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


N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

NR001-04

NCT ID:

NCT01279798

Start Date:

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • NSCLC
  • stage III or IV NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Innovative Research Center of California San Diego, California  92103