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 (PEARL)

This is an interventional treatment trial for Lung Cancer, Non-Small Cell focused on measuring Non-Small Cell Lung Cancer, Immunotherapy, Antigen-Specific Read More

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.