GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: GSK1572932A Antigen-Specific Cancer Immunotherapeutic; Placebo Control
Intervention description: Intramuscular administration, 13 doses; Intramuscular administration, 13 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASCI; Immunotherapeutic; MAGRIT; Tumor antigen; Non-small-cell lung cancer; Adjuvant cancer therapy

Summary:

      The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic
      product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of
      their tumor. A course of 13 injections will be administered over 27 months. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patient with completely resected, pathologically proven stage IB, II or
             IIIA NSCLC.

          -  Written informed consent for MAGE-A3 expression screening on tumor biopsy has been
             obtained from the patient prior to shipment of the sample for expression testing
             (before or just after surgical resection), and written informed consent for the
             complete study has been obtained prior to the performance of any other
             protocol-specific procedure.

          -  Patient is ≥ 18 years of age at the time of signature of the first informed consent
             form.

          -  The patient's tumor shows expression of MAGE-A3 gene

          -  The surgical technique for resection of the patient's tumor is anatomical, involving
             at least a lobectomy or a sleeve lobectomy;

          -  The mediastinal lymph node sampling is done according to study protocol guidelines;

          -  The patient is free of metastasis, as confirmed by a negative baseline computer
             tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.

        Other examinations should be performed as clinically indicated. Note that if randomization
        is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4
        weeks before surgery do not have to be repeated.

          -  ECOG performance status of 0, 1 or 2 at the time of randomization.

          -  Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as
             assessed by standard laboratory criteria, and defined as:

        Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤
        1.5 times the Upper Limit of Normal (ULN)

        ≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times
        the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN

          -  If the patient is female, she must be of non-childbearing potential, i.e. have a
             current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is
             of childbearing potential, she must practice adequate contraception for 30 days prior
             to administration of study treatment, have a negative pregnancy test and continue such
             precautions during all study treatment period and for 2 months after completion of the
             injection series.

          -  In the view of the investigator, the patient can and will comply with the requirements
             of the protocol.

        Exclusion criteria

          -  The primary tumor was removed by segmentectomy or wedge resection.

          -  The patient shows any evidence of residual tumor after surgery.

          -  The patient has received any anti-cancer specific treatment, including radiotherapy,
             immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:

        For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma
        skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has
        been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy
        for the treatment of the current NSCLC is allowed between surgery and randomization.

          -  The patient has previous or concomitant malignancies at other sites, except
             effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
             effectively treated malignancy that has been in remission for over 5 years and highly
             likely to have been cured.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the study investigational product.

          -  The patient has an autoimmune disease such as, but not limited to, multiple sclerosis,
             lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.

          -  The patient requires concomitant treatment with systemic corticosteroids, or any other
             immunosuppressive agents.

        Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or
        inhaled corticosteroids for COPD or topical steroids is permitted.

          -  The patient has received a major organ allograft.

          -  The patient is known to be HIV-positive.

          -  The patient has an uncontrolled bleeding disorder.

          -  The patient has uncontrolled congestive heart failure or hypertension, unstable heart
             disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia
             at the time of enrolment.

          -  The patient needs home oxygenation.

          -  The patient has psychiatric or addictive disorders that may compromise his/her ability
             to give informed consent, or to comply with the trial procedures.

          -  The patient has other concurrent severe medical problems, unrelated to the malignancy,
             that would significantly limit full compliance with the study or expose the patient to
             unacceptable risk.

          -  The patient has received any investigational or non-registered medicinal product other
             than the study medication within the 30 days preceding the first dose of study
             medication, or plans to receive such a drug during the study period.

          -  For female patients: the patient is pregnant or lactating.