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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00290355
Collaborator
(none)
182
Enrollment
62
Locations
2
Arms
109.7
Actual Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

Condition or Disease Intervention/Treatment Phase
  • Biological: GSK 249553 vaccine
  • Biological: Placebo
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection
Actual Study Start Date :
May 28, 2002
Actual Primary Completion Date :
Jul 19, 2011
Actual Study Completion Date :
Jul 19, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: GSK 249553 Group

Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.

Biological: GSK 249553 vaccine
Intramuscular injection, 13 doses
Placebo Comparator: Placebo Group

Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.

Biological: Placebo
Intramuscular administration, 13 doses

Outcome Measures

Primary Outcome Measures

  1. Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence [Over a median follow-up time of 28 months post-Dose 1]

    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.

Secondary Outcome Measures

  1. Percentage of Patients With Disease Recurrence [At 6, 12, 18, 24 and 30 months after enrolment]

    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.

  2. Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS) [Over a median follow-up time of 44 months post-Dose 1]

    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.

  3. Number of Participants Who Died - Overall Survival (OS) [Over a median follow-up time of 44 months post-Dose 1]

    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.

  4. Number of Subjects Seropositive Against MAGE-A3 [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)]

    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).

  5. Anti- MAGE-A3 Antibody Concentrations [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)]

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

  6. Number of Subjects Seropositive Against Protein D (PD) Antigens [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)]

    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).

  7. Anti-protein D (Anti-PD) Antibody Concentrations [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)]

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

  8. Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response [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)]

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

  9. Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response [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)]

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

  10. Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response [At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60]

    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.

  11. Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature [Over a median follow up time of 86 months]

    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.

  12. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 8-day (Days 0-7) post-vaccination period, across doses]

    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.

  13. Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms [During the 8-day (Days 0-7) post-vaccination period, across doses]

    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.

  14. Number of Subjects With Any Unsolicited Adverse Events (AEs) [Within the 31-day (Days 0-30) post-vaccination period]

    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.

  15. Number of Subjects With Serious Adverse Events (SAEs) [Throughout the study (Day 0 - Month 86)]

    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.

  16. Number of Subjects With Normal and Abnormal Urinalysis Parameters [At Month 6, Month 12, Month 18, Month 24 and Month 30]

    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.

  17. Number of Subjects With Normal and Abnormal Hematological Parameters [At Month 6, Month 12, Month 18, Month 24 and Month 30]

    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.

  18. Number of Subjects With Normal and Abnormal Biochemical Parameters [At Month 6, Month 12, Month 18, Month 24 and Month 30]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Written informed consent has been obtained prior to surgical tumour resection and prior to the performance of any other protocol-specific procedures.

  • At least 18 years of age at the time of resection.

  • Pathologically proven, surgically staged squamous or non-squamous IB, IIA or IIB NSCLC, and complete surgical resection.

  • The operative technique for resection of the patient's tumour involves at least a lobectomy or a sleeve lobectomy, conforming to all of the following criteria:

  1. Removal of all gross disease with negative resection margins, by lobectomy, sleeve resection, bilobectomy or pneumonectomy, based on intra-operative findings.

  2. The level of nodal sampling is at least as follows:

Levels 4, 7, 10 in both right upper and right middle lobes Levels 4, 7, 9, 10 in right lower lobe Levels 5, 6, 7 in left upper lobe Levels 7, 9, 10 in left lower lobe. or at the maximum defined as systematic radical mediastinal lymphadenectomy: all ipsilateral and easily accessible lymph-node levels must be removed, independently of the location of the primary tumour. The level of nodal sampling is as follows: Levels 2, 4, 7, 8, 9, 10 in right-sided tumours, Levels 5, 6, 7, 8, 9, 10 in left-sided tumours

  • Tumour shows expression of MAGE-3 antigen.

  • Recovered from surgery for at least 4 weeks and not more than 6 weeks.

  • ECOG performance status of ≤ 1 at the time of randomisation.

  • Laboratory criteria (all of the following must be fulfilled): adequate bone marrow reserve, adequate renal function, adequate hepatic function, serum bilirubin within normal range, negative HIV antibody test, negative HBV antigen test, negative HCV antibody test.

  • (For females): EITHER not of child-bearing potential OR sexually abstinent OR all of the following: negative urine/serum β-HCG pregnancy test, use of adequate contraceptive precautions for 30 days before first vaccination. Agree to continue such precautions for 2 months after completion of the course of vaccination.

