Evaluation of a New Anti-cancer Vaccine for Patients With Non-small Cell Lung Cancer, After Tumor Removal by Surgery

Inclusion Criteria

• •1. Male or female patient with completely resected (R0 resection), pathologically proven stage IB, II or IIIA NSCLC. Patients are allowed to receive adjuvant platinum-based chemotherapy for the treatment of the current NSCLC between surgery and enrolment.
• •2. Written informed consent for PRAME gene expression screening on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing, and written informed consent for the complete study participation has been obtained before the performance of any other protocol specific procedure.
• •3. Patient is \>= 18 years of age at the time of signature of the first informed consent form.
• •4. The patient's tumor shows expression of the PRAME gene.
• •5. The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy. The first ASCI administration will be given, either within 12 weeks after surgery or within 8 weeks after day 1 of last chemotherapy cycle and within 32 weeks after resection.
• •6. The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest and upper abdomen as well as CT scan or magnetic resonance imaging (MRI) of the brain. These tests are to be performed within 6 weeks for the CT scan of the chest and upper abdomen and within 12 weeks for the brain CT scan or MRI before first ASCI administration.
• •7. ECOG performance status of 0, 1 or 2.
• •8. Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria
• •9. Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal-ligation, hysterectomy, ovariectomy or post-menopause.
• •10. Female patient of childbearing potential may be enrolled in the study, if the patient:
• •* has practiced adequate contraception for 30 days prior to study product administration, and
• •* has a negative pregnancy test on the day of administration, and
• •* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
• •11. In the view of the investigator, the patient can and will comply with the requirements of the protocol.