A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
研究概览
简要总结
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.
Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
详细描述
Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC
Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Performance status 0-
- •Weight Loss < 10% in preceding 3 months
- •Age 18 years and older.
- •Adjuvant chemotherapy allowed if > 6 months from protocol entry
- •Adequate Organ Function
- •Liver enzymes < 2X normal, bilirubin = normal
- •Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
- •Creatinine <2.0 mg
排除标准
- •Not pregnant or lactating.
- •No Clinical Brain Metastases
- •No prior chemotherapy for systemic disease
- •Imminent need for chemotherapy for impending organ dysfunction is not allowed
研究组 & 干预措施
A
干预措施: Erlotinib (Tarceva) (Drug)
结局指标
主要结局
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
时间窗: 6 months
Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
次要结局
- Overall Survival(24 months)