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

November 27, 2020 updated by: GlaxoSmithKline

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Quilmes, Argentina, 1878
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
      • Tucuman, Argentina, 4000
        • GSK Investigational Site
    • Buenos Aires
      • C.a.b.a., Buenos Aires, Argentina, C1425EHD
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430CLD
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
        • GSK Investigational Site
    • Córdova
      • Cordoba, Córdova, Argentina, X5000JFK
        • GSK Investigational Site
    • Río Negro
      • Cipolletti, Río Negro, Argentina, R8324EMB
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
        • GSK Investigational Site
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
      • Tweed Heads, New South Wales, Australia, 2485
        • GSK Investigational Site
      • Waratah, New South Wales, Australia, 2298
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • GSK Investigational Site
      • South Brisbane, Queensland, Australia, 4101
        • GSK Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Fitzroy, Victoria, Australia, 3065
        • GSK Investigational Site
      • Heidelberg, Victoria, Australia, 3084
        • GSK Investigational Site
      • Richmond, Victoria, Australia, 3121
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
      • Perth, Western Australia, Australia, 6001
        • GSK Investigational Site
  • Austria
      • Graz, Austria, A-8036
        • GSK Investigational Site
      • Innsbruck, Austria, 6020
        • GSK Investigational Site
      • Linz, Austria, A-4020
        • GSK Investigational Site
      • Linz, Austria, A-4010
        • GSK Investigational Site
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Vienna, Austria, A-1090
        • GSK Investigational Site
      • Vienna, Austria, 1130
        • GSK Investigational Site
      • Wels, Austria, A-4600
        • GSK Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • GSK Investigational Site
      • Brussels, Belgium, 1070
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Charleroi, Belgium, 6000
        • GSK Investigational Site
      • Duffel, Belgium, 2570
        • GSK Investigational Site
      • Edegem, Belgium, 2650
        • GSK Investigational Site
      • Genk, Belgium, 3600
        • GSK Investigational Site
      • Hasselt, Belgium, 3500
        • GSK Investigational Site
      • Jette, Belgium, 1090
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Namur, Belgium, 5000
        • GSK Investigational Site
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • GSK Investigational Site
      • São Paulo, Brazil, 01308-050
        • GSK Investigational Site
      • São Paulo, Brazil, 01509-900
        • GSK Investigational Site
      • São Paulo, Brazil, 01224-010
        • GSK Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30730-540
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
        • GSK Investigational Site
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • GSK Investigational Site
      • Santo André, São Paulo, Brazil, 09060-650
        • GSK Investigational Site
  • Canada
      • Québec, Canada, G1V 4G5
        • GSK Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • GSK Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1N1
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 2Y9
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • GSK Investigational Site
      • London, Ontario, Canada, N6A 5W9
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1P 2V5
        • GSK Investigational Site
      • St Catherines, Ontario, Canada, L2S 0A9
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4C 3E7
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6R 1B5
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4J 1C5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1T 2M4
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3T1E2
        • GSK Investigational Site
  • China
      • Beijing, China
        • GSK Investigational Site
      • Changsha, China
        • GSK Investigational Site
      • Guangzhou, China
        • GSK Investigational Site
      • Harbin, China
        • GSK Investigational Site
      • Shanghai, China, 200433
        • GSK Investigational Site
      • Shanghai, China, 200032
        • GSK Investigational Site
      • Shanghai, China, 200030
        • GSK Investigational Site
      • Tianjin, China, 300052
        • GSK Investigational Site
      • Wuhan, China
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • GSK Investigational Site
      • Guangzhou, Guangdong, China, 510120
        • GSK Investigational Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • GSK Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • GSK Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130012
        • GSK Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • GSK Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • GSK Investigational Site
      • Hangzhou, Zhejiang, China, 310022
        • GSK Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • GSK Investigational Site
      • Ostrava, Czechia, 708 52
        • GSK Investigational Site
      • Plzen, Czechia, 305 99
        • GSK Investigational Site
      • Praha 5, Czechia, 150 06
        • GSK Investigational Site
      • Praha 8, Czechia, 180 01
        • GSK Investigational Site
      • Usti nad Labem, Czechia, 401 12
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
      • Oulu, Finland, 90220
        • GSK Investigational Site
      • Tampere, Finland, 33520
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • 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, 59000
        • GSK Investigational Site
      • Lille, France, 59037
        • GSK Investigational Site
      • Limoges Cedex, France, 87042
        • GSK Investigational Site
      • Lorient cedex, France, 56322
        • GSK Investigational Site
      • Lyon, France, 69003
        • GSK Investigational Site
      • Lyon, France, 69365
        • 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, 75018
        • GSK Investigational Site
      • Paris, France, 75014
        • GSK Investigational Site
      • Paris, France, 75020
        • GSK Investigational Site
      • Paris Cedex 5, France, 75248
        • GSK Investigational Site
      • Paris cedex 20, France, 75970
        • 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
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 12351
        • GSK Investigational Site
      • Berlin, Germany, 12200
        • GSK Investigational Site
      • Bremen, Germany, 28325
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 21075
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69126
        • GSK Investigational Site
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • GSK Investigational Site
      • Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78050
        • GSK Investigational Site
      • Wangen, Baden-Wuerttemberg, Germany, 88239
        • GSK Investigational Site
    • Bayern
