A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Safety (The occurrence of ≥3 grade AEs)
研究概览
简要总结
The purpose of this observational study is to evaluate the safety and efficacy of Adebrelimab Injection in extensive-stage small cell lung cancer (ES-SCLC) under real-world conditions. Specifically, the study aims to assess the treatment of Adebrelimab Injection across various subgroups of ES-SCLC patients. The goal is to provide information on treatment patterns and effectiveness in real-life settings, explore potential predictive or prognostic biomarkers, and preliminarily evaluate the pharmacoeconomic indicators of Adebrelimab Injection treatment for extensive-stage small cell lung cancer.
详细描述
This trial is a multicenter, non-interventional real-world study aimed at evaluating the safety and efficacy of Adebrelimab in the treatment of extensive-stage small cell lung cancer (ES-SCLC). The study plans to enroll 2000 patients with extensive-stage small cell lung cancer, collecting relevant information such as demographics, medical history, treatment regimens including Adebrelimab, clinical outcomes, and adverse events.
Patients who have already decided to receive Adebrelimab treatment before enrollment will be categorized into one of the following two cohorts based on their disease stage and prior treatments:
Cohort 1: First-line treatment for advanced stage Cohort 2: Second-line and beyond for advanced stage
The Adebrelimab-containing treatment regimen for each patient will be assessed and selected by the investigator, and some treatment regimens are provided in this protocol for reference. After patients discontinue Adebrelimab treatment, they will be followed up until death, loss to follow-up, withdrawal of informed consent/voluntary withdrawal, or study termination/closure, whichever occurs first.
As this is an observational study, treatments, procedures, visits, and examinations are based on the routine clinical experience of the attending physicians. The examinations listed in the protocol are recommended or for reference, with no mandatory requirements. The primary source of data for this study will be patients' routine medical records. During the period of Adebrelimab treatment, data on the administration regimen, routine examinations, adverse events, concomitant medications, and efficacy evaluations will be collected.
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
- •Patients must meet all of the following criteria to be eligible for inclusion in this study:
- •Voluntarily sign the informed consent form and agree to participate in the study.
- •Histopathologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- •Age ≥ 18 years.
- •Determined by the investigator to be eligible for Adebrelimab treatment.
排除标准
- •Patients with any of the following conditions are not eligible for inclusion in this study:
- •Evidence of being a pregnant or lactating female.
- •Currently receiving treatment as part of a blinded study protocol.
- •Any other condition that the investigator deems unsuitable for inclusion in the study.
研究组 & 干预措施
First-line treatment for advanced stage
Any first-line regiment including Adebrelimab for advanced stage ES-SCLC
干预措施: First-line Adebrelimab regiment for advanced stage ES-SCLC (Drug)
Second-line and beyond for advanced stage
Any Second- or later-line and regiment including Adebrelimab for advanced stage ES-SCLC
干预措施: Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC (Drug)
结局指标
主要结局
Safety (The occurrence of ≥3 grade AEs)
时间窗: From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab
The occurrence of ≥3 grade AEs
次要结局
- PFS(Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.)
- OS(Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.)
- DoR(Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.)
- ORR(Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.)
- DCR(Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.)
研究者
Ren Shengxiang
Prof.
Shanghai Pulmonary Hospital, Shanghai, China