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

Lung Cancer, Non-Small Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00480025
• Other study ID #: 109493
• Secondary ID: 2007-001283-73
• Status: Terminated
• Phase: Phase 3
• Start date: October 4, 2007
• Est. completion date: September 23, 2014

Study information

• Verified date: November 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00638105

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2278
• Est. completion date: September 23, 2014
• Est. primary completion date: December 6, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Lung Neoplasms

Intervention

Biological:
• GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
• Placebo Control
Intramuscular administration, 13 doses

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	C.a.b.a.	Buenos Aires
Argentina	GSK Investigational Site	Cipolletti	Río Negro
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Quilmes
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Santa Fe
Argentina	GSK Investigational Site	Tucuman
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Chermside	Queensland
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	Nedlands	Western Australia
Australia	GSK Investigational Site	Perth	Western Australia
Australia	GSK Investigational Site	Richmond	Victoria
Australia	GSK Investigational Site	South Brisbane	Queensland
Australia	GSK Investigational Site	Tweed Heads	New South Wales
Australia	GSK Investigational Site	Waratah	New South Wales
Australia	GSK Investigational Site	Westmead	New South Wales
Australia	GSK Investigational Site	Woolloongabba	Queensland
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Wels
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Duffel
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Jette
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Namur
Brazil	GSK Investigational Site	Barretos	São Paulo
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Santo André	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Scarborough	Ontario
Canada	GSK Investigational Site	St Catherines	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Changchun	Jilin
China	GSK Investigational Site	Changsha
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Harbin
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Nanning	Guangxi
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Wuhan
China	GSK Investigational Site	Wuhan	Hubei
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Plzen
Czechia	GSK Investigational Site	Praha 5
Czechia	GSK Investigational Site	Praha 8
Czechia	GSK Investigational Site	Usti nad Labem
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Angers cedex 9
France	GSK Investigational Site	Bayonne
France	GSK Investigational Site	Beauvais
France	GSK Investigational Site	Bethune Cedex
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Brest cedex
France	GSK Investigational Site	Bron
France	GSK Investigational Site	Caen
France	GSK Investigational Site	Elbeuf
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Limoges Cedex
France	GSK Investigational Site	Lorient cedex
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Lyon cedex 08
France	GSK Investigational Site	Marseille cedex 20
France	GSK Investigational Site	Meaux
France	GSK Investigational Site	Metz
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Mulhouse Cedex
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Nîmes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris cedex 20
France	GSK Investigational Site	Paris Cedex 5
France	GSK Investigational Site	Périgueux cedex
France	GSK Investigational Site	Perpignan
France	GSK Investigational Site	Reims
France	GSK Investigational Site	Rennes Cedex 09
France	GSK Investigational Site	Rouen
France	GSK Investigational Site	Saint Herblain
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Saint-Quentin
France	GSK Investigational Site	St Grégoire
France	GSK Investigational Site	Toulon cedex 09
France	GSK Investigational Site	Toulouse cedex 9
France	GSK Investigational Site	Vannes
France	GSK Investigational Site	Villefranche sur Saône
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Berka	Thueringen
Germany	GSK Investigational Site	Bayreuth	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Braunschweig	Niedersachsen
Germany	GSK Investigational Site	Bremen
Germany	GSK Investigational Site	Darmstadt	Hessen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Ebensfeld	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt/Main	Hessen
Germany	GSK Investigational Site	Frankfurt/Oder	Brandenburg
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Fulda	Hessen
Germany	GSK Investigational Site	Gauting	Bayern
Germany	GSK Investigational Site	Greifswald	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Halle (Saale)	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hemer	Nordrhein-Westfalen
Germany	GSK Investigational Site	Herne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Homburg	Saarland
Germany	GSK Investigational Site	Immenhausen	Hessen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Luedenscheid	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Moers	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mulheim	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Oldenburg	Niedersachsen
Germany	GSK Investigational Site	Ostercappeln	Niedersachsen
Germany	GSK Investigational Site	Porta Westfalica	Nordrhein-Westfalen
Germany	GSK Investigational Site	Regensburg	Bayern
Germany	GSK Investigational Site	Regensburg	Bayern
Germany	GSK Investigational Site	Rosenheim	Bayern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Troisdorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Velbert	Nordrhein-Westfalen
Germany	GSK Investigational Site	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Waldbrol	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weissenfels	Sachsen-Anhalt
Germany	GSK Investigational Site	Wuerzburg	Bayern
Germany	GSK Investigational Site	Zwickau	Sachsen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Chania
Greece	GSK Investigational Site	Heraklion
Greece	GSK Investigational Site	Larissa
Greece	GSK Investigational Site	Marousi
Greece	GSK Investigational Site	Neo Faliro
Greece	GSK Investigational Site	Patra
Greece	GSK Investigational Site	Piraeus
Greece	GSK Investigational Site	Pylaia
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Kowloon
Hong Kong	GSK Investigational Site	Shatin
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Deszk
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Mátraháza
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Nyíregyháza
Hungary	GSK Investigational Site	Pécs
Hungary	GSK Investigational Site	Pozva
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szombathely
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	Mumbai
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Galway
Israel	GSK Investigational Site	Beer-Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Ramat Gan
Israel	GSK Investigational Site	Zrifin
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Lecco	Lombardia
Italy	GSK Investigational Site	Legnago	Veneto
Italy	GSK Investigational Site	Meldola (FC)	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Monserrato	Sardegna
Italy	GSK Investigational Site	Monza	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Novara	Piemonte
Italy	GSK Investigational Site	Orbassano (TO)	Piemonte
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Ravenna	Emilia-Romagna
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	Siena	Toscana
Italy	GSK Investigational Site	Torino	Piemonte
Italy	GSK Investigational Site	Udine	Friuli-Venezia-Giulia
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Ehime
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Kyunggi-do
Korea, Republic of	GSK Investigational Site	Seongnam-si
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Nieuwegein
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Trondheim
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Checiny
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Glucholazy
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Rzeszow
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zakopane