      • 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
    • Brandenburg
      • Frankfurt/Oder, Brandenburg, Germany, 15236
        • GSK Investigational Site
    • Hessen
      • 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
      • Fulda, Hessen, Germany, 36043
        • GSK Investigational Site
      • Immenhausen, Hessen, Germany, 34376
        • GSK Investigational Site
      • Offenbach, Hessen, Germany, 63069
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17487
        • GSK Investigational Site
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • GSK Investigational Site
    • Niedersachsen
      • 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
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
        • GSK Investigational Site
      • Bielefeld, Nordrhein-Westfalen, Germany, 33611
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • 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, 51109
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50931
        • GSK Investigational Site
      • Luedenscheid, Nordrhein-Westfalen, Germany, 58515
        • GSK Investigational Site
      • Moers, Nordrhein-Westfalen, Germany, 47441
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48153
        • GSK Investigational Site
      • Mulheim, Nordrhein-Westfalen, Germany, 45473
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germany, 41464
        • 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
      • Waldbrol, Nordrhein-Westfalen, Germany, 51545
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04129
        • GSK Investigational Site
      • Zwickau, Sachsen, Germany, 08058
        • GSK Investigational Site
    • Sachsen-Anhalt
      • 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
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • GSK Investigational Site
      • Kiel, Schleswig-Holstein, Germany, 24105
        • GSK Investigational Site
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • GSK Investigational Site
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 10676
        • GSK Investigational Site
      • Athens, Greece, 115 27
        • GSK Investigational Site
      • Athens, Greece, 11527
        • GSK Investigational Site
      • Athens, Greece, 11526
        • GSK Investigational Site
      • Athens, Greece, 145 64
        • GSK Investigational Site
      • Chania, Greece, 73100
        • GSK Investigational Site
      • Heraklion, 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, Greece, 57001
        • GSK Investigational Site
      • Thessaloniki, Greece, 57010
        • GSK Investigational Site
      • Thessaloniki, Greece, 540 07
        • GSK Investigational Site
  • Hong Kong
      • Kowloon, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary
        • GSK Investigational Site
      • Budapest, Hungary, 1529
        • 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
      • Pozva, Hungary, 8900
        • GSK Investigational Site
      • Pécs, Hungary, 7623
        • GSK Investigational Site
      • Szombathely, Hungary, 9700
        • GSK Investigational Site
      • Székesfehérvár, Hungary, 8000
        • GSK Investigational Site
  • India
      • Ahmedabad, 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, 400016
        • GSK Investigational Site
      • Mumbai, India, 400020
        • GSK Investigational Site
  • Ireland
      • Dublin, Ireland, 8
        • GSK Investigational Site
      • Dublin, Ireland, 9
        • GSK Investigational Site
      • Dublin, Ireland, 4
        • GSK Investigational Site
      • Galway, Ireland, Co Galway
        • GSK Investigational Site
  • Israel
      • 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
        • GSK Investigational Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • 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
    • Friuli-Venezia-Giulia
      • Udine, Friuli-Venezia-Giulia, Italy, 33100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00189
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00133
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00152
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
      • Genova, Liguria, Italy, 16149
        • GSK Investigational Site
    • Lombardia
      • 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
    • Piemonte
      • Novara, Piemonte, Italy, 28100
        • GSK Investigational Site
      • Orbassano (TO), Piemonte, Italy, 10043
        • GSK Investigational Site
      • Torino, Piemonte, Italy, 10126
        • GSK Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • GSK Investigational Site
    • Sardegna
      • Monserrato, Sardegna, Italy, 09042
        • GSK Investigational Site
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56124
        • GSK Investigational Site
      • Siena, Toscana, Italy, 53100
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06132
        • GSK Investigational Site
    • Veneto
      • Legnago, Veneto, Italy, 37045
        • GSK Investigational Site
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Japan
      • 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, 104-0045
        • GSK Investigational Site
      • Tokyo, Japan, 113-8431
        • GSK Investigational Site
      • Tokyo, Japan, 160-0023
        • GSK Investigational Site
  • Korea, Republic of
      • Kyunggi-do, Korea, Republic of, 410-769
        • GSK Investigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
  • Netherlands
      • 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
        • GSK Investigational Site
  • Norway
      • Oslo, Norway, 0407
        • GSK Investigational Site
      • Oslo, Norway, 0027
        • GSK Investigational Site
      • Trondheim, Norway, 7030
        • GSK Investigational Site
  • Poland
      • 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
        • GSK Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • GSK Investigational Site
      • Kazan, Russian Federation, 420029
        • GSK Investigational Site
      • Kursk, Russian Federation, 305035
        • GSK Investigational Site
      • Moscow, Russian Federation, 115478
        • GSK Investigational Site
      • Moscow, Russian Federation, 129128
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197 089
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • GSK Investigational Site
      • Stavropol, Russian Federation, 355047
        • GSK Investigational Site
      • Ufa,, Russian Federation, 450054
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • GSK Investigational Site
      • Singapore, Singapore, 169610
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Barcelona, Spain, 08221
        • GSK Investigational Site
      • Granada, Spain, 18014
        • GSK Investigational Site
      • Granada, Spain, 18013
        • GSK Investigational Site
      • Leganes, Spain, 28911
        • GSK Investigational Site
      • Lerida, Spain, 25198
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28050
        • GSK Investigational Site
      • Málaga, Spain, 29010
        • GSK Investigational Site
      • Oviedo, Spain, 33006
