Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT01279798
- Lead Sponsor
- NovaRx Corporation
- Brief Summary
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.
- Detailed Description
The primary objective of this study is to increase the overall survival of the study subjects by providing expanded access to Lucanix. Overall survival and progression-free survivals will be compared with historical controls.
The secondary objectives of this study are:
* Evaluate the best overall tumor response.
* Evaluate progression-free survival (PFS).
* Evaluate treatment toxicity.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
-
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 potential
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Innovative Research Center of California
🇺🇸San Diego, California, United States