NCT04056572Unknown2 期
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy ≥12 weeks.
- •Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
- •Has progressive disease during or after crizotinib treatment.
- •Has a measurable disease.
- •Adequate organ system function.
- •Understood and signed an informed consent form.
排除标准
- •Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
- •Hypersensitivity to TQ-B3139 capsule.
- •Has received ALK TKIs other than crizotinib.
- •Has received any cancer therapy within 4 weeks or 5 times of t1/
- •Has received major surgery within 4 weeks.
- •Has received any radiotherapy or minor surgery within 2 weeks.
- •Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
- •Has active viral, bacterial and fungal infections within 2 weeks.
- •Has serious cardiovascular diseases.
- •Has currently uncontrollable congestive heart failure.
- •Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval > 480ms.
- •Has interstitial fibrosis or interstitial lung disease.
- •Brain metastases with symptom or carcinomatous meningitis.
- •Has active hepatitis B or hepatitis C.
- •Has multiple factors affecting oral medication.
- •Breastfeeding or pregnant women.
- •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
Experimental
TQ-B3139 tablet 600mg administered orally, twice daily.
干预措施: TQ-B3139 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 36 months
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
次要结局
- Progression-free survival (PFS)(up to 36 months)
- Disease control rate (DCR)(up to 36 months)
- Overall survival (OS)(up to 36 months)
研究者
研究点 (2)
Loading locations...
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