Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).
详细描述
It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.
Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.
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
- •Male or female, age >= 18 years, with life expectancy of at least 12 weeks.
- •Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.
- •Subjected to driving genes examination including EGFR, ALK and ROS
- •Achieve complete response (CR)/partial response (PR)/stable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).
- •Total metastatic lesions is limited to five.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <=
- •Patients must have measurable disease according to the RECIST (version 1.1) criteria.
- •Adequate organ function as defined by the following criteria:
- •Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 upper limit of normal (ULN) in the absence of liver metastases or up to 5 ULN in case of liver metastases. Total bilirubin <= 1.5 ULN.
- •Bone marrow function: Granulocyte count >= 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin >= 80g/dl.
- •Renal function: serum creatinine <= 1.5 ULN or creatinine clearance >= 60 ml/min. (based on modified Cockcroft-Gault formula).
- •Adequate coagulating function.
- •For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Males must agree to use effective contraception during the study period and for at least 12 weeks after completion of the study treatment.
- •Written (signed) informed Consent to participate in the study.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.
- •Patients with PFS no more than 3 months. to first line theray.
- •Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- •Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.
- •Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.
- •Patients with any unstable systemic disease (including active infections, significant cardiovascular disease, any significant hepatic, renal or metabolic disease).
- •Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- •Nursing or lactating women.
- •Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- •Patients who has mental disorder or other disease that contribute to no compliance.
- •Unwilling to write informed consent to participate in the study.
- •Patients who is unwilling to accept the follow-up.
研究组 & 干预措施
local consolidative treatment
Patients will be referred to multiple disciplinary treatment discussion for the decision of local consolidative treatment to primary or metastatic lesions including surgery, radiotherapy or interventional therapy.
干预措施: local consolidative treatment (Other)
结局指标
主要结局
Progression free survival
时间窗: 8 months
month
次要结局
- Response rate(6 months)
- Lung Cancer Symptom Scale(12 months)
- overall survival(2 years)
研究者
Yi-Long Wu
Dr.
Guangdong Association of Clinical Trials