TRIMPACT: A Prospective Real-World Study of Atezolizumab Monotherapy as First-Line (Stage IV) Treatment in Patients With Non-Small Cell Lung Cancer With PD-L1 Tumor Cell Expression ≥50% and No Targetable Mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This prospective, multicenter, real-world observational study aims to evaluate the clinical outcomes of first-line atezolizumab monotherapy in patients with stage IV non-small cell lung cancer (NSCLC) with PD-L1 tumor cell expression ≥50% and no targetable mutations. The study aim to determine how atezolizumab performs in routine clinical practice with respect to survival, treatment response, and safety outcomes in this patient population in Türkiye.
详细描述
This study is a prospective, multicenter, observational study designed to generate real-world evidence on the routine first-line use of atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) who exhibit high PD-L1 expression and have no targetable mutations. The study does not impose any protocol-mandated procedures or intervention requirements, and all assessments, treatments, and follow-up visits are carried out according to local standards of care at each participating center.
Data will be collected prospectively from routine medical records and will include information typically obtained during standard clinical management, such as imaging assessments, laboratory results, performance status evaluations, treatment exposure, and safety monitoring. Clinical outcomes will be analyzed to describe real-world treatment patterns, variations in clinical practice, and survival and safety trends in a national cohort. Approximately 150 patients are expected to be enrolled to ensure adequate precision in estimating long-term outcomes within this population.
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
- •Signed informed consent form.
- •Diagnosis of stage IV non-small cell lung cancer.
- •Male or female patients aged 18 years or older.
- •Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.
- •Patients who have received up to 3 cycles of atezolizumab at the screening visit.
排除标准
- •Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.
- •Known or suspected hypersensitivity to atezolizumab.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 24 months
Overall survival (OS) is defined as the time from the initiation of atezolizumab treatment to the date of death from any cause.
次要结局
- Progression-Free Survival (PFS)(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)
- Disease Control Rate (DCR)(Up to 24 months)
- Duration of Response (DoR)(Up to 24 months)
- One-year Overall Survival (1-year OS)(12 months)
- Incidence of Hyperprogression(Up to 24 months)
- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)(Up to 24 months)
研究者
Derya Kivrak salim
Associate Professor
Antalya Training and Research Hospital