NCT05241028招募中2 期
Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate (DFSR)
研究概览
简要总结
This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).
- •Males or females aged ≥18 years, ≤75 years.
- •ECOG performance status 0-
- •Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments).
- •Clinical examinations before treatment report no signs of disease recurrance.
- •With enough tumor histology specimens (non-cytology) for molecular marker analysis.
- •hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L.
- •Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN;
- •Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min;
- •Signed inform consent form by patient or his/her legal representative.
- •Comply with study protocol and procedure, and be able to take oral medication.
- •Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment.
- •Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy.
排除标准
- •Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past.
- •Having local radiotherapy of NSCLC.
- •Known allergy to Ensatinib or any of the ingredients in this product.
- •Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis.
- •Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases.
- •Women who are pregnant or breastfeeding.
- •Having history of neurological or psychiatric disorders, including epilepsy or dementia.
- •Other conditions investigators evaluate that patient is not eligible to this study.
研究组 & 干预措施
Ensartinib
Experimental
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
干预措施: Ensartinib (Drug)
结局指标
主要结局
3-year disease free survival rate (DFSR)
时间窗: 3 years
Defined as the percentage of patients alive and disease free at 3 years
次要结局
- Adverse Events(Up to 3 years)
- 5-year overall survival rate(5 years)
- disease free survival (DFS)(Up to 5 years)
- overall survival (OS)(Up to 5 years)
研究者
LiuJunFeng
Director of thoracic surgery
Hebei Medical University Fourth Hospital
研究点 (1)
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