Primary Outcome Measures:
- Number of days from surgical resection to the recurrence of NSCLC (all types of recurrence will be included). [ Time Frame: At the time of analysis ]
Secondary Outcome Measures:
- Recurrence [ Time Frame: 6, 12, 18, 24 and 30 months after enrolment ]
- Disease-free survival [ Time Frame: At the time of analysis ]
- Time to death [ Time Frame: At the time of analysis ]
- Time to lung cancer death [ Time Frame: At the time of analysis ]
- Lung-cancer-related death. [ Time Frame: 30 months after enrolment ]
- Antibodies to MAGE-3 and protein D [ Time Frame: At all points during treatment as specified in the study schedule ]
- In vitro cellular immune response [ Time Frame: At all points during treatment as specified in the study schedule ]
- Serum level of Cyfra21.1 and CEA [ Time Frame: At all points during treatment as specified in the study schedule ]
- Level of plasma DNA and molecular characterisation by loss of heterozygosity and microsatellite instability [ Time Frame: At all points during treatment as specified in the study schedule. ]
- Number of circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
- MAGE-3 expression in circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
- Gene expression profiles of primary and relapsed tumour samples [ Time Frame: At the time of resection ]
- Proteomes of the patients' plasma [ Time Frame: At all points during treatment as specified in the study schedule ]
- Solicited local and general signs and symptoms recorded by the patients on diary cards [ Time Frame: For a period of 7 days following each administration of vaccine/placebo ]
- Unsolicited non-serious adverse events [ Time Frame: Reported at any time until 30 days following the most recent administration of vaccine/placebo ]
- All serious adverse events [ Time Frame: At any time during the study ]
- Haematological, biochemical and urinalysis parameters [ Time Frame: At regular intervals during the study ]
This Phase IIb study will be conducted at centres in several European countries according to a multicentre, international, randomised, double-blind design. It will provide information about the clinical and immunological efficacy and the tolerability of GSK 249553 when this is administered to patients with stage IB, II NSCLC. The study treatment will be administered by intramuscular injection; first administration will take place 4-6 weeks after surgery. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.