Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)

Inclusion Criteria: * Signed informed consent * ≥ 18 years * Histological confirmed non-curable stage III or IV NSCLC. * Must have completed at least one (1) regimen of anti-cancer therapy. * Following frontline therapy, subjects must observe the following wash- out periods: * Subjects with stable disease or better must have received the last anti-cancer therapy not less than five months prior to enrollment. * Subjects with progressive disease must have received the last anti-cancer therapy at least one (1) month prior to enrollment. * All subjects who have received two (2) or more regimens of therapy must have received the last anti-cancer therapy at least one (1) month prior to enrollment. * Performance status (ECOG) ≤ 2 * Absolute granulocyte count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Total Bilirubin ≤ 2× Upper Limit of Normal * AST and ALT ≤ 2× Upper Limit of Normal * Creatinine ≤ 2× Upper Limit of Normal * Negative pregnancy test for women of childbearing potential. Exclusion Criteria: * Concurrent systemic steroids \> 2 mg prednisone/day * Prior splenectomy * Any chemotherapy, steroid therapy, or investigational anti-cancer agent within 4 weeks of study entry. * Subjects who received prior monotherapy with Lucanix. * Symptomatic brain metastases unless treated and stable for ≥ 2 months * Known HIV positivity * Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives. * Prior malignancy (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years * History of psychiatric disorder that would impede adherence to protocol * Pregnant or nursing women or refusal to practice contraception if of reproductive potential