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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK 249553 Group | Experimental | 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. |
|
| Placebo Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK 249553 vaccine | Biological | Intramuscular injection, 13 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence | 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. | Over a median follow-up time of 28 months post-Dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Disease Recurrence | 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. |
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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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Passlick B et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the European Multidisciplinary Conference in Thoracic Oncology (EMCTO), Lugano, Switzerland. 1-3 May 2009; 64 (suppl. 1):S45 (102PD). | ||
| Background | Vansteenkiste J et al. Activity of MAGE-A3 cancer immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study. Abstract presented at the 12th Conference on Lung Cancer (WCLC), Seoul, Korea. 2-6 September 2007. | ||
| Background | Vansteenkiste J et al. Adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study evaluating the MAGE-A3 cancer immunotherapeutic. Abstract presented at The 14th European Cancer Conference (ECCO) (formerly ECCO14/ESTRO 26), Barcelona, Spain. 23-27 September 2007. | ||
| Background | Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled Phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, Non-Small Cell Lung Cancer (NSCLC). Abstract presented at the 43rd Annual Meeting American Society of Clinical Oncology (ASCO), Chicago, IL. 1-5 June 2007. | ||
| Background | Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, non-small-cell lung cancer (NSCLC). Abstract presented at the 42nd Annual Meeting American Society of Clinical Oncology (ASCO), Atlanta, GA. 2-6 June 2006. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 249553/004 | Dataset Specification | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Biological |
Intramuscular administration, 13 doses |
|
| At 6, 12, 18, 24 and 30 months after enrolment |
| Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS) | 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. | Over a median follow-up time of 44 months post-Dose 1 |
| Number of Participants Who Died - Overall Survival (OS) | 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. | Over a median follow-up time of 44 months post-Dose 1 |
| Number of Subjects Seropositive Against MAGE-A3 | 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). | 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) |
| Anti- MAGE-A3 Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | 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) |
| Number of Subjects Seropositive Against Protein D (PD) Antigens | 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). | 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) |
| Anti-protein D (Anti-PD) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | 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) |
| Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response | Responders were patients with at least 5x10-⁶ increase in minimal CD4 precursor frequency versus baseline. Any = at least one post treatment time point. | 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) |
| Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response | Responders were patients with at least 5x10-⁶ increase in minimal CD8 precursor frequency versus baseline. Any = at least one post treatment time point. | 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) |
| Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response | 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. | At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60 |
| Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature | 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. | Over a median follow up time of 86 months |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | 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. | During the 8-day (Days 0-7) post-vaccination period, across doses |
| Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms | 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. | During the 8-day (Days 0-7) post-vaccination period, across doses |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | Within the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | 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. | Throughout the study (Day 0 - Month 86) |
| Number of Subjects With Normal and Abnormal Urinalysis Parameters | 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. | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
| Number of Subjects With Normal and Abnormal Hematological Parameters | 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. | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
| Number of Subjects With Normal and Abnormal Biochemical Parameters | 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. | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
| Edegem |
| 2650 |
| Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Tampere | 33520 | Finland |
| GSK Investigational Site | Pessac | 33600 | France |
| GSK Investigational Site | Rennes | 35033 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| GSK Investigational Site | Villingen-Schwenningen | Baden-Wurttemberg | 78050 | Germany |
| GSK Investigational Site | Ebensfeld | Bavaria | 96250 | Germany |
| GSK Investigational Site | Gauting | Bavaria | 82131 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60488 | Germany |
| GSK Investigational Site | Offenbach | Hesse | 63069 | Germany |
| GSK Investigational Site | Delmenhorst | Lower Saxony | 27753 | Germany |
| GSK Investigational Site | Hemer | North Rhine-Westphalia | 58675 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
| GSK Investigational Site | Kaiserslautern | Rhineland-Palatinate | 67655 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04129 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06114 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Bad Berka | Thuringia | 99437 | Germany |
| GSK Investigational Site | Berlin | 14109 | Germany |
| GSK Investigational Site | Marousi | 15125 | Greece |
| GSK Investigational Site | Rio-Patras | 26504 | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| GSK Investigational Site | Udine | Friuli Venezia Giulia | 33100 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Perugia | Umbria | 06156 | Italy |
| GSK Investigational Site | Venezia | Veneto | 30122 | Italy |
| GSK Investigational Site | Riga | LV 1002 | Latvia |
| GSK Investigational Site | Rigas Rajons | LV 2118 | Latvia |
| GSK Investigational Site | Vilnius | LT-01102 | Lithuania |
| GSK Investigational Site | Amsterdam | Netherlands |
| GSK Investigational Site | Nijmegen | 6525 GA | Netherlands |
| GSK Investigational Site | Oslo | Norway |
| GSK Investigational Site | Trondheim | 7006 | Norway |
| GSK Investigational Site | Chęciny | 26-060 | Poland |
| GSK Investigational Site | Gdansk | 80-211 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Tuszyn | Poland |
| GSK Investigational Site | Warsaw | Poland |
| GSK Investigational Site | Zakopane | 34-500 | Poland |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28035 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Oviedo | 33006 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07014 | Spain |
| GSK Investigational Site | Santander | 38008 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Hull | HU8 9HE | United Kingdom |
| GSK Investigational Site | London | SE1 9RS | United Kingdom |