Exclusion Criteria:

  • Received any anti-cancer specific treatment including radiotherapy, prior to surgery, unless the treatment was for previous malignancies allowed by the protocol, i.e., basal and localised squamous-cell skin carcinoma that has been successfully treated, or carcinoma in situ of the cervix (see exclusion criterion no. 10).

  • Candidate for post-surgery radiation therapy or any kind of anti-cancer-specific treatment.

  • Pregnant/lactating.

  • (For female patients of child-bearing potential): not agree to practice an effective method of contraception.

  • Uncontrolled bleeding disorder.

  • Autoimmune disease.

  • History of anaphylaxis or severe allergic reaction.

  • Undergone splenectomy or radiation to the spleen.

  • Received a major organ allograft.

  • Malignancies at other sites (except (i) basal and localised squamous-cell skin carcinoma that has been successfully treated, and (ii) carcinoma in situ of the cervix).

  • Concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.

  • Uncontrolled congestive heart failure or hypertension.

  • Unstable heart disease or uncontrolled arrhythmia at the time of enrolment.

  • Psychiatric or addictive disorders that may compromise ability to give informed consent, or to comply with the trial procedures.

  • Any evidence of residual tumour after surgery.

  • Require concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.

  • Received chemotherapy, immunotherapy related to NSCLC.

  • Need home oxygenation.

  • Received any investigational or non-registered drug or vaccine other than the study vaccine within the 30 days preceding the first dose of study vaccine, or plans to receive such a drug during the study period.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Bruxelles Belgium 1200
2 GSK Investigational Site Edegem Belgium 2650
3 GSK Investigational Site Gent Belgium 9000
4 GSK Investigational Site Leuven Belgium 3000
5 GSK Investigational Site Tallinn Estonia 13419
6 GSK Investigational Site Tartu Estonia 51014
7 GSK Investigational Site Helsinki Finland 00029
8 GSK Investigational Site Tampere Finland 33520
9 GSK Investigational Site Pessac France 33600
10 GSK Investigational Site Rennes Cedex 09 France 35033
11 GSK Investigational Site Freiburg Baden-Wuerttemberg Germany 79106
12 GSK Investigational Site Heidelberg Baden-Wuerttemberg Germany 69126
13 GSK Investigational Site Villingen-Schwenningen Baden-Wuerttemberg Germany 78050
14 GSK Investigational Site Ebensfeld Bayern Germany 96250
15 GSK Investigational Site Gauting Bayern Germany 82131
16 GSK Investigational Site Muenchen Bayern Germany 81675
17 GSK Investigational Site Frankfurt Hessen Germany 60488
18 GSK Investigational Site Offenbach Hessen Germany 63069
19 GSK Investigational Site Delmenhorst Niedersachsen Germany 27753
20 GSK Investigational Site Hemer Nordrhein-Westfalen Germany 58675
21 GSK Investigational Site Witten Nordrhein-Westfalen Germany 58455
22 GSK Investigational Site Kaiserslautern Rheinland-Pfalz Germany 67655
23 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55131
24 GSK Investigational Site Halle (Saale) Sachsen-Anhalt Germany 06114
25 GSK Investigational Site Halle Sachsen-Anhalt Germany 06120
26 GSK Investigational Site Leipzig Sachsen Germany 04129
27 GSK Investigational Site Grosshansdorf Schleswig-Holstein Germany 22927
28 GSK Investigational Site Bad Berka Thueringen Germany 99437
29 GSK Investigational Site Berlin Germany 14109
30 GSK Investigational Site Marousi Greece 15125
31 GSK Investigational Site Rio-Patras Greece 26504
32 GSK Investigational Site Thessaloniki Greece 57010
33 GSK Investigational Site Pordenone Friuli-Venezia-Giulia Italy 33170
34 GSK Investigational Site Udine Friuli-Venezia-Giulia Italy 33100
35 GSK Investigational Site Genova Liguria Italy 16132
36 GSK Investigational Site Perugia Umbria Italy 06156
37 GSK Investigational Site Venezia Veneto Italy 30122
38 GSK Investigational Site Rigas Rajons Latvia LV 2118
39 GSK Investigational Site Riga Latvia LV 1002
40 GSK Investigational Site Vilnius Lithuania LT-01102
41 GSK Investigational Site Amsterdam Netherlands
42 GSK Investigational Site Nijmegen Netherlands 6525 GA
43 GSK Investigational Site Oslo Norway
44 GSK Investigational Site Trondheim Norway 7006
45 GSK Investigational Site Checiny Poland 26-060
46 GSK Investigational Site Gdansk Poland 80-211
47 GSK Investigational Site Poznan Poland 60-569
48 GSK Investigational Site Tuszyn Poland
49 GSK Investigational Site Warszawa Poland
50 GSK Investigational Site Zakopane Poland 34-500
51 GSK Investigational Site Barcelona Spain 08036
52 GSK Investigational Site La Coruña Spain 15006
53 GSK Investigational Site Madrid Spain 28035
54 GSK Investigational Site Madrid Spain 28040
55 GSK Investigational Site Madrid Spain 28047
56 GSK Investigational Site Oviedo Spain 33006
57 GSK Investigational Site Palma de Mallorca Spain 07014
58 GSK Investigational Site Santander Spain 38008
59 GSK Investigational Site Valencia Spain 46010
60 GSK Investigational Site Hull United Kingdom HU8 9HE
61 GSK Investigational Site London United Kingdom SE1 9RS
62 GSK Investigational Site

