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

NCT ID: NCT00290355

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-28
• Study Completion Date: 2011-07-19

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.

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.

Conditions

Lung Cancer, Non-Small Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

GSK 249553 vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, 13 doses

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular administration, 13 doses

Interventions

GSK 249553 vaccine

Intramuscular injection, 13 doses

Intervention Type: BIOLOGICAL

Placebo

Intramuscular administration, 13 doses

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Pessac, , France

GSK Investigational Site

Rennes, , France

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ebensfeld, Bavaria, Germany

GSK Investigational Site

Gauting, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Offenbach, Hesse, Germany

GSK Investigational Site

Delmenhorst, Lower Saxony, Germany

GSK Investigational Site

Hemer, North Rhine-Westphalia, Germany

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

GSK Investigational Site

Kaiserslautern, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

GSK Investigational Site

Bad Berka, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Marousi, , Greece

GSK Investigational Site

Rio-Patras, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Pordenone, Friuli Venezia Giulia, Italy

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Perugia, Umbria, Italy

GSK Investigational Site

Venezia, Veneto, Italy

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Rigas Rajons, , Latvia

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Nijmegen, , Netherlands

GSK Investigational Site

Oslo, , Norway

GSK Investigational Site

Trondheim, , Norway

GSK Investigational Site

Chęciny, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Tuszyn, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Zakopane, , Poland

GSK Investigational Site

A Coruña, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Oviedo, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Santander, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Hull, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

, ,

Countries

Belgium; Estonia; Finland; France; Germany; Greece; Italy; Latvia; Lithuania; Netherlands; Norway; Poland; Spain; United Kingdom

References

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).

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 34870327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23715567 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23715562 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

249553/004

Identifier Type: -

Identifier Source: org_study_id