The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients: A Real-world Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 845
- 主要终点
- 1-year Progression-Free Survival (PFS) rate
研究概览
简要总结
This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.
详细描述
This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice. Clinical treatment of patients will not be intervened unless disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances deemed appropriate by the investigator to discontinue treatment, whichever occurs first. The primary objective of the study is for investigators to assess the one-year progression-free survival (PFS) rate of immunotherapy as first-line treatment in PD-L1 negative advanced or metastatic NSCLC, evaluated according to RECIST 1.1 criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent must be obtained before implementing any trial-related procedures;
- •Aged 18-80 years;
- •Wild-type EGFR/ALK;
- •Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- •PD-L1 negative；
- •Patients receiving first-line immunotherapy (such as PD-1/PD-L1 inhibitors).
排除标准
- •The patient refused to join this study and declined follow-up.
研究组 & 干预措施
immunotherapy group
advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice
干预措施: PD-1 Inhibitors (Drug)
结局指标
主要结局
1-year Progression-Free Survival (PFS) rate
时间窗: up to 12 month
The 1-year Progression-Free Survival (PFS) rate is a clinical metric used to measure the percentage of patients who are still alive and have not experienced disease progression one year after the start of treatment.
次要结局
- Overall Survival(up to 36 months)
- Objective Response Rate(up to 9 month)
- Progression-Free Survival(up to 24 months)
研究者
Chunxia Su
Director of Clinical Research Center, Shanghai Pulmonary Hospital
Shanghai Pulmonary Hospital, Shanghai, China