Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2023年12月20日最近更新: 2023年12月19日

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: 160
试验地点: 1
主要终点: 3-year event-free survival (EFS) rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.

研究设计

研究类型: Interventional
分配方式: 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: 否

入选标准

•The patient shall sign the Informed Consent Form.
•Aged 18 ≥ years.
•Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) confirmed by imageological examinations (CT, PET-CT or EBUS).
•Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or
•Life expectancy is at least 12 weeks.
•At least 1 measurable lesion according to RECIST 1.
•Patients with good function of other main organs (liver, kidney, blood system, etc.)
•Patients with lung function can tolerate surgery;
•Without systematic metastasis (including M1a, M1b and M1c);
•Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
•Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later).

排除标准

•Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
•Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
•With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
•Participants who are allergic to the test drug or any auxiliary materials;
•Participants with Interstitial lung disease currently;
•Participants with active hepatitis B, hepatitis C or HIV;
•Pregnant or lactating women;
•Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
•Participated in another therapeutic clinical study;
•Other factors that researchers think it is not suitable for enrollment.