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

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ClinicalTrials.gov Identifier: NCT00290355
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

February 10, 2006
February 13, 2006
December 10, 2014
May 2002
July 2011   (Final data collection date for primary outcome measure)
Number of days from surgical resection to the recurrence of NSCLC (all types of recurrence will be included) [ Time Frame: At the time of analysis ]
Number of days from surgical resection to the recurrence of NSCLC (all types of recurrence will be included).
Complete list of historical versions of study NCT00290355 on ClinicalTrials.gov Archive Site
  • Recurrence [ Time Frame: 6, 12, 18, 24 and 30 months after enrolment ]
  • Disease-free survival [ Time Frame: At the time of analysis ]
  • Time to death [ Time Frame: At the time of analysis ]
  • Time to lung cancer death [ Time Frame: At the time of analysis ]
  • Lung-cancer-related death [ Time Frame: 30 months after enrolment ]
  • Antibodies to MAGE-3 and protein D [ Time Frame: At all points during treatment as specified in the study schedule ]
  • In vitro cellular immune response [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Serum level of Cyfra21.1 and CEA [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Level of plasma DNA and molecular characterisation by loss of heterozygosity and microsatellite instability [ Time Frame: At all points during treatment as specified in the study schedule. ]
  • Number of circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
  • MAGE-3 expression in circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Gene expression profiles of primary and relapsed tumour samples [ Time Frame: At the time of resection ]
  • Proteomes of the patients' plasma [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Solicited local and general signs and symptoms recorded by the patients on diary cards [ Time Frame: For a period of 7 days following each administration of vaccine/placebo ]
  • Unsolicited non-serious adverse events [ Time Frame: Reported at any time until 30 days following the most recent administration of vaccine/placebo ]
  • All serious adverse events [ Time Frame: At any time during the study ]
  • Haematological, biochemical and urinalysis parameters [ Time Frame: At regular intervals during the study ]
  • "For efficacy: Recurrence rates at several specific timepoints after enrolment; time to death; time to lung cancer death; lung-cancer-related death rate 30 months after enrolment.
  • Forimmunogenicity: Cellular and Humoral immune response against the vaccine
  • For safety and tolerability: Solicited local and general signs and symptoms; all other adverse events; haematological and biochemical tests and urinalysis."
Not Provided
Not Provided
 
Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Lung Cancer, Non-Small Cell
  • Biological: GSK 249553 vaccine
    Intramuscular injection, 13 doses
  • Biological: Placebo
    Intramuscular administration, 13 doses
  • Experimental: Vaccine Group
    Intervention: Biological: GSK 249553 vaccine
  • Placebo Comparator: Placebo Group
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
180
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Estonia,   Finland,   France,   Germany,   Greece,   Italy,   Latvia,   Lithuania,   Netherlands,   Norway,   Poland,   Spain,   United Kingdom
 
 
NCT00290355
249553/004
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP