NCT06245837进行中（未招募）不适用
Multicenter, Non-interventional, Observational Study of Treatment and Biomarker Testing Patterns, Treatment Outcomes in Advanced/Metastatic NSCLC With and Without Actionable Genomic Alterations in Routine Clinical Practice in Russia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
研究概览
简要总结
Planned study population consists of approximately 1500 adult patients with a/m NSCLC in Russia, in about 20 oncological centers (in each center it is expected to recruit about 75 patients) in different regions of Russia in order to provide representative study sample
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morphologically confirmed NSCLC with or without actionable genomic alterations (AGA, i.e. EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, ERBB2 (HER2), or KRAS)
- •Age ≥18 years at the time of NSCLC diagnosis;
- •Locally advanced or metastatic disease defined as incident stage IIIB/IIIC/IV NSCLC or stage I-IIIA then progressed to stage IIIB-IV disease and not eligible for curative-intent treatment (the date of progression is included in the database);
- •Available data on at least one line of systemic therapy for advanced/metastatic disease within the period since January 2022 until January 2025;
- •Patients may be alive or deceased at the time of medical record abstraction
排除标准
- •Patients participated or participating in clinical trials or any early access program within period since the index date until the end of study period;
- •Diagnosis of another cancer (except for melanoma/skin cancer) at or within 5 years prior to NSCLC diagnosis or any ongoing systemic anti-cancer therapy regimen at the time of NSCLC diagnosis
结局指标
主要结局
To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
时间窗: 12 months
Treatment patterns after prescription of sequential/concurrent immunotherapy +/- platinum-based chemotherapy for non-AGA / AGA patients;
次要结局
- To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers(12 months)
- To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers(12 months)
- To assess biomarker testing patterns in advanced/metastatic NSCLC(12 months)
研究者
研究点 (1)
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