        • GSK Investigational Site
      • Sabadell, 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, 46010
        • GSK Investigational Site
      • Valencia, Spain, 46014
        • GSK Investigational Site
  • Sweden
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
  • Switzerland
      • 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
        • GSK Investigational Site
  • Taiwan
      • 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, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taoyuan, Taiwan, 333
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Bangkok, Thailand, 10110
        • GSK Investigational Site
      • Chiang Mai, Thailand, 50200
        • GSK Investigational Site
      • Hat yai, Thailand, 90110
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • GSK Investigational Site
      • Donetsk, Ukraine, 83092
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61070
        • GSK Investigational Site
      • Kyiv, Ukraine, 03115
        • GSK Investigational Site
      • Kyiv, Ukraine, 04107
        • 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
        • GSK Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • GSK Investigational Site
      • Bebington, 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 6NP
        • GSK Investigational Site
      • London, United Kingdom, SE1 9RT
        • GSK Investigational Site
      • London, United Kingdom, SW3 6JJ
        • GSK Investigational Site
      • Maidstone, United Kingdom, ME16 9QQ
        • GSK Investigational Site
      • Sheffield, United Kingdom, S10 2SJ
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2RE
        • GSK Investigational Site
    • Greater Manchester
      • Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • GSK Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36604
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85258
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85259
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • GSK Investigational Site
      • Fort Smith, Arkansas, United States, 72917
        • GSK Investigational Site
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Burbank, California, United States, 91505
        • GSK Investigational Site
      • Duarte, California, United States, 91010
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Greenbrae, California, United States, 94904-2007
        • GSK Investigational Site
      • La Jolla, California, United States, 92093
        • GSK Investigational Site
      • La Jolla, California, United States, 92093-0987
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
      • Montebello, California, United States, 90640
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
      • Palo Alto, California, United States, 94304
        • GSK Investigational Site
      • Pleasant Hill, California, United States, 94523
        • GSK Investigational Site
      • Rancho Mirage, California, United States, 92270
        • GSK Investigational Site
      • Sacramento, California, United States, 95816
        • GSK Investigational Site
      • Sacramento, California, United States, 95817
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Diego, California, United States, 92121
        • GSK Investigational Site
      • San Francisco, California, United States, 94107
        • GSK Investigational Site
      • Santa Rosa, California, United States, 95403-1757
        • GSK Investigational Site
      • Stanford, California, United States, 94305
        • GSK Investigational Site
      • Vallejo, California, United States, 94589
        • GSK Investigational Site
      • West Hollywood, California, United States, 90048
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • GSK Investigational Site
      • Torrington, Connecticut, United States, 06790
        • GSK Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
      • Boynton Beach, Florida, United States, 33435
        • GSK Investigational Site
      • Deerfield Beach, Florida, United States, 33064
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
      • Ocala, Florida, United States, 34474
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Stuart, Florida, United States, 34994
        • GSK Investigational Site
      • Tampa, Florida, United States, 33606
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • GSK Investigational Site
      • Athens, Georgia, United States, 30607
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30322
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30318
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30901
        • GSK Investigational Site
      • Macon, Georgia, United States, 31201
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31405
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • GSK Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Decatur, Illinois, United States, 62526
        • GSK Investigational Site
      • Evanston, Illinois, United States, 60201
        • GSK Investigational Site
      • Harvey, Illinois, United States, 60426
        • GSK Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • GSK Investigational Site
      • Peoria, Illinois, United States, 61615-7822
        • GSK Investigational Site
      • Springfield, Illinois, United States, 62794-9638
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
      • Indianapolis, Indiana, United States
        • GSK Investigational Site
      • Munster, Indiana, United States, 46321
        • GSK Investigational Site
      • New Albany, Indiana, United States, 47150
        • GSK Investigational Site
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • GSK Investigational Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • GSK Investigational Site
      • Hazard, Kentucky, United States, 41701
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40503
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40245
        • GSK Investigational Site
      • Owensboro, Kentucky, United States, 42303
        • GSK Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • GSK Investigational Site
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71101
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21237
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21204
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21215
        • GSK Investigational Site
      • Bethesda, Maryland, United States, 20892-1201
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20902
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02111
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • GSK Investigational Site
      • Bay City, Michigan, United States, 48706
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48201
        • GSK Investigational Site
      • Flint, Michigan, United States, 48503
        • GSK Investigational Site
      • Grand Rapids, Michigan, United States, 49503
        • GSK Investigational Site
      • Lansing, Michigan, United States, 48910
        • GSK Investigational Site
      • Lapeer, Michigan, United States, 48446
        • GSK Investigational Site
      • Southfield, Michigan, United States, 48075
