Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Major Pathologic Response (MPR) Rate
研究概览
简要总结
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed non-small cell lung cancer (NSCLC).
- •ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.
- •Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
- •ECOG Performance Status of 0-
- •At least one measurable lesion according to RECIST 1.
- •Adequate organ and marrow function.
排除标准
- •Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
- •Prior treatment with ALK TKI or ROS1 TKI.
- •Prior treatment with local radiotherapy.
- •Mixed small cell and NSCLC histology.
- •Patients who are candidates to undergo only segmentectomies or wedge resections.
研究组 & 干预措施
WX-0593
The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression.
干预措施: WX-0593 Tablets (Drug)
结局指标
主要结局
Major Pathologic Response (MPR) Rate
时间窗: At time of surgery
Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.
次要结局
- Disease Control Rate (DCR)(Prior to surgery)
- Event-free survival (EFS)(3 years postoperatively)
- Pathologic Complete Response (pCR) Rate(At time of surgery)
- Resectability rate(At time of surgery)
- R0 Resection rate(At time of surgery)
- Objective Response Rate (ORR)(Prior to surgery)
- Disease-free survival (DFS)(3 years postoperatively)
- Overall Survival (OS)(3 years postoperatively)
研究者
Pingping Song
Department director
Shandong Cancer Hospital and Institute