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00290355
Other Study ID Numbers:
  • 249553/004
First Posted:
Feb 13, 2006
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Period Title: Overall Study
STARTED 122 60
COMPLETED 105 55
NOT COMPLETED 17 5

Baseline Characteristics

Arm/Group Title GSK 249553 Group Placebo Group Total
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Total of all reporting groups
Overall Participants 122 60 182
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
62.5
(7.85)
62.6
(8.88)
62.53
(8.18)
Sex: Female, Male (Count of Participants)
Female
16
13.1%
7
11.7%
23
12.6%
Male
106
86.9%
53
88.3%
159
87.4%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian
122
100%
60
100%
182
100%

Outcome Measures

1. Primary Outcome
Title Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 114 57
Count of Participants [Participants]
37
30.3%
24
40%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK 249553 Group, Placebo Group
Comments Hazard ratio of GSK 249553 study product.
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value 0.256
Comments Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = [HR=1]).
Method Regression, Cox
Comments The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value < 10%
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.44 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Percentage of Patients With Disease Recurrence
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 114 57
Recurrence at Month 6
89.1
91.5
Recurrence at Month 12
78.6
70.8
Recurrence at Month 18
72.4
62.0
Recurrence at Month 24
68.8
58.3
Recurrence at Month 30
63.8
58.3
3. Secondary Outcome
Title Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS)
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 122 60
Count of Participants [Participants]
49
40.2%
29
48.3%
4. Secondary Outcome
Title Number of Participants Who Died - Overall Survival (OS)
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 122 60
Deaths, any cause
36
29.5%
21
35%
Deaths, NSCLC-related
27
22.1%
13
21.7%
5. Secondary Outcome
Title Number of Subjects Seropositive Against MAGE-A3
Description 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 119 57
Day 0
9
7.4%
6
10%
Week 6
88
72.1%
4
6.7%
Week 12
98
80.3%
5
8.3%
Month 9
75
61.5%
2
3.3%
Month 18
56
45.9%
2
3.3%
Month 24
52
42.6%
1
1.7%
Month 30
44
36.1%
2
3.3%
FU visit
25
20.5%
1
1.7%
6. Secondary Outcome
Title Anti- MAGE-A3 Antibody Concentrations
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 119 57
Day 0
16.9
17.8
Week 6
120.1
17.0
Week 12
1017.4
18.7
Month 9
505.9
14.7
Month 18
673.7
14.7
Month 24
627.5
14.0
Month 30
783.0
14.8
FU visit
187.8
16.1
7. Secondary Outcome
Title Number of Subjects Seropositive Against Protein D (PD) Antigens
Description 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 115 55
Day 0
45
36.9%
16
26.7%
Week 6
100
82%
19
31.7%
Week 12
99
81.1%
20
33.3%
Month 9
75
61.5%
12
20%
Month 18
56
45.9%
11
18.3%
Month 24
52
42.6%
7
11.7%
Month 30
43
35.2%
8
13.3%
FU visit
26
21.3%
0
0%
8. Secondary Outcome
Title Anti-protein D (Anti-PD) Antibody Concentrations
Description 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)

