A Phase II, Open-label Study to Evaluate the Efficacy and Safety of HMPL-504 in Locally Advanced/Metastatic MET-Mutation-Positive Pulmonary Sarcomatoid Carcinomas and Other Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- To assess objective response rate (ORR)
研究概览
简要总结
This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.
详细描述
Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.
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
- •1.Fully understood the study and voluntarily signed Informed Consent Form
- •2.Age > 18 years
- •3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
- •4.Patient should have measurable disease per RECIST1.1
- •5.ECOG performance status of 0, or 1
- •6.Expected survival > 12 weeks
排除标准
- •1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
- •2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
- •3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
- •4.Herbal therapy within 1 week prior to the initiation of study treatment
- •has EGFR, ALK or ROS 1 positive mutation
研究组 & 干预措施
Savolitinib
Pulmonary Sarcomatoid Carcinomas
干预措施: Savolitinib (Drug)
结局指标
主要结局
To assess objective response rate (ORR)
时间窗: 1year
ORR is defined as the proportion of patients with complete response or partial response. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks and in this study, it could be performed by the scheduled tumor assessment 6 weeks later
次要结局
- Progression free survival(PFS)(1year)
- Safety Assessment Parameter(1year)