Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.
详细描述
All EGFR mutation NSCLC patients with EGFR-TKIs eventually develop acquired resistance and in 40%-50% of these the resistance mechanism is based on the EGFR T790M mutation who could receive Osimertinib. Several alternative mechanisms of escape from EGFR-TKIs have been detected in NSCLC patients without the T790M, such as Met application, BRAF mutation, PIK3CA mutation, etc, who could receive the combination of EGFR-TKI with comparable target drug. Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. In the present study, we aimed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >=18 years of age
- •Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
- •EGFR-TKI resistent
- •EGFR T790M negative
- •Expected survival ≥ 3 month;
- •ECOG / PS score: 0-2;
- •the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
排除标准
- •EGFR-T790M positive
- •with druggable gene alteration;
- •Patient can not comply with research program requirements or follow-up;
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Time from treatment beginning until disease progression
Objective Response Rate
时间窗: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
次要结局
- Adverse Effect(Through study completion, an average of 1 months)
- Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months)
研究者
Baodong Qin
Clinical Resident
Shanghai Changzheng Hospital