A Study to Demonstrate the Benefit of a New Kind of Anti-cancer Treatment [PReferentially Expressed Antigen of MElanoma (PRAME) Immunotherapy] for Patients With Non-Small Cell Lung Cancer (NSCLC), After Removal of Their Tumor
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A; Placebo
Intervention description: Intramuscular administration; Intramuscular administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Immunotherapy; Antigen-Specific

Summary:

      The purpose of this study was to test a potential new kind of anti-cancer treatment, called
      PRAME immunotherapy in resected patients with lung cancer.

      Based on scientific and medical relevance, the clinical study was ended on 24 August 2016.
      The participants were no longer enrolled in the study, the follow ups on subjects were
      stopped and the collection and analysis of samples for further research purposes was stopped.

      After the stop to recruitment, the study was unblinded, as per the amended protocol, the
      study treatment was continued and completed with the subjects of the active treatment group
      who were willing to continue. Subjects in the placebo group were withdrawn.

      There was no longer an active follow-up of patients after discontinuation or completion of
      the treatment. The study ended 30 days after the last dose was administered.

      As a result, primary and secondary objectives were not assessed as planned. All clinical and
      safety data collected in the study were analysed descriptively. For each biological sample
      already collected in the scope of this study and not tested yet, testing was not performed by
      default, except if a scientific rationale remained relevant despite the premature termination
      of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has radically resected NSCLC

          -  The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique
             for resection of the patient's tumor is anatomical, involving at least a segmentectomy
             The patient's tumor shows expression of PRAME.

          -  The patient is ≥ 18 years of age at the time of first consent.

          -  Written informed consent has been obtained from the patient prior to performance of
             any study-specific procedure.

          -  The patient is free of disease (no residual tumor, no loco-regional recurrence, no
             distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced
             computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced
             CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be
             performed as clinically indicated.

          -  Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the time
             of randomization

          -  Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed
             by standard laboratory criteria

          -  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 product, have a negative pregnancy test and continue such
             precautions during all study treatment period and for 2 months after last treatment
             administration.

          -  Patients who the investigator believes can and will comply with the requirements of
             this protocol (e.g. return for active follow-up visits).

        Exclusion Criteria:

          -  The patient is diagnosed with a concomitant malignancy and/or has a history of
             malignancy within the past five years or has had a malignancy that has been in
             complete remission for less than 5 years. Patients with effectively treated non -
             melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of
             which in remission for less than 5 years will be eligible.

          -  The patient has received any anti-cancer specific treatment, including radiotherapy,
             immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except
             for:

               -  Administration of adjuvant platinum-based doublet chemotherapy for the treatment
                  of the current NSCLC allowed between surgery and randomization.

               -  Treatment of previous malignancies as allowed by the protocol.

          -  The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD).
             Patients with vitiligo are not excluded from the study.

          -  The patient has a history of confirmed adrenal dysfunction.

          -  The patient requires concomitant treatment with any immunosuppressive agent, or with
             systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive
             days).

          -  The patient needs chronic long term oxygen therapy (LTOT). The patient has medically
             uncontrolled congestive heart failure or hypertension, unstable heart disease or
             uncontrolled arrhythmia at the time of randomization.

          -  The patient has an uncontrolled bleeding disorder.

          -  The patient has undergone splenectomy.

          -  The patient is known to be Human Immunodeficiency Virus (HIV)-positive.

          -  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 a history of allergic disease or reactions likely to be exacerbated by
             any component of the study investigational product.

          -  The patient has received any investigational or non-registered product within the 30
             days preceding randomization, or planned use during the study period.

          -  For female patients: the patient is pregnant or lactating or is planning to become
             pregnant.