RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous Non-Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Describe the patient population and treatment patterns
研究概览
简要总结
The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a/m non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2024.
详细描述
The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with advanced/metastaic non-squamous NSCLC with or without AGA and who have failed platinum-based chemotherapy and immunotherapy (for patients without AGA) or platinum-based chemotherapy and at least 1 line of targeted therapy (for patients with AGA). The study will be conducted on one cohort of patients regardless their AGA status. The study index date will be defined as first dose of any agent after PTC, with specific treatments received for AGA and non-AGA patients in the preindex period. We will also conduct a subgroup analysis on NSCLC pre-defined subtypes (sample size permitting): EGFR mutant, ALK translocation, ROS1 translocation, MET1 mutant, HER-2 mutant, BRAF mutant, pan-wild-type PD-L1 >50%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Confirmed diagnosis of non-squamous NSCLC, Stage IIIB/IIIC incurable or IV/M
- •Age ≥ 18 years at diagnosis of advanced/metastatic disease.
- •AGA Cohort: Presence of actionable mutations and all of the following:
- •failure of platinum-based chemotherapy,
- •failure of ≥ 1 line of approved target therapy or no targeted therapy available at the clinic,
- •additional systemic treatment after platinum + target therapy combination.
- •Non-AGA Cohort: Absence of actionable mutations and all of the following:
- •failure of platinum-based chemotherapy,
- •failure of immunotherapy concurrent or sequential to platinum,
- •additional systemic treatment after platinum + immunotherapy combination.
排除标准
- •Patients with evidence of other primary malignancies (except basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both study cohorts.
- •Patients who participated in a clinical investigational study for the treatment of any cancer, including NSCLC, or any early access program from 2018 onwards.
结局指标
主要结局
Describe the patient population and treatment patterns
时间窗: between January 1st 2017 and December 31th 2024
Description of patient population and treatment patterns: tumor histology, mutation and PD-L1 status, disease stage at diagnosis
Describe the patient population and treatment patterns
时间窗: between January 1st 2017 and December 21th 2024
Description of patient population and treatment patterns: disease stage at diagnosis
Describe of the population and treatment patterns
时间窗: between January 1st 2017 and December 31th 2024
Description of patient population and treatment patterns: duration of therapy
次要结局
未报告次要终点