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

NO_LONGER_AVAILABLE

Conditions studied: Non-small Cell Lung Cancer

In brief

This is an expanded access protocol designed to make Lucanix® available to subjects with advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol, NR001-03. A total of 45 patients will be enrolled into the study.

Key facts

Study ID

NCT01279798

Run by

NovaRx Corporation

Last updated by the study team

2011-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Innovative Research Center of California — San Diego, California, United States

Full record on ClinicalTrials.gov

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