Outcome Measure Data

Analysis Population Description
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
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 115 55
Day 0
92.2
71.6
Week 6
711.7
78.9
Week 12
2694.0
87.7
Month 9
1455.8
88.3
Month 18
2029.0
85.9
Month 24
1587.7
78.9
Month 30
2018.4
78.8
FU visit
812.6
50.0
9. Secondary Outcome
Title Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response
Description 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 37 14
Week 6
8
6.6%
2
3.3%
Week 12
7
5.7%
1
1.7%
Month 9
0
0%
1
1.7%
Month 18
2
1.6%
0
0%
Month 24
1
0.8%
1
1.7%
Month 30
2
1.6%
1
1.7%
FU visit
2
1.6%
0
0%
Any
15
12.3%
1
1.7%
10. Secondary Outcome
Title Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response
Description 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 34 16
Week 6
2
1.6%
3
5%
Week 12
1
0.8%
0
0%
Month 9
3
2.5%
1
1.7%
Month 18
3
2.5%
1
1.7%
Month 24
0
0%
1
1.7%
Month 30
1
0.8%
0
0%
FU visit
1
0.8%
1
1.7%
Any
9
7.4%
6
10%
11. Secondary Outcome
Title Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 40 18
Week 6
10
8.2%
5
8.3%
Week 12
8
6.6%
1
1.7%
Month 9
3
2.5%
2
3.3%
Month 18
3
2.5%
1
1.7%
Month 24
1
0.8%
1
1.7%
Month 30
2
1.6%
1
1.7%
Month 60
2
1.6%
1
1.7%
Any
21
17.2%
7
11.7%
12. Secondary Outcome
Title Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 106 51
GS+
13
10.7%
9
15%
GS-
31
25.4%
12
20%
13. Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 121 58
Any Pain
116
95.1%
36
60%
Grade 3 Pain
59
48.4%
2
3.3%
Any Redness
96
78.7%
24
40%
Grade 3 Redness
66
54.1%
2
3.3%
Any Swelling
91
74.6%
19
31.7%
Grade 3 Swelling
52
42.6%
4
6.7%
14. Secondary Outcome
Title Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 121 58
Any Fatigue
87
71.3%
32
53.3%
Grade 4 Fatigue
2
1.6%
1
1.7%
Related Fatigue
78
63.9%
23
38.3%
Any Headache
81
66.4%
24
40%
Grade 4 Headache
1
0.8%
0
0%
Related Headache
69
56.6%
16
26.7%
Any Myalgia
90
73.8%
29
48.3%
Grade 4 Myalgia
5
4.1%
1
1.7%
Related Myalgia
77
63.1%
24
40%
Any Nausea
46
37.7%
18
30%
Grade 3 Nausea
1
0.8%
0
0%
Related Nausea
42
34.4%
15
25%
Any Rigors/Chills
62
50.8%
13
21.7%
Grade 3 Rigors/Chills
8
6.6%
0
0%
Any Sweating/Diaphoresis
62
50.8%
19
31.7%
Grade 2 Sweating/Diaphoresis
25
20.5%
9
15%
Related Sweating/Diaphoresis
53
43.4%
16
26.7%
Any Temperature
45
36.9%
8
13.3%
Grade 3 Temperature
0
0%
0
0%
Related Temperature
40
32.8%
3
5%
Any Vomiting
16
13.1%
9
15%
Grade 4 Vomiting
0
0%
0
0%
Related Vomiting
13
10.7%
7
11.7%
15. Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 122 60
Count of Participants [Participants]
95
77.9%
50
83.3%
16. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Description 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)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 122 60
Count of Participants [Participants]
41
33.6%
21
35%
17. Secondary Outcome
Title Number of Subjects With Normal and Abnormal Urinalysis Parameters
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 100 50
Normal
100
82%
50
83.3%
Abnormal
0
0%
0
0%
Normal
86
70.5%
38
63.3%
Abnormal
0
0%
0
0%
Normal
72
59%
33
55%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
23
38.3%
Abnormal
0
0%
0
0%
Normal
100
82%
50
83.3%
Abnormal
0
0%
0
0%
Normal
86
70.5%
38
63.3%
Abnormal
0
0%
0
0%
Normal
72
59%
33
55%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
23
38.3%
Abnormal
0
0%
0
0%
Normal
100
82%
50
83.3%
Abnormal
0
0%
0
0%
Normal
86
70.5%
38
63.3%
