Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
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.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.|
Biological: Lucanix® (belagenpumatucel-L)
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.