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