Abnormal
0
0%
0
0%
Normal
72
59%
33
55%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
23
38.3%
Abnormal
0
0%
0
0%
18. Secondary Outcome
Title Number of Subjects With Normal and Abnormal Hematological Parameters
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 122 59
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
119
97.5%
59
98.3%
Abnormal
0
0%
0
0%
Normal
109
89.3%
51
85%
Abnormal
1
0.8%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
110
90.2%
51
85%
Abnormal
1
0.8%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
111
91%
51
85%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
121
99.2%
59
98.3%
Abnormal
0
0%
0
0%
Normal
122
100%
59
98.3%
Abnormal
0
0%
0
0%
Normal
120
98.4%
59
98.3%
Abnormal
0
0%
0
0%
Normal
110
90.2%
51
85%
Abnormal
1
0.8%
0
0%
19. Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical Parameters
Description 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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Measure Participants 97 45
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
33
55%
Abnormal
0
0%
1
1.7%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
91
74.6%
43
71.7%
Abnormal
1
0.8%
1
1.7%
Normal
80
65.6%
33
55%
Abnormal
0
0%
1
1.7%
Normal
67
54.9%
30
50%
Abnormal
0
0%
0
0%
Normal
65
53.3%
30
50%
Abnormal
0
0%
1
1.7%
Normal
53
43.4%
22
36.7%
Abnormal
0
0%
0
0%
Normal
2
1.6%
0
0%
Abnormal
3
2.5%
1
1.7%
Normal
2
1.6%
0
0%
Abnormal
3
2.5%
0
0%
Normal
1
0.8%
0
0%
Abnormal
2
1.6%
0
0%
Normal
1
0.8%
0
0%
Abnormal
2
1.6%
0
0%
Normal
2
1.6%
0
0%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
96
78.7%
44
73.3%
Abnormal
1
0.8%
0
0%
Normal
85
69.7%
33
55%
Abnormal
0
0%
0
0%
Normal
70
57.4%
29
48.3%
Abnormal
0
0%
0
0%
Normal
68
55.7%
30
50%
Abnormal
0
0%
0
0%
Normal
55
45.1%
21
35%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
84
68.9%
34
56.7%
Abnormal
1
0.8%
0
0%
Normal
69
56.6%
30
50%
Abnormal
1
0.8%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
94
77%
45
75%
Abnormal
2
1.6%
0
0%
Normal
83
68%
32
53.3%
Abnormal
1
0.8%
1
1.7%
Normal
70
57.4%
28
46.7%
Abnormal
0
0%
1
1.7%
Normal
67
54.9%
29
48.3%
Abnormal
1
0.8%
1
1.7%
Normal
54
44.3%
22
36.7%
Abnormal
1
0.8%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
96
78.7%
45
75%
Abnormal
0
0%
0
0%
Normal
83
68%
34
56.7%
Abnormal
1
0.8%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
30
50%
Abnormal
0
0%
1
1.7%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
96
78.7%
45
75%
Abnormal
1
0.8%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
67
54.9%
31
51.7%
Abnormal
1
0.8%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
45
75%
Abnormal
0
0%
0
0%
Normal
85
69.7%
34
56.7%
Abnormal
0
0%
0
0%
Normal
70
57.4%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
31
51.7%
Abnormal
0
0%
0
0%
Normal
55
45.1%
22
36.7%
Abnormal
0
0%
0
0%
Normal
97
79.5%
44
73.3%
Abnormal
0
0%
0
0%
Normal
85
69.7%
33
55%
Abnormal
0
0%
0
0%
Normal
70
57.4%
29
48.3%
Abnormal
0
0%
0
0%
Normal
68
55.7%
30
50%
Abnormal
0
0%
0
0%
Normal
55
45.1%
21
35%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
0
0%
1
1.7%
Abnormal
0
0%
0
0%
Normal
95
77.9%
44
73.3%
Abnormal
1
0.8%
1
1.7%
Normal
83
68%
34
56.7%
Abnormal
1
0.8%
0
0%
Normal
69
56.6%
30
50%
Abnormal
0
0%
0
0%
Normal
68
55.7%
29
48.3%
Abnormal
0
0%
2
3.3%
Normal
54
44.3%
22
36.7%
Abnormal
1
0.8%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%
Normal
1
0.8%
0
0%
Abnormal
0
0%
0
0%

Adverse Events

Time Frame All-Cause Mortality and SAEs: during the entire study period (Month 0 up to Month 86). Other Adverse Events - Solicited local and general symptoms: during the 8-day (Days 0-7) post-product administration period; - Unsolicited AEs: within the 31-day (Days 0-30) post-product administration period.
Adverse Event Reporting Description Deaths, as study events, were not all recorded as SAEs. Only deaths occurring in patients without recurrence during the Treatment Phase of the study (up to Month 30) and recorded as fatal SAEs are reported and not all deaths reported without recurrence were classified as fatal SAEs.
Arm/Group Title GSK 249553 Group Placebo Group
Arm/Group Description Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
All Cause Mortality
GSK 249553 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 54/122 (44.3%) 26/60 (43.3%)
Serious Adverse Events
GSK 249553 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 41/122 (33.6%) 21/60 (35%)
Blood and lymphatic system disorders
Hyperglycaemia 1/122 (0.8%) 0/60 (0%)
Lymphadenopathy 0/122 (0%) 1/60 (1.7%)
Lymphocele 1/122 (0.8%) 0/60 (0%)
Cardiac disorders
Myocardial infarction 2/122 (1.6%) 1/60 (1.7%)
Acute myocardial infarction 0/122 (0%) 2/60 (3.3%)
Cardiac failure 1/122 (0.8%) 1/60 (1.7%)
Atrial fibrillation 1/122 (0.8%) 0/60 (0%)
Myocardial ischemia 0/122 (0%) 1/60 (1.7%)
Pericarditis 0/122 (0%) 1/60 (1.7%)
Supraventricular tachycardia 0/122 (0%) 1/60 (1.7%)
Coronary artery disease 1/122 (0.8%) 0/60 (0%)
Gastrointestinal disorders
Malaise 1/122 (0.8%) 0/60 (0%)
General disorders
Injection site reaction 1/122 (0.8%) 0/60 (0%)
Medical observation 1/122 (0.8%) 0/60 (0%)
Immune system disorders
Sarcoidosis 1/122 (0.8%) 0/60 (0%)
Infections and infestations
Bronchial fistula 0/122 (0%) 1/60 (1.7%)
Bronchitis 1/122 (0.8%) 0/60 (0%)
Cholecystitis infective 0/122 (0%) 1/60 (1.7%)
Diabetic foot 1/122 (0.8%) 0/60 (0%)
Empyema 0/122 (0%) 1/60 (1.7%)
Localised infection 0/122 (0%) 1/60 (1.7%)
Pancreatitis acute 0/122 (0%) 1/60 (1.7%)
Pleurisy 1/122 (0.8%) 0/60 (0%)
Wound infection 0/122 (0%) 1/60 (1.7%)
Injury, poisoning and procedural complications
Head injury 1/122 (0.8%) 0/60 (0%)
Procedural pain 1/122 (0.8%) 0/60 (0%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control 1/122 (0.8%) 0/60 (0%)
Electrolyte imbalance 1/122 (0.8%) 0/60 (0%)
Gastritis 1/122 (0.8%) 0/60 (0%)
Musculoskeletal and connective tissue disorders
Inguinal hernia 1/122 (0.8%) 1/60 (1.7%)
Mechanical ileus 1/122 (0.8%) 0/60 (0%)
Sciatica 1/122 (0.8%) 0/60 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system 2/122 (1.6%) 1/60 (1.7%)
Bladder cancer 1/122 (0.8%) 0/60 (0%)
Adrenal gland cancer metastatic 0/122 (0%) 1/60 (1.7%)
Benign breast neoplasm 1/122 (0.8%) 0/60 (0%)
Breast cancer 0/122 (0%) 1/60 (1.7%)
Colon cancer 1/122 (0.8%) 0/60 (0%)
Colon cancer metastatic 1/122 (0.8%) 0/60 (0%)
Colonic polyp 1/122 (0.8%) 0/60 (0%)
Gastric cancer 1/122 (0.8%) 0/60 (0%)
Lung carcinoma cell type unspecified recurrent 0/122 (0%) 1/60 (1.7%)
Metastases to bone 1/122 (0.8%) 0/60 (0%)
