Trials / No Longer Available
No Longer AvailableNCT01279798
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer.
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- NovaRx Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Lucanix® (belagenpumatucel-L) | Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection. |
Timeline
- First posted
- 2011-01-19
- Last updated
- 2011-03-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01279798. Inclusion in this directory is not an endorsement.