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