LBCTR2022055019暂停3 期
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer - KontRASt-02
ovartis Pharmaceuticals0 个研究点目标入组 8 人开始时间: 2024年5月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- All
入选标准
- •Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- •- Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
- •- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- •- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
排除标准
- •- Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor
- •- Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing
- •- Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •- Participant has an history of interstitial lung disease or pneumonitis grade > 1.
研究者
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