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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Biological: Lucanix® (belagenpumatucel-L)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, NSCLC, stage III or IV NSCLC