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
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- ?Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix?) vs placebo.
研究概览
简要总结
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. ?Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix?) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity. ?Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity. Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and some instances circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function. Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year. After completion of study treatment, subjects are followed every 3 months for 1 year and then annually for 4 years. The study treatment period is for 2 years, followed by follow up of 5 years. It is expected that around 70 patients will be enrolled from India. The first patient was enrolled for the study in India on 13-Apr-2009
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •oSubjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements: Stage IIIA (T3N2 only) or Stage IIIB or Stage IV.
- •oSubjects 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.
- •oNot 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.
- •oSubjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
- •Signed informed consent.
- •oNot less than 18 years and not more than 75 years old.
- •oEstimated life expectancy of at least 12 weeks.
- •oPerformance status (ECOG) ≤
- •oAbsolute neutrophil count ≥ 1,500/mm
- •oHemoglobin ≥ 9 g/dL.
- •oPlatelet count ≥ 100,000/mm
- •oAlbumin levels ≥ 2.5 g/dL.
- •oBilirubin ≤ 1.5 times the upper limit of normal (ULN).
- •oAspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
- •oCreatinine ≤ 1.5 × ULN.
- •oAlkaline phosphatase ≤ 5 × ULN.
排除标准
- •oConcurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).oPrior splenectomy.oAny surgery involving general anesthesia < 4 weeks prior to study registration.oChemotherapy more than 4 months or less than 4 weeks prior to study registration.oSteroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, other investigational products or immunotherapy less than 4 weeks prior to study registration.oSubjects 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.oPainful bone metastases, or bone metastases that require immediate therapy.oSignificant 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.oKnown allergies to eggs or soy.oSignificant weight loss (≥ 10% body weight in preceding 6 weeks).oKnown HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).oSerious 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.oNCI CTC Grade 3 or 4 peripheral neuropathy at study registration.oPrior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.oHistory of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.oPregnant 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.oKnown active Epstein-Barr infection within ≤ 60 days of study registration.
结局指标
主要结局
?Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix?) vs placebo.
时间窗: The primary analysis time point for all outcome variables will be the time of the primary analysis | for overall survival.
次要结局
- Evaluate the progression free survival (PFS) of subjects treated with Lucanix compared to treatment within the Best Support Care (BSC)control group.(PFS and TTP will be analyzed using the same methods as described for the primary endpoint.PFS will be calculated from the date of randomization to the date of documented tumor)