| Inclusion Criteria: | 1) Patients with completely resected, pathologically proven stage IB, II or IIIA NSCLC according to AJCC Version 6.0.
2) Written informed consent for MAGE-A3 expression screening and the gene expression signature testing on tumor biopsy has been obtained from the patient prior to shipment of the sample for MAGE-A3 expression testing and the gene expression signature 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.
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 MAGE-A3 gene; Note: Analysis will be performed on formalin-fixed paraffin-embedded tissue samples.
5) The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy.
6) The mediastinal lymph node sampling is done according to study protocol guidelines.
7) 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 brain CT scans or brain MRI performed no more than 12 weeks prior to first treatment administration do not have to be repeated unless clinically indicated (i.e., new clinical signs or symptoms suggestive of brain metastases).
8) ECOG performance status of 0, 1 or 2 at the time of randomization.
9) 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 10^9/L, Platelet count >/= 75 x 10^9/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.
10) 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.
11) In the view of the investigator, the patient can and will comply with the requirements of the protocol.
12) Patients who have undergone complete resection of appropriate stage NSCLC at an institution other than the study institution may be elligible for enrollment provided that they meet the above inclusion criteria and are enrolled within 4 - 12 weeks of the date of their surgery. |