggi-do, Korea, Republic of, 410-769
GSK Investigational Site
Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
GSK Investigational Site
Heerlen, Netherlands, 6419 PC
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
Norway
GSK Investigational Site
Oslo, Norway, 0027
GSK Investigational Site
Oslo, Norway, 0407
GSK Investigational Site
Trondheim, Norway, 7030
Poland
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Bydgoszcz, Poland, 85-796
GSK Investigational Site
Bydgoszcz, Poland, 85-326
GSK Investigational Site
Checiny, Poland, 26-060
GSK Investigational Site
Gdansk, Poland, 80-952
GSK Investigational Site
Glucholazy, Poland, 41-340
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Lodz, Poland, 93-513
GSK Investigational Site
Lodz, Poland, 90-549
GSK Investigational Site
Lublin, Poland, 20-954
GSK Investigational Site
Poznan, Poland, 60-569
GSK Investigational Site
Rzeszow, Poland
GSK Investigational Site
Szczecin, Poland, 70-891
GSK Investigational Site
Warszawa, Poland, 04-125
GSK Investigational Site
Wroclaw, Poland, 53-439
GSK Investigational Site
Zakopane, Poland, 34-500
Russian Federation
GSK Investigational Site
Chelyabinsk, Russian Federation, 454087
GSK Investigational Site
Kazan, Russian Federation, 420029
GSK Investigational Site
Kursk, Russian Federation, 305035
GSK Investigational Site
Moscow, Russian Federation, 129 128
GSK Investigational Site
Moscow, Russian Federation, 115478
GSK Investigational Site
St. Petersburg, Russian Federation, 197 089
GSK Investigational Site
St. Petersburg, Russian Federation, 198255
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
GSK Investigational Site
Stavropol, Russian Federation, 355047
GSK Investigational Site
Ufa,, Russian Federation, 450054
Singapore
GSK Investigational Site
Singapore, Singapore, 169610
GSK Investigational Site
Singapore, Singapore, 119074
Spain
GSK Investigational Site
Barcelona, Spain, 08221
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Granada, Spain, 18013
GSK Investigational Site
Granada, Spain, 18014
GSK Investigational Site
Leganes, Spain, 28911
GSK Investigational Site
Lerida, Spain, 25198
GSK Investigational Site
Madrid, Spain, 28050
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Málaga, Spain, 29010
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
San Sebastian de los Reyes, Spain, 28702
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Valencia, Spain, 46014
GSK Investigational Site
Valencia, Spain, 46010
Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-171 76
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Switzerland
GSK Investigational Site
Aarau, Switzerland, 5001
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
Bruderholz, Switzerland, 4101
GSK Investigational Site
Thun, Switzerland, 3600
GSK Investigational Site
Zuerich, Switzerland, 8091
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 833
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taichung, Taiwan, 40705
GSK Investigational Site
Tainan, Taiwan, 704
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taoyuan County, Taiwan, 333
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10110
GSK Investigational Site
Chiang Mai, Thailand, 50200
GSK Investigational Site
Hatyai, Songkhla, Thailand, 90110
Ukraine
GSK Investigational Site
Dnipropetrovsk, Ukraine, 49102
GSK Investigational Site
Donetsk, Ukraine, 83092
GSK Investigational Site
Kharkiv, Ukraine, 61070
GSK Investigational Site
Kyiv, Ukraine, 04107
GSK Investigational Site
Kyiv, Ukraine, 03115
GSK Investigational Site
Kyiv, Ukraine, 01113
GSK Investigational Site
Lviv, Ukraine, 79031
GSK Investigational Site
Odesa, Ukraine, 65117
GSK Investigational Site
Simferopol, Ukraine, 95023
GSK Investigational Site
Uzhgorod, Ukraine, 88017
GSK Investigational Site
Vinnytsia, Ukraine, 21029
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2RE
GSK Investigational Site
Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Aberdeen, United Kingdom, AB25 2ZN
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
GSK Investigational Site
Belfast, United Kingdom, BT9 7AB
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
GSK Investigational Site
Cambridge, United Kingdom, CB23 3RE
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
GSK Investigational Site
Glasgow, United Kingdom, G12 0YN
GSK Investigational Site
Inverness, United Kingdom, IV2 3UJ
GSK Investigational Site
Leeds, United Kingdom, LS9 7TF
GSK Investigational Site
Liverpool, United Kingdom, L14 3PE
GSK Investigational Site
London, United Kingdom, SW3 6JJ
GSK Investigational Site
London, United Kingdom, SW3 6NP
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
Maidstone, United Kingdom, ME16 9QQ
GSK Investigational Site
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00480025     History of Changes
Obsolete Identifiers: NCT00638105
Other Study ID Numbers: 109493
Study First Received: May 29, 2007
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ASCI
Immunotherapeutic
MAGRIT
Tumor antigen
Non-small-cell lung cancer
Adjuvant cancer therapy

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

ClinicalTrials.gov processed this record on August 28, 2014