Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy

Inclusion Criteria:

* Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
* Stage IIIA (T3N2 only) or
* Stage IIIB or
* Stage IV.
* Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
* Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
* Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
* Signed informed consent.
* Not less than 18 years and not more than 75 years old.
* Estimated life expectancy of at least 12 weeks.
* Performance status (ECOG) ≤ 2.
* Absolute neutrophil count ≥ 1,500/mm3.
* Hemoglobin ≥ 9 g/dL.
* Platelet count ≥ 100,000/mm3.
* Albumin levels ≥ 2.5 g/dL.
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
* Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
* Creatinine ≤ 1.5 × ULN.
* Alkaline phosphatase ≤ 5 × ULN.

Exclusion Criteria:

* Concurrent systemic steroids \> 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
* Prior splenectomy.
* Any surgery involving general anesthesia \< 4 weeks prior to study registration.
* Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
* Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
* Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
* Painful bone metastases, or bone metastases that require immediate therapy.
* Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
* Known allergies to eggs or soy.
* Significant weight loss (≥ 10% body weight in preceding 6 weeks).
* Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
* Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
* NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
* Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
* History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
* Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Known active Epstein-Barr infection within ≤ 60 days of study registration.