Sacituzumab Tirumotecan and Limertinib for Conversion Therapy in Locally Advanced Potentially Resectable EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Single-arm, Exploratory Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
This study is a prospective, single-arm, exploratory clinical research aimed at evaluating the efficacy and safety of lucetamab in combination with leucovorin in the conversion therapy of locally advanced potentially resectable EGFR mutation-positive non-small cell lung cancer, providing more robust clinical evidence for the improvement of treatment modalities for EGFR-mutated locally advanced NSCLC. At the same time, it seeks to identify biomarkers that can predict the therapeutic effect of the combination of lucetamab and leucovorin, offering more precise guidance for the selection of clinical treatment plans and enabling patients to receive the optimal treatment regimen.
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
- •Sign the informed consent form
- •The age of the subjects is over 18 years old
- •Patients with non-small cell lung cancer (NSCLC) with EGFR mutation confirmed by pathology
- •Confirmed as locally advanced NSCLC (IIIA, IIIB, IIIC) by chest CT, PET-CT or/and EBUS, and MDT discussion concludes that immediate local surgery is not suitable
- •Have not received systematic anti-tumor treatment before
- •The researcher confirms at least one measurable lesion according to RECIST 1.1 criteria
- •Good lung function and able to tolerate surgical treatment
- •ECOG score is 0 to 1
排除标准
- •Allergy to Sacituzumab Tirumotecan or any of its excipients
- •Patients allergic to Limertinib or any of its excipients
- •Patients with a history of other primary tumors; patients with a history of allogeneic organ transplantation
- •Major surgery within 4 weeks before the first dose (excluding diagnostic biopsy)
- •Patients with drug addiction such as drug abuse, long-term alcohol abuse, AIDS or HIV carriers
- •Patients with active or previously had and may recur autoimmune diseases
- •Currently receiving systemic hormone therapy (such as equivalent to more than 10 mg of prednisone per day or any other form of immunosuppressive therapy within 14 days before the first dose)
- •Patients who have received any EGFR-TKI or TROP2 ADC treatment before
研究组 & 干预措施
Surgical treatment after targeted therapy combined with chemotherapy
干预措施: Sacituzumab Tirumotecan and Limertinib (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: Perioperative
次要结局
- Major pathologic response (MPR) rate(Perioperative)
- Objective response rate (ORR)(Up to 3 months)
- Event-free suvival (EFS)(Up to 60 months)
- Overall suvival (OS)(Up to 60 months)
- R0 resection rate(Perioperative)
- Incidence of treatment discontinuation due to AE/SAE(Up to 3 months)
- Treatment-related adverse event (TRAE)(Up to 3 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China