NCT07829744尚未招募2 期
Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations
Shanghai Zhongshan Hospital0 个研究点目标入组 190 人开始时间: 2026年9月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 主要终点
- Major Pathological Response Rate
研究概览
简要总结
This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 stage III NSCLC (AJCC 8th edition), considered resectable or potentially resectable.
- •Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.
- •At least one measurable lesion per RECIST 1.1 and ECOG performance status 0-
- •Adequate cardiopulmonary and major organ function for surgery.
- •Written informed consent and willingness to comply with study procedures, sample collection, and follow-up.
排除标准
- •Stage III NSCLC considered unresectable by surgical assessment.
- •Lung cancer treatment within the previous 2 years, or prior lung cancer with a remission duration of less than 2 years.
- •Another malignancy within the previous 5 years.
- •Major surgery within 28 days before the first study dose.
- •Any contraindication to the assigned targeted therapy.
- •Inability or unwillingness to provide informed consent or comply with study requirements.
研究组 & 干预措施
ROS1 Fusion Cohort
Experimental
Entrectinib
干预措施: Surgical Resection (Procedure)
EGFR Exon 20 Insertion Cohort
Experimental
Sunvozertinib
干预措施: Surgical Resection (Procedure)
ALK Fusion Cohort
Experimental
Alectinib
干预措施: Surgical Resection (Procedure)
MET Exon 14 Skipping Cohort
Experimental
Tepotinib
干预措施: Surgical Resection (Procedure)
RET Fusion Cohort
Experimental
Selpercatinib
干预措施: Surgical Resection (Procedure)
KRAS G12C Mutation Cohort
Experimental
Fulzerasib
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Major Pathological Response Rate
时间窗: At surgery, approximately 10-12 weeks after treatment initiation.
次要结局
未报告次要终点
研究者
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