Metastases to lung 1/122 (0.8%) 0/60 (0%)
Non-small cell lung cancer 1/122 (0.8%) 0/60 (0%)
Non-small cell lung cancer recurrent 0/122 (0%) 1/60 (1.7%)
Nervous system disorders
Cerebral ischemia 1/122 (0.8%) 0/60 (0%)
Cerebrovascular accident 1/122 (0.8%) 0/60 (0%)
Diabetic neuropathy 1/122 (0.8%) 0/60 (0%)
Hemiparesis 1/122 (0.8%) 0/60 (0%)
Hypotonia 1/122 (0.8%) 0/60 (0%)
Peripheral ischemia 1/122 (0.8%) 0/60 (0%)
Psychiatric disorders
Anxiety 1/122 (0.8%) 0/60 (0%)
Renal and urinary disorders
Renal failure 1/122 (0.8%) 0/60 (0%)
Urethral cancer 1/122 (0.8%) 0/60 (0%)
Urinary tract infection 0/122 (0%) 1/60 (1.7%)
Bladder transitional cell carcinoma 1/122 (0.8%) 0/60 (0%)
Metastases to kidney 1/122 (0.8%) 0/60 (0%)
Reproductive system and breast disorders
Gynaecomastia 0/122 (0%) 1/60 (1.7%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease 4/122 (3.3%) 2/60 (3.3%)
Pneumonia 4/122 (3.3%) 1/60 (1.7%)
Dyspnoea 2/122 (1.6%) 0/60 (0%)
Haemoptysis 1/122 (0.8%) 0/60 (0%)
Hyperventilation 1/122 (0.8%) 0/60 (0%)
Non-cardiac chest pain 1/122 (0.8%) 0/60 (0%)
Pleural effusion 1/122 (0.8%) 0/60 (0%)
Pneumothorax 0/122 (0%) 1/60 (1.7%)
Pulmonary embolism 0/122 (0%) 1/60 (1.7%)
Pulmonary oedema 1/122 (0.8%) 0/60 (0%)
Skin and subcutaneous tissue disorders
Rash 0/122 (0%) 1/60 (1.7%)
Small cell lung cancer stage unspecified 1/122 (0.8%) 0/60 (0%)
Vascular disorders
Peripheral artery aneurysm 1/122 (0.8%) 0/60 (0%)
Syncope 1/122 (0.8%) 0/60 (0%)
Thoracic outlet syndrome 1/122 (0.8%) 0/60 (0%)
Peripheral arterial occlusive disease 1/122 (0.8%) 0/60 (0%)
Other (Not Including Serious) Adverse Events
GSK 249553 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 120/122 (98.4%) 53/60 (88.3%)
Gastrointestinal disorders
Abdominal pain 0/122 (0%) 0 4/60 (6.7%) 4
Nausea 46/122 (37.7%) 174 18/60 (30%) 70
Vomiting 17/122 (13.9%) 33 10/60 (16.7%) 22
General disorders
Chest pain 19/122 (15.6%) 22 9/60 (15%) 10
Chills 62/122 (50.8%) 267 13/60 (21.7%) 43
Fatigue 87/122 (71.3%) 504 32/60 (53.3%) 164
Pain 116/122 (95.1%) 947 36/60 (60%) 208
Pyrexia 45/122 (36.9%) 120 8/60 (13.3%) 12
Swelling 91/122 (74.6%) 552 19/60 (31.7%) 69
Infections and infestations
Bronchitis 7/122 (5.7%) 10 0/60 (0%) 0
Nasopharyngitis 9/122 (7.4%) 12 4/60 (6.7%) 4
Respiratory tract infection 1/122 (0.8%) 1 3/60 (5%) 3
Musculoskeletal and connective tissue disorders
Back pain 4/122 (3.3%) 4 4/60 (6.7%) 4
Myalgia 90/122 (73.8%) 537 29/60 (48.3%) 132
Nervous system disorders
Headache 82/122 (67.2%) 369 24/60 (40%) 110
Respiratory, thoracic and mediastinal disorders
Cough 33/122 (27%) 49 15/60 (25%) 19
Dyspnoea 23/122 (18.9%) 32 10/60 (16.7%) 14
Productive cough 4/122 (3.3%) 5 7/60 (11.7%) 7
Skin and subcutaneous tissue disorders
Erythema 97/122 (79.5%) 625 24/60 (40%) 114
Hyperhidrosis 62/122 (50.8%) 271 20/60 (33.3%) 94
Surgical and medical procedures
Hospitalisation 17/122 (13.9%) 24 7/60 (11.7%) 11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00290355
Other Study ID Numbers:
  • 249553/004
First Posted:
Feb 13, 2006
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019