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

• ClinicalTrials.gov Identifier: NCT00290355
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Results First Posted: February 25, 2019
• Last Update Posted: January 2, 2020
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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
Lung Cancer, Non-Small Cell	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 (Clinical Trial)
• 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: July 19, 2011
• Actual Study Completion Date: July 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ 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) ]
   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 [ 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) ]
   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 [ 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) ]
   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 [ 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) ]
   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 [ 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) ]
   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 [ 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) ]
   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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Belgium

GSK Investigational Site

Bruxelles, Belgium, 1200

GSK Investigational Site

Edegem, Belgium, 2650

GSK Investigational Site

Gent, Belgium, 9000

GSK Investigational Site

Leuven, Belgium, 3000

Estonia

GSK Investigational Site

Tallinn, Estonia, 13419

GSK Investigational Site

Tartu, Estonia, 51014

Finland

GSK Investigational Site

Helsinki, Finland, 00029

GSK Investigational Site

Tampere, Finland, 33520

France

GSK Investigational Site

Pessac, France, 33600

GSK Investigational Site

Rennes Cedex 09, France, 35033

Germany

GSK Investigational Site

Freiburg, Baden-Wuerttemberg, Germany, 79106

GSK Investigational Site

Heidelberg, Baden-Wuerttemberg, Germany, 69126

GSK Investigational Site

Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78050

GSK Investigational Site

Ebensfeld, Bayern, Germany, 96250

GSK Investigational Site

Gauting, Bayern, Germany, 82131

GSK Investigational Site

Muenchen, Bayern, Germany, 81675

GSK Investigational Site

Frankfurt, Hessen, Germany, 60488

GSK Investigational Site

Offenbach, Hessen, Germany, 63069

GSK Investigational Site

Delmenhorst, Niedersachsen, Germany, 27753

GSK Investigational Site

Hemer, Nordrhein-Westfalen, Germany, 58675

GSK Investigational Site

Witten, Nordrhein-Westfalen, Germany, 58455

GSK Investigational Site

Kaiserslautern, Rheinland-Pfalz, Germany, 67655

GSK Investigational Site

Mainz, Rheinland-Pfalz, Germany, 55131

GSK Investigational Site

Halle (Saale), Sachsen-Anhalt, Germany, 06114

GSK Investigational Site

Halle, Sachsen-Anhalt, Germany, 06120

GSK Investigational Site

Leipzig, Sachsen, Germany, 04129

GSK Investigational Site

Grosshansdorf, Schleswig-Holstein, Germany, 22927

GSK Investigational Site

Bad Berka, Thueringen, Germany, 99437

GSK Investigational Site

Berlin, Germany, 14109

Greece

GSK Investigational Site

Marousi, Greece, 15125

GSK Investigational Site

Rio-Patras, Greece, 26504

GSK Investigational Site

Thessaloniki, Greece, 57010

Italy

GSK Investigational Site

Pordenone, Friuli-Venezia-Giulia, Italy, 33170

GSK Investigational Site

Udine, Friuli-Venezia-Giulia, Italy, 33100

GSK Investigational Site

Genova, Liguria, Italy, 16132

GSK Investigational Site

Perugia, Umbria, Italy, 06156

GSK Investigational Site

Venezia, Veneto, Italy, 30122

Latvia

GSK Investigational Site

Rigas Rajons, Latvia, LV 2118

GSK Investigational Site

Riga, Latvia, LV 1002

Lithuania

GSK Investigational Site

Vilnius, Lithuania, LT-01102

Netherlands

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Nijmegen, Netherlands, 6525 GA

Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Trondheim, Norway, 7006

Poland

GSK Investigational Site

Checiny, Poland, 26-060

GSK Investigational Site

Gdansk, Poland, 80-211

GSK Investigational Site

Poznan, Poland, 60-569

GSK Investigational Site

Tuszyn, Poland

GSK Investigational Site

Warszawa, Poland

GSK Investigational Site

Zakopane, Poland, 34-500

Spain

GSK Investigational Site

Barcelona, Spain, 08036

GSK Investigational Site

La Coruña, Spain, 15006

GSK Investigational Site

Madrid, Spain, 28035

GSK Investigational Site

Madrid, Spain, 28040

GSK Investigational Site

Madrid, Spain, 28047

GSK Investigational Site

Oviedo, Spain, 33006

GSK Investigational Site

Palma de Mallorca, Spain, 07014

GSK Investigational Site

Santander, Spain, 38008

GSK Investigational Site

Valencia, Spain, 46010

United Kingdom

GSK Investigational Site

Hull, United Kingdom, HU8 9HE

GSK Investigational Site

London, United Kingdom, SE1 9RS

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 249553/004
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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).

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD011300. doi: 10.1002/14651858.CD011300.pub3. Review.

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.

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00290355
• Other Study ID Numbers: 249553/004
• First Posted: February 13, 2006
• Results First Posted: February 25, 2019
• Last Update Posted: January 2, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: 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.
• URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=4970

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms