Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.

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