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临床试验/NCT07829744
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

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

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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