NCT07242274尚未招募3 期
A Multicenter, Randomized, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of JMKX001899 Versus Docetaxel in Previously Treated Patients With KRAS G12C-Mutant Advanced or Metastatic Non-Small Cell Lung Cancer
Jemincare1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2025年12月31日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a multicenter, randomized, open-label, phase 3 clinical trial designed to evaluate the efficacy and safety of JMKX001899 compared to docetaxel in patients with previously treated, KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC).
KRAS G12C mutation is present in a subset of NSCLC patients. While docetaxel is a standard chemotherapy option, JMKX001899 is an investigational, targeted therapy designed to selectively inhibit the KRAS G12C mutation. This trial aims to determine whether JMKX001899 offers a superior clinical benefit compared to standard chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed NSCLC.
- •Failure of at least one prior line of therapy for locally advanced/metastatic disease, that included a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
- •At least one measurable lesion as defined by RECIST version 1.1.
排除标准
- •Known concomitant presence of other oncogenic driver mutations or rearrangements with established targeted therapies .
- •Previous treatment with any KRAS G12C-targeted agent.
- •Prior docetaxel therapy in the locally advanced/metastatic setting.
研究组 & 干预措施
JMKX001899
Experimental
Orally, once daily
干预措施: JMKX001899 (Drug)
Docetaxel
Active Comparator
By IV infusion every 21 days
干预措施: Docetaxel (Drug)
结局指标
主要结局
PFS
时间窗: 1 year
Progression-Free Survival
次要结局
- OS(3 years)
- AE(from first dose to 28 days after the last dose)
研究者
研究点 (1)
Loading locations...
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