NCT07003321招募中2 期
Study on Efficacy and Safety of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old; Both men and women are welcome;
- •Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens.
- •ECOG ratings of 0 or
- •Expected survival period ≥ 12 weeks.
- •At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
- •Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.
排除标准
- •Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- •There have been significant severe infections and major surgeries in the past 4 weeks
- •Existence of previous or concurrent malignant tumors
- •Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- •Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery within 7 days prior to the first administration of medication
研究组 & 干预措施
HRS-4508 tablet
Experimental
干预措施: HRS-4508 tablet (Drug)
结局指标
主要结局
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
时间窗: 2 years
Objective response rate (ORR)
时间窗: 1 year
次要结局
- Blood concentrations of HRS-4508(12 weeks)
- Duration of response (DoR)(1 year)
- Disease control rate (DCR)(1 year)
- Progression free survival (PFS)(1 year)
- Overall survival (OS)(2 years)
研究者
研究点 (1)
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