Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination 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.