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

NCT00290355 | Completed Phase 2 Results

• 1 other identifier: 249553/004
• Study Type: interventional
• Target: 182
• Locations: 13 countries
• Sites: 59

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.

Conditions

Lung Cancer, Non-Small Cell

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (18)

• Percentage of Patients With Disease Recurrence

  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)

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

• Number of Participants Who Died - Overall Survival (OS)

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

• Number of Subjects Seropositive Against MAGE-A3

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

• Anti- MAGE-A3 Antibody Concentrations

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

Study Arms (2)

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.

Biological: GSK 249553 vaccine

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.

Biological: Placebo

Interventions

GSK 249553 vaccine BIOLOGICAL

Intramuscular injection, 13 doses

GSK 249553 Group

Placebo BIOLOGICAL

Intramuscular administration, 13 doses

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (62)

GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Tallinn, 13419, Estonia

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GSK Investigational Site

Tartu, 51014, Estonia

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GSK Investigational Site

Helsinki, 00029, Finland

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GSK Investigational Site

Tampere, 33520, Finland

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GSK Investigational Site

Pessac, 33600, France

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GSK Investigational Site

Rennes, 35033, France

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69126, Germany

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GSK Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, 78050, Germany

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GSK Investigational Site

Ebensfeld, Bavaria, 96250, Germany

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GSK Investigational Site

Gauting, Bavaria, 82131, Germany

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GSK Investigational Site

Munich, Bavaria, 81675, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60488, Germany

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GSK Investigational Site

Offenbach, Hesse, 63069, Germany

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GSK Investigational Site

Delmenhorst, Lower Saxony, 27753, Germany

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GSK Investigational Site

Hemer, North Rhine-Westphalia, 58675, Germany

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GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

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GSK Investigational Site

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

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GSK Investigational Site

Leipzig, Saxony, 04129, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06114, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

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GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

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GSK Investigational Site

Bad Berka, Thuringia, 99437, Germany

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GSK Investigational Site

Berlin, 14109, Germany

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GSK Investigational Site

Marousi, 15125, Greece

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GSK Investigational Site

Rio-Patras, 26504, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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GSK Investigational Site

Pordenone, Friuli Venezia Giulia, 33170, Italy

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GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Perugia, Umbria, 06156, Italy

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GSK Investigational Site

Venezia, Veneto, 30122, Italy

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GSK Investigational Site

Riga, LV 1002, Latvia

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GSK Investigational Site

Rigas Rajons, LV 2118, Latvia

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GSK Investigational Site

Vilnius, LT-01102, Lithuania

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GSK Investigational Site

Amsterdam, Netherlands

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GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

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GSK Investigational Site

Oslo, Norway

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GSK Investigational Site

Trondheim, 7006, Norway

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GSK Investigational Site

Chęciny, 26-060, Poland

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GSK Investigational Site

Gdansk, 80-211, Poland

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GSK Investigational Site

Poznan, 60-569, Poland

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GSK Investigational Site

Tuszyn, Poland

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GSK Investigational Site

Warsaw, Poland

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GSK Investigational Site

Zakopane, 34-500, Poland

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GSK Investigational Site

A Coruña, 15006, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Madrid, 28035, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28047, Spain

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GSK Investigational Site

Oviedo, 33006, Spain

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GSK Investigational Site

Palma de Mallorca, 07014, Spain

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GSK Investigational Site

Santander, 38008, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Hull, HU8 9HE, United Kingdom

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GSK Investigational Site

London, SE1 9RS, United Kingdom

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GSK Investigational Site

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Related Publications (10)

• 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.

  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.

  BACKGROUND

• 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.

  PMID: 34870327 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.

  PMID: 23715567 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.

  PMID: 23715562 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: May 28, 2002
• Primary Completion: July 19, 2011
• Study Completion: July 19, 2011
• Last Updated: January 2, 2020
• Results First Posted: February 25, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

BE (4); FR (2); DE (19); GR (3); ES (9); FI (2); IT (5); LA (2); LI (1); NL (2); NO (2); PL (6); GB (2)