"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate".
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Percentage of patients with available NGS testing at diagnosis
研究概览
简要总结
The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.
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
- •a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available)
- •b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days
- •c) ECOG PS 0-2
- •d) adult patients (aged ≥ 18 years) at the moment of diagnosis
- •e) signing of informed consent approved by the local Ethic Committee
排除标准
- •a) Diagnosis of lung cancer without ALK rearrangement
- •a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study
结局指标
主要结局
Percentage of patients with available NGS testing at diagnosis
时间窗: 5 years
Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy
Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor
时间窗: 5 years
Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy
次要结局
- PFS to first-line treatment with II-III generation ALK-inhibitor(5 years)
研究者
Bria Emilio
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS