Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: GSK 249553 vaccine; Placebo
Intervention description: Intramuscular injection, 13 doses; Intramuscular administration, 13 doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.