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