Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Clinical efficacy based on the evaluation of objective tumor response rate (RR)
研究概览
简要总结
This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib, is based on following:
- The medical need for the better therapy for advanced NSCLC and limited efficacy of the currently available therapy in advanced NSCLC.
- Postulated association of relevant cell-signaling pathways targeted by everolimus with different aspects of oncogenesis, disease progression, and response/resistance to treatment.
- Effectiveness of everolimus and rapamycin in preclinical models of lung cancer
- Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced NSCLC.
There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus, may be one of the key changes accounting for different aspects of oncogenesis, disease progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes to logically manipulate the cell's regulatory pathways to enable control of tumor growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 advanced (unresectable or metastatic) NSCLC
- •Tissue sample of the metastatic or primary tumor available for pathology evaluation and molecular marker analyses
- •Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin, and who have documented evidence of tumor progression (Arm 1)
- •Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin as well as a small molecule EGFR inhibitor (as a separate regimen) with documented tumor progression despite at least 4 weeks therapy with either gefitinib or erlotinib (Arm 2)
排除标准
- •Concurrent therapy with agents used otherwise as anticancer therapy (for example, methotrexate for rheumatoid arthritis)
- •Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding 4 weeks
- •Chronic treatment with steroids or another immunosuppressive agent
- •Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
previously treated with chemotherapy only
patients previously treated with chemotherapy only (at most 2 prior regimens one of which must have been platinum-based) and no EGFRI
干预措施: RAD001 (Drug)
previously treated with chemotherapy + small
patients previously treated with chemotherapy (at most 2 prior regimens one of which must have been platinum-based) and with one small molecule EGFRI
干预措施: RAD001 (Drug)
结局指标
主要结局
Clinical efficacy based on the evaluation of objective tumor response rate (RR)
时间窗: until progressive disease or unacceptable toxicity.
次要结局
- To investigate potential molecular markers predictive of clinical effect(as long as patients are in the study)
- To assess additional clinical efficacy of RAD001(as long as patients are in the study)
- To assess the steady state levels of RAD001 in blood(as long as patients are in the study)
- To assess safety of RAD001 monotherapy(as long as patients are in the study)