| GSK Investigational Site |
| Background | Vansteenkiste J et al. Phase II randomized study of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): 44 month follow-up, humoral and cellular immune response data. European Society for Medical Oncology (IASLC-ESMO) Abstract presented at the 1st European Lung Cancer Conference (ELCC), Geneva, Switzerland. 23-26 April 2008; 3 (4 suppl.1):S55-56. |
| Background | Zielinski M et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the 17th European Conference on General Thoracic Surgery (ECGTS), Krakow, Poland. 31 May-3 June 2009. |
| 34870327 | Derived | Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3. |
| 23715567 | Derived | Vansteenkiste J, Zielinski M, Linder A, Dahabreh J, Gonzalez EE, Malinowski W, Lopez-Brea M, Vanakesa T, Jassem J, Kalofonos H, Perdeus J, Bonnet R, Basko J, Janilionis R, Passlick B, Treasure T, Gillet M, Lehmann FF, Brichard VG. Adjuvant MAGE-A3 immunotherapy in resected non-small-cell lung cancer: phase II randomized study results. J Clin Oncol. 2013 Jul 1;31(19):2396-403. doi: 10.1200/JCO.2012.43.7103. Epub 2013 May 28. |
| 23715562 | Derived | Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 249553/004 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence | 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. | 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. | Posted | Count of Participants | Participants | Over a median follow-up time of 28 months post-Dose 1 |
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| Secondary | Percentage of Patients With Disease Recurrence | 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. | 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. | Posted | Number | Percentage of Patients | At 6, 12, 18, 24 and 30 months after enrolment |
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| Secondary | Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS) | 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. | 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. | Posted | Count of Participants | Participants | Over a median follow-up time of 44 months post-Dose 1 |
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| Secondary | Number of Participants Who Died - Overall Survival (OS) | 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. | 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. | Posted | Count of Participants | Participants | Over a median follow-up time of 44 months post-Dose 1 |
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| Secondary | Number of Subjects Seropositive Against MAGE-A3 | 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). | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | Anti- MAGE-A3 Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | 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 | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seropositive Against Protein D (PD) Antigens | 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). | 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. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-protein D (Anti-PD) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | 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 | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response | Responders were patients with at least 5x10-⁶ increase in minimal CD4 precursor frequency versus baseline. Any = at least one post treatment time point. | 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. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response | Responders were patients with at least 5x10-⁶ increase in minimal CD8 precursor frequency versus baseline. Any = at least one post treatment time point. | 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. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response | 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. | 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. | Posted | Count of Participants | Participants | At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature | 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. | 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. | Posted | Count of Participants | Participants | Over a median follow up time of 86 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | 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. | 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. | Posted | Count of Participants | Participants | During the 8-day (Days 0-7) post-vaccination period, across doses |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms | 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. | 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. | Posted | Count of Participants | Participants | During the 8-day (Days 0-7) post-vaccination period, across doses |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | 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. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) post-vaccination period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | 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. | 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. | Posted | Count of Participants | Participants | Throughout the study (Day 0 - Month 86) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Normal and Abnormal Urinalysis Parameters | 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. | 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. | Posted | Count of Participants | Participants | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Normal and Abnormal Hematological Parameters | 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. | 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. | Posted | Count of Participants | Participants | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Normal and Abnormal Biochemical Parameters | 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. | 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. | Posted | Count of Participants | Participants | At Month 6, Month 12, Month 18, Month 24 and Month 30 |
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 54 | 122 | 41 | 122 | 120 | 122 |
| EG001 | 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. | 26 | 60 | 21 | 60 | 53 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Inguinal hernia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Adrenal gland cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchial fistula | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebral ischemia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Colonic polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic foot | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Gastritis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Malaise | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mechanical ileus | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-small cell lung cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral ischemia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleurisy | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thoracic outlet syndrome | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urethral cancer | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to kidney | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Medical observation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
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. |
|
|
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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| 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. |
|
|
|
|
| OG001 | 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. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|
| Abnormal |
|