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55407-3799
        • GSK Investigational Site
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
      • Saint Louis Park, Minnesota, United States, 55426
        • GSK Investigational Site
      • Saint Louis Park, Minnesota, United States, 55416
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64132
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • Springfield, Missouri, United States, 65804
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • GSK Investigational Site
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68114
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • GSK Investigational Site
      • Paramus, New Jersey, United States, 07652
        • GSK Investigational Site
    • New York
      • Armonk, New York, United States, 10504
        • GSK Investigational Site
      • Buffalo, New York, United States, 14263
        • GSK Investigational Site
      • East Syracuse, New York, United States, 13057
        • GSK Investigational Site
      • Flushing, New York, United States, 11355
        • GSK Investigational Site
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10065
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • New York, New York, United States, 10003
        • GSK Investigational Site
      • New York, New York, United States, 10011
        • GSK Investigational Site
      • New York, New York, United States, 10019
        • GSK Investigational Site
      • Syracuse, New York, United States, 13210
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7065
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28203
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27705
        • GSK Investigational Site
      • Greenville, North Carolina, United States, 27834
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
      • Canton, Ohio, United States, 44710
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45267
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43210
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45429
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • GSK Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • GSK Investigational Site
      • Portland, Oregon, United States, 97213
        • GSK Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • GSK Investigational Site
      • Danville, Pennsylvania, United States, 17822
        • GSK Investigational Site
      • Lancaster, Pennsylvania, United States, 17605
        • GSK Investigational Site
      • Langhorne, Pennsylvania, United States, 19047
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19111
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • GSK Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • GSK Investigational Site
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • GSK Investigational Site
      • Willow Grove, Pennsylvania, United States, 19090
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • GSK Investigational Site
      • Providence, Rhode Island, United States, 02903
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29414
        • GSK Investigational Site
      • Columbia, South Carolina, United States, 29209
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29615
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
      • Sumter, South Carolina, United States, 29150
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • GSK Investigational Site
      • Cookeville, Tennessee, United States, 38501
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37905
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38104
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Grapevine, Texas, United States, 76051
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Houston, Texas, United States, 77090
        • GSK Investigational Site
      • Round Rock, Texas, United States, 78665
        • GSK Investigational Site
      • Tyler, Texas, United States, 75708-3154
        • GSK Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • GSK Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • GSK Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • GSK Investigational Site
      • Roanoke, Virginia, United States, 24014
        • GSK Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • GSK Investigational Site
      • Seattle, Washington, United States, 98108
        • GSK Investigational Site
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site
      • Seattle, Washington, United States, 98109
        • GSK Investigational Site
      • Spokane, Washington, United States, 99208
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
      • Vancouver, Washington, United States, 98664
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53226
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSK1572932 Group
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
Placebo Comparator: Placebo Group
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Biological: Placebo Control
Intramuscular administration, 13 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
Time Frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
Time Frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
Time Frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
Time Frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
Time Frame: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Time Frame: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Time Frame: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >=/< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration >= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration >= 2 fold the pre-treatment antibody concentration.
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Time Frame: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies >= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Time Frame: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Health-related Quality of Life (HQL) Scores
Time Frame: At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).
At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
Time Frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Time Frame: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.
Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
Time Frame: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.
From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Collaborators and Investigators

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Sponsor

GlaxoSmithKline

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General Publications

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2007

Primary Completion (Actual)

December 6, 2013

Study Completion (Actual)

September 23, 2014

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

November 1, 2020

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109493
  • 2007-001283-73 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study is available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: 109493
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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