A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.
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
- •Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
- •Patients must be non-smokers
- •Patients must have at least one measurable lesion
- •Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
- •Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.
排除标准
- •Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
- •Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
- •Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
- •Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
- •Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed
研究组 & 干预措施
Pemetrexed + Erlotinib
Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
干预措施: pemetrexed (Drug)
Pemetrexed + Erlotinib
Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
干预措施: erlotinib (Drug)
Erlotinib
Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
干预措施: erlotinib (Drug)
Pemetrexed
Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Randomization to measured PD up to 38 months
PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.
次要结局
- Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)](Randomization to measured disease progression up to 38 months)
- Overall Survival (OS)(Baseline to date of death from any cause up to 45.5 months)
- Number of Participants With Adverse Events(Randomization up to 39 months)
- Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)(Randomization to disease progression up to 38 months)
- Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)(Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months)
- Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status(Randomization to date of PD or death up to 38 months)
- Probability of OS at 12 Months(Month 12)