AzTrials
AzTrials

Lung Cancer, Non-Small CellPhase 2NCT00290355

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

A Phase 2 study testing GSK 249553 vaccine in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 62 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
GSK 249553 vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
62 sitesin 15 countries
Study dates
28 May 2002to 19 Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Removal of all gross disease with negative resection margins, by lobectomy, sleeve resection, bilobectomy or pneumonectomy, based on intra-operative findings.
  • The level of nodal sampling is at least as follows:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

62 sites in 15 countries.

62 sites in 15 countries

Germany19 sites

  • GSK Investigational Site

    Bad Berka, Thuringia, 99437

  • GSK Investigational Site

    Berlin, 14109

  • GSK Investigational Site

    Delmenhorst, Lower Saxony, 27753

  • GSK Investigational Site

    Ebensfeld, Bavaria, 96250

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60488

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Gauting, Bavaria, 82131

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06114

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Hemer, North Rhine-Westphalia, 58675

  • GSK Investigational Site

    Kaiserslautern, Rhineland-Palatinate, 67655

  • GSK Investigational Site

    Leipzig, Saxony, 04129

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Munich, Bavaria, 81675

  • GSK Investigational Site

    Offenbach, Hesse, 63069

  • GSK Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78050

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

Spain9 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Santander, 38008

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Poland6 sites

  • GSK Investigational Site

    Chęciny, 26-060

  • GSK Investigational Site

    Gdansk, 80-211

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Tuszyn

  • GSK Investigational Site

    Warsaw

  • GSK Investigational Site

    Zakopane, 34-500

Other trials in Poland

Italy5 sites

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Pordenone, Friuli Venezia Giulia, 33170

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

  • GSK Investigational Site

    Venezia, Veneto, 30122

Other trials in Italy

Belgium4 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Greece3 sites

  • GSK Investigational Site

    Marousi, 15125

  • GSK Investigational Site

    Rio-Patras, 26504

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Finland2 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Tampere, 33520

Other trials in Finland

France2 sites

  • GSK Investigational Site

    Pessac, 33600

  • GSK Investigational Site

    Rennes, 35033

Other trials in France

Latvia2 sites

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Rigas Rajons, LV 2118

Other trials in Latvia

Netherlands2 sites

  • GSK Investigational Site

    Amsterdam

  • GSK Investigational Site

    Nijmegen, 6525 GA

Other trials in Netherlands

Norway2 sites

  • GSK Investigational Site

    Oslo

  • GSK Investigational Site

    Trondheim, 7006

Other trials in Norway

United Kingdom2 sites

  • GSK Investigational Site

    Hull, HU8 9HE

  • GSK Investigational Site

    London, SE1 9RS

Other trials in United Kingdom

Lithuania1 site

  • GSK Investigational Site

    Vilnius, LT-01102

Other trials in Lithuania

Location not given1 site

  • GSK Investigational Site

About this study

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

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.

Read the 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.

Being tested
GSK 249553 vaccine, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK 249553 vaccineBiological

    Intramuscular injection, 13 doses

  • PlaceboBiological

    Intramuscular administration, 13 doses

Study groups in NCT00290355
Study groupRoleWhat they receive
GSK 249553 GroupExperimentalMale 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.
Receives: Biological: GSK 249553 vaccine
Placebo GroupPlacebo comparatorMale 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.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (18)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

    Measured: 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)

  5. 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).

    Measured: 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)

  6. 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).

    Measured: 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)

  7. 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).

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. 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.

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

  11. 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.

    Measured: Over a median follow up time of 86 months

  12. 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.

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

  13. 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.

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

  14. 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.

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

  15. 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.

    Measured: Throughout the study (Day 0 - Month 86)

  16. 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.

    Measured: At Month 6, Month 12, Month 18, Month 24 and Month 30

  17. 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.

    Measured: At Month 6, Month 12, Month 18, Month 24 and Month 30

  18. 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.

    Measured: At Month 6, Month 12, Month 18, Month 24 and Month 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study start28 May 2002
  3. Primary completion19 Jul 2011
  4. Study completion19 Jul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290355
Sponsor's protocol ID
249553/004
Status last verified
Dec 2019
First submitted
10 Feb 2006
Last updated
2 Jan 2020
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

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.

  • 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.

    PubMed 34870327

  • 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.

    PubMed 23715567

  • 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.

    PubMed 23715562

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK 249553 vaccine in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 62 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Germany, Spain, Poland, Italy, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290355, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in