Non Small Cell Lung Cancer MedDRA version: 14.1 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Lucanix
Pharmaceutical Form: Injection
INN or Proposed INN: belagenpumatucel-L
Current Sponsor code: Lucanix
Other descrip
Sponsors
NovaRx Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for registration into the protocol are: -Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements: -Stage IIIA (T3N2 only) or -Stage IIIB or -Stage IV. -Subjects must have stable disease (SD) or better following a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy. -Not less than one month nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study. -Subjects treated for brain metastasis(es) are eligible if they have been stable for = 2 months. -Signed informed consent. -Not less than 18 years and not more than 75 years old. -Estimated life expectancy of at least 12 weeks. -Performance status (ECOG) = 2. -Absolute neutrophil count = 1,500/mm3. -Hemoglobin = 9 g/dL. -Platelet count = 100,000/mm3. -Albumin levels = 2.5 g/dL. -Bilirubin = 1.5 times the upper limit of normal (ULN). -Aspartate transaminase (AST) and Alanine transaminase (ALT) = 1.5 × ULN. -Creatinine = 1.5 × ULN. -Alkaline phosphatase = 5 × ULN. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone). -Prior splenectomy. -Any surgery involving general anesthesia < 4 weeks prior to study registration. -Chemotherapy more than 4 months or less than 4 weeks prior to study registration. -Steroid therapy (excluding = 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration. -Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for = 2 months. -Painful bone metastases, or bone metastases that require immediate therapy. -Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry. -Known allergies to eggs or soy. -Significant weight loss (= 10% body weight in preceding 6 weeks). -Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV). -Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives. -NCI CTC Grade 3 or 4 peripheral neuropathy at study registration. -Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for = 2 years. -History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements. -Pregnant or nursing women, or refusal to practice contraception if of reproductive potential. -Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. -Known active Epstein-Barr infection within = 60 days of study registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate Lucanix treatment of subjects with stages IIIA (T3N2 disease only), IIIB, or IV non-small cell lung cancer (NSCLC) who have stable disease (SD), or better (based on a comparison between the post-initiation chemotherapy scan and the baseline scan) following a frontline platinum-based chomotherapy regimen.; Secondary Objective: The Secondary objectives of the study are to -Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group. -Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Placebo control group. -Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Placebo control group. ;Primary end point(s): The primary efficacy endpoint of this international study is to evaluate the ability of Lucanix™ to significantly prolong the overall survival of subjects with stages IIIA (T3N2 disease only), IIIB, or IV non-small cell lung cancer (NSCLC) who have stable disease (SD) or better (based on a comparison between the post-initiation chemotherapy scan and the baseline scan) following a frontline platinum-based chemotherapy regimen by at least 3 months (92 days) when compared to subjects on the control arm | — |
Countries
Germany, Hungary, Netherlands, United Kingdom
Outcome results
None listed