A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 16
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
详细描述
This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung adenocarcinoma
- •At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
- •Suitable for conventional single agent chemotherapy
- •Disease progression at study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered
- •Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable
- •Adequate laboratory parameters
- •Willing and able to comply with the protocol and sign informed consent
- •Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation
排除标准
- •Received systemic anticancer therapy or radiation therapy within the previous 14 days
- •Received more than 3 lines of prior conventional therapy for advanced disease
- •Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy
- •Any condition requiring concurrent systemic immunosuppressive therapy
- •Known immunodeficiency disorders
- •Known leptomeningeal disease
- •Other active malignancies
- •Prior treatment with a cancer vaccine for this indication
- •Pregnant or breastfeeding
研究组 & 干预措施
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
干预措施: Viagenpumatucel-L (Drug)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
干预措施: Metronomic Cyclophosphamide (Drug)
Chemotherapy Alone
Patients will be treated with a physician's choice regimen until progression.
干预措施: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 3 years
Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive. Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
次要结局
- Progression-Free Survival (PFS)(Up to 3 years)
- Time to Progression (TTP)(Up to 3 years)
- Survival at 6 Months(6 months)
- Survival at 12 Months(12 months)
- Immune Response(Up to 3 years)
- Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)(Up to 3 years)
- Disease Control Rate (DCR)(Up to 3 years)
- 6-Month Disease Control Rate (6mDCR)(6 months)
- Overall Response Rate (ORR)(Up to 3 years)