NCT04398940Unknown2 期
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 71
- 试验地点
- 16
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •Life expectancy ≥12 weeks;
- •MET-altered non-small cell lung cancer (NSCLC) ;
- •Has at least one measurable lesion;
- •Previous standard treatment has failed;
- •Adequate organ system function;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Understood and signed an informed consent form.
排除标准
- •Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration;
- •Has received c-MET inhibitors;
- •Has received other system anti-tumor treatment within 4 weeks before the first administration;
- •Has received major surgical treatment within 4 weeks before the first administration;
- •Has received radiotherapy or any surgery within 2 weeks before the first administration;
- •Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy;
- •Has active infection within 2 weeks before the first administration;
- •Has currently uncontrollable congestive heart failure;
- •Has currently uncontrollable congestive heart failure;
- •Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms;
- •Has uncontrollable effusion;
- •Has interstitial lung diseases;
- •Has severely unstable central nervous system metastasis;
- •Has active viral infection;
- •Has multiple factors affecting oral medication;
- •Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study;
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQ-B3139 capsules
Experimental
TQ-B3139 capsules administered orally.
干预措施: TQ-B3139 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR).
次要结局
- Progression-free survival (PFS)(up to 18 months)
- Duration of Response (DOR)(up to 18 months)
- Intracranial progression-free survival (CNS-PFS)(up to 18 months)
- Time to progress of intracranial disease (CNS-TTP)(up to 18 months)
- Overall survival (OS)(up to 24 months)
- Disease control rate (DCR)(up to 18 months)
- Intracranial objective response rate (CNS-ORR)(up to 18 months)
研究者
研究点 (16)
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