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Kursk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Stavropol
Russian Federation	GSK Investigational Site	Ufa,
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Leganes
Spain	GSK Investigational Site	Lerida
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Sabadell
Spain	GSK Investigational Site	San Sebastian de los Reyes
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Switzerland	GSK Investigational Site	Aarau
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Bruderholz
Switzerland	GSK Investigational Site	Thun
Switzerland	GSK Investigational Site	Zuerich
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiang Mai
Thailand	GSK Investigational Site	Hat yai
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lviv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Uzhgorod
Ukraine	GSK Investigational Site	Vinnytsia
United Kingdom	GSK Investigational Site	Aberdeen
United Kingdom	GSK Investigational Site	Bebington
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Cambridge
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Glasgow
United Kingdom	GSK Investigational Site	Inverness
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Maidstone
United Kingdom	GSK Investigational Site	Sheffield
United Kingdom	GSK Investigational Site	Sutton	Surrey
United Kingdom	GSK Investigational Site	Wythenshawe	Greater Manchester
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Alpharetta	Georgia
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Annapolis	Maryland
United States	GSK Investigational Site	Armonk	New York
United States	GSK Investigational Site	Ashland	Kentucky
United States	GSK Investigational Site	Athens	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bay City	Michigan
United States	GSK Investigational Site	Bend	Oregon
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Bethlehem	Pennsylvania
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Cookeville	Tennessee
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danbury	Connecticut
United States	GSK Investigational Site	Danville	Pennsylvania
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Decatur	Illinois
United States	GSK Investigational Site	Deerfield Beach	Florida
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Duarte	California
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	East Syracuse	New York
United States	GSK Investigational Site	Evanston	Illinois
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Everett	Washington
United States	GSK Investigational Site	Fairfax	Virginia
United States	GSK Investigational Site	Fayetteville	Arkansas
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Flushing	New York
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Smith	Arkansas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Grand Island	Nebraska
United States	GSK Investigational Site	Grand Rapids	Michigan
United States	GSK Investigational Site	Grapevine	Texas
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Harvey	Illinois
United States	GSK Investigational Site	Hazard	Kentucky
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lancaster	Pennsylvania
United States	GSK Investigational Site	Langhorne	Pennsylvania
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Lapeer	Michigan
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Long Branch	New Jersey
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Montebello	California
United States	GSK Investigational Site	Munster	Indiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Albany	Indiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Palm Springs	California
United States	GSK Investigational Site	Palo Alto	California
United States	GSK Investigational Site	Paramus	New Jersey
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pleasant Hill	California
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Roanoke	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Round Rock	Texas
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis Park	Minnesota
United States	GSK Investigational Site	Saint Louis Park	Minnesota
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Sayre	Pennsylvania
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Southfield	Michigan
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Sumter	South Carolina
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Torrington	Connecticut
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Vallejo	California
United States	GSK Investigational Site	Vancouver	Washington
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	Waterloo	Iowa
United States	GSK Investigational Site	West Hollywood	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wilkes-Barre	Pennsylvania
United States	GSK Investigational Site	Willow Grove	Pennsylvania
United States	GSK Investigational Site	Worcester	Massachusetts
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Russian Federation,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

References & Publications (2)

Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFN? Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15. — View Citation

Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population	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)
Primary	Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population	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	Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population	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	Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population	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)
Secondary	Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population	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)
Secondary	Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population	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)
Secondary	Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population	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)
Secondary	Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population	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)
Secondary	Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population	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)
Secondary	Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population	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)
Secondary	Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population	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)
Secondary	Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population	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)
Secondary	Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population	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)
Secondary	Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population	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)
Secondary	Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population	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)
Secondary	Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)	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)
Secondary	Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)	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)
Secondary	Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)	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)
Secondary	Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)	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)
Secondary	Health-related Quality of Life (HQL) Scores	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
Secondary	Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade	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)
Secondary	Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade	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)
Secondary	Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)	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)
Secondary	Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)	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)

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