Randomized Multicenter Study to Compare the Effectiveness and Safety of Erlotinib and Pemetrexed as Maintenance Therapy of Advanced Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms
研究概览
简要总结
The purpose of this multicenter randomized study is to compare the effectiveness and safety of erlotinib and pemetrexed in the maintenance treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)
详细描述
A randomized multi-center prospective study to compare the 12-month effectiveness (survival) and safety of erlotinib and pemetrexed as maintenance treatment in two groups of patients with locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology, whose disease has not progressed immediately following platinum-based chemotherapy for 4 cycles administered per routine daily practice in each study center
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
- •Age ≥18 years
- •Signed written informed consent
- •Histologically or cytological diagnosed stage IIIB/IV non-squamous histology NSCLC
- •Received platinum based doublet chemotherapy for 4 cycles as first line therapy before this study
- •Patients upon enrolment has at least stable disease following the platinum doublet; with documented (confirmed or unconfirmed) radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1 criteria
- •Estimated Life expectancy ≥ 3 months
- •Eastern cooperative oncology group performance status (ECOG PS) 0-2
- •Adequate organ function
排除标准
- •Age ˂18 years
- •Predominantly squamous cell and/or mixed small cell, non-small cell histology
- •Current treatment on another therapeutic clinical study or within the last 30 days of entering the study
- •Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
- •Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack
- •Ongoing cardiac dysrhythmias of national cancer institute-common terminology criteria for adverse events (NCI CTCAE) Grade >2, uncontrolled atrial fibrillation of any grade, or corrected QT interval (QTc) >470 msec
- •Pregnancy or breastfeeding
- •Prior malignancy (other than current NSCLC): patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer) within the last 3 years
- •Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impose, in the judgment of the investigator and/or sponsor, excessive risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate to enter this study
- •Uncontrolled third-space fluid collections
- •Progressive brain metastases
- •Hypersensitivity to the study drugs
- •Inability to take corticosteroid drugs, folic acid, or vitamin B12
- •Patients with epidermal growth factor receptor (EGFR) positive, anaplastic lymphoma kinase (ALK) positive (documented using fluorescence in situ hybridization (FISH) and/or immunohistochemistry (IHC)), or unknown EGFR and ALK test results
研究组 & 干预措施
Pemetrexed Arm
Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium)
干预措施: Pemetrexed (Drug)
Erlotinib Arm
Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride)
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms
时间窗: 12 months
Progression Free Survival is defined as the time from date of randomization to the date of tumor progression or death from any cause, assessed until at least 12 months after randomization. Progression is defined using response evaluation criteria in solid tumors (RECIST version 1.1)
次要结局
- Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy(12 months)
- Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms(12 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed(12 months)