NCT06644495尚未招募不适用
Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- The incidence of adverse drug reactions in the overall population
研究概览
简要总结
The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with Iruplinalkib or planned to receive Iruplinalkib treatment in real-world clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Pathologically confirmed patients with locally-advanced or metastatic ALK-positive non-small cell lung cancer.
- •Currently receiving, or planned to receive treatment with Iruplinalkib.
- •Subjects had imaging reports of chest and abdominal enhanced CT and brain MRI within 42 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.
- •Subjects had routine and biochemical reports within 30 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.
排除标准
- •Patients who had previously been treated with ALK-TKI, but who had previously only been treated with ALK-TKI as neoadjuvant and/or adjunctive treatment could be enrolled.
- •Mental disorder or inability to cooperate with examination or follow-