Phase III Lucanixâ„¢ 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.