A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.
详细描述
Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Lung adenocarcinoma
- •Wld-type EGFR
- •Stage IIIB/IV
- •Failure to prior chemotherapy
- •Life expectancy of more than 3 months
- •Tissue sample desired for genomic study
- •Age ≥ 18 years
- •Performance status (WHO) < 3
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- •Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- •Informed consent
排除标准
- •Have previously received pemetrexed or TKIs
- •Other concurrent uncontrolled illness
研究组 & 干预措施
Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression.
干预措施: Erlotinib (Drug)
Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Best Tumor Response(From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.)
- Overall Survival(From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.)
研究者
Si-Yu Wang
Professor
Sun Yat-sen University