Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.

Time frame: Over a median follow-up time of 28 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration. This analysis was based on the confirmed NSCLC recurrence so that patients withdrawn before imaging were removed.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses

Overall Survival (OS) was based on total number of deaths, irrespective of cause of death. Non-small-cell Lung Cancer Overall Survival (NSCLC-OS) was based on total number of deaths due to lung cancer; deaths due to other or to unknown causes were censored appropriately.

Time frame: Over a median follow-up time of 44 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.

Time frame: Over a median follow-up time of 44 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. Gene expression profiling was performed by qRT-PCR in primary tumor samples taken at the time of resection of the tumor, and thus before any study treatment. Gene signature positive (GS+) and negative (GS-) profiles were assessed with a 61-set gene signature (GS) and a classifier which were defined in the Phase II melanoma EORTC 16032-18031 study.

Time frame: Over a median follow up time of 86 months

Population: Analysis was performed on the Total Treated cohort Gene Signature set which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test.

A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 27.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 100.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-vaccination period, across doses

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with a documented symptom sheet.

Assessed solicited general symptoms were fatigue, headache, myalgia, nasea, rigors/chills, sweating/diaphoresis, temperature \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 4 Fatigue = Bedridden or disabling. Grade 4 Headache, Myalgia = Disabling. Grade 3 Nausea = No significant intake, requiring i.v. fluids. Grade 3 Rigors/Chills = Not responsive to narcotic medication. Grade 2 Sweating/Diaphoresis = Frequent or drenching. Grade 4 Vomiting = Requiring parenteral nutrition; or physiologic consequences requiring intensive care; haemodynamic collapse. Grade 3 fever = fever higher than (\>) 40.0 °C for more than 24 hours. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 8-day (Days 0-7) post-vaccination period, across doses

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with a documented symptom sheet.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within the 31-day (Days 0-30) post-vaccination period

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Responders are patients with at least 5x10-⁶ increase in minimal CD4 or CD8 precursor frequency versus baseline. Any = at least one post treatment time point.

Time frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

Responders were patients with at least 5x10-⁶ increase in minimal CD4 precursor frequency versus baseline. Any = at least one post treatment time point.

Time frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

Responders were patients with at least 5x10-⁶ increase in minimal CD8 precursor frequency versus baseline. Any = at least one post treatment time point.

Time frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

The parameters analysed were Albumin (ALB), Bicarbonate (BIC), Blood urea nitrogen (BUN), Calcium (CAL), Chloride (CHL), Cholesterol (CHO), Creatinine (CREA), Glucose (GLU), Magnesium (MAG), Phosphate (PHO), Potassium (POT), Sodium (SOD), Total protein (TPROT), Total bilirubin (TBIL), Triglycerides (TRIG) and Uric acid (UAC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Time frame: At Month 6, Month 12, Month 18, Month 24 and Month 30

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with data available for the respective assay.

The parameters analysed were Basophils (BAS), Eosinophils (EOS), Haemoglobin (HGB), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC), Sedimentations rate (SED) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Time frame: At Month 6, Month 12, Month 18, Month 24 and Month 30

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with data available for the respective assay.

The parameters analysed were Protein, Red Blood Cells (RBC) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Time frame: At Month 6, Month 12, Month 18, Month 24 and Month 30

Population: The analyses were performed on the Total Treated cohort gene signature (GS) set, which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test and with data available for the considered assay.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: Throughout the study (Day 0 - Month 86)

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.

Time frame: At 6, 12, 18, 24 and 30 months after enrolment

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration. This analysis was based on the confirmed NSCLC recurrence so that patients withdrawn before imaging were removed.