A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
- •Failure of previous treatment with one prior platinum-based chemotherapy regimen.
- •Good performance status.
- •Adequate bone marrow reserve, renal and hepatic functions.
排除标准
- •Serious concomitant systemic disease.
- •Inability to take oral medication.
- •Inability or unwillingness to take vitamin supplementation and corticosteroids.
- •Pregnancy / Breast-feeding.
- •Treatment with certain medicines that prevent blood from clotting.
研究组 & 干预措施
Pemetrexed (Nonsquamous)
Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm
干预措施: Pemetrexed (Drug)
Pemetrexed + Erlotinib (Nonsquamous)
Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm
干预措施: Erlotinib (Drug)
Pemetrexed + Erlotinib (Nonsquamous)
Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm
干预措施: Pemetrexed (Drug)
Pemetrexed (Squamous)
Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm
干预措施: Pemetrexed (Drug)
Pemetrexed + Erlotinib (Squamous)
Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm
干预措施: Pemetrexed (Drug)
Pemetrexed + Erlotinib (Squamous)
Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.
次要结局
- Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)(Baseline to measured PD. Maximum follow-up was from Baseline to 34 months)
- Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)(Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months)
- Time to Treatment Failure (TTTF)(Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months)
- Overall Survival (OS)(Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.)
- Percentage of Participants Surviving at 1 Year(Baseline to date of death from any cause up to 1 year)
- Number of Participants With Adverse Events (AEs)(Baseline up to 42.2 months)