NCT07601048尚未招募3 期
A Randomized, Open-Label, Multicenter Phase III Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2026年6月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 试验地点
- 1
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HRS-7058 in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years old to 75 years old ( including both ends ), regardless of gender ;
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;
- •Histological specimens confirmed the presence of KRAS G12 C mutation ;
- •Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ;
- •At least one measurable lesion conforming to the definition of RECIST v1.1 standard ;
- •ECOG physical score 0-1 points ;
- •Expected survival time ≥ 12 weeks ;
- •Have adequate bone marrow and organ function
- •Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.
排除标准
- •Subjects with active central nervous system ( CNS ) metastasis ;
- •Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
- •Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;
- •Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ;
- •Have serious cardiovascular and cerebrovascular diseases
- •Severe infection occurred within 4 weeks before the first administration.
- •The first study of arterial / venous thrombosis events within 3 months before medication was conducted.
- •Have a history of immunodeficiency, including HIV test positive ;
- •There is active hepatitis B or hepatitis C ;
- •Subjects with active central nervous system ( CNS ) metastasis ;
研究者
研究点 (1)
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