NCT07704645尚未招募2 期
A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.
研究概览
简要总结
This study is an open-label, multicenter phase II clinical trial of adebelizumab combined with other anti-tumor therapies in patients with non-small cell lung cancer. The aim of this study was to evaluate the safety, tolerability and efficacy of adebelizumab combined with other anti-tumor therapies in patients with resectable non-small cell lung cancer ( NSCLC )
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
- •At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
- •The ECOG score was 0 or
- •Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection.
- •5.Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.
- •6.Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.
- •7.According to the RECIST v1.1 standard, subjects must have measurable target lesions examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first administration.
- •8.There is sufficient hematology and organ function, as defined by the results of laboratory tests, to be completed within 7 days prior to the first dose of treatment : 9.Women of childbearing age must have a serum pregnancy test within 7 days before the first administration, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use an efficient method of contraception from the date of signing the informed consent to at least 26 weeks ( female subjects ) or 14 weeks ( male subjects ) after the last administration.
排除标准
- •Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.
- •3.Have previously received systematic anti-tumor therapy for non-small cell lung cancer other than this study ( including clinical research drugs ) ; 4.Participants who had received or planned to receive local treatment such as chest radiotherapy or ablation ;
结局指标
主要结局
Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.
时间窗: All results are expected to be obtained in the last participant three months after surgery.
次要结局
- Event-free survival (EFS)(In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant)
- Disease-free survival (DFS) as assessed byinvestigator(In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant)
- Objective response rate (ORR): assessed by the investigator(In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant)
- Overall Survival (OS)(In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant)
研究者
研究点 (1)
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