NCT00676507CompletedPhase 3
Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- NovaRx Corporation
- Enrollment
- 532
- Locations
- 153
- Primary Endpoint
- Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.
Study Overview
Brief Summary
Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer.
Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer.
Detailed Description
Primary Efficacy Endpoints:
- Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.
Secondary Efficacy Endpoints:
- 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 BSC control group.
- Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the BSC control group.
- Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the BSC control group.
- Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC control group.
- Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the BSC control group.
- Adverse events of subjects treated with Lucanix™ will be compared to subjects in the control group.
Outline: This is a multicenter study. Subjects are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 an objective response (PR or CR) to 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 four weeks 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) ≤
- •Absolute neutrophil count ≥ 1,500/mm
- •Hemoglobin ≥ 9 g/dL.
- •Platelet count ≥ 100,000/mm
- •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.
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.
Outcomes
Primary Outcomes
Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.
Time Frame: 7 years
Secondary Outcomes
- Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Best Supportive Care control group.(3 years)
- Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group.(3 years)
- Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group.(3 years)
- Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group.(3 years)
- Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the Best Supportive Care control group.(7 years)
- Adverse events of subjects treated with Lucanix™ will be compared to subjects in the Best Supportive Care control group.(7 years)
- Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Best Supportive Care control group.(3 years)
Investigators
Study Sites (153)
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