NCT02064491已完成2 期
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
Finnish Lung Cancer Group6 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Progression-free survival of the whole study population and in the strata 1-2
研究概览
简要总结
The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.
详细描述
A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.
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
- •Histologically confirmed stage IIIB/IV NSCLC.
- •Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
- •Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- •Performance status: WHO 0-2
- •Measurable disease according to RECIST 1.1
- •Patients must be able to comply with study treatments
- •Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
- •Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
- •Patient must be able to comply with the protocol
排除标准
- •RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
- •Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- •Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
- •Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
- •Patient with symptomatic central nervous system metastases
- •Patient has known active hepatitis B or C, or HIV infection
- •Pregnant or breastfeeding.
- •Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
研究组 & 干预措施
Erlotinib and Chemotherapy
Experimental
Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
干预措施: Erlotinib (Drug)
Erlotinib and Chemotherapy
Experimental
Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
干预措施: Chemotherapy (Drug)
Chemotherapy
Active Comparator
Chemotherapy for four to six cycles
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival of the whole study population and in the strata 1-2
时间窗: An expected average of 36 weeks after last subject enrolled into our study
次要结局
- Overall Response Rate(An expected average of 36 weeks after last subject enrolled into our study)
- Rate of non-progression at 9 and 18 weeks(18 weeks after date of randomization of a last patient)
- Overall Survival(An expected average of 52 weeks after last subject enrolled into our study)
- Safety and toxicity(An expected average of 52 weeks after last subject enrolled into our study)
研究者
研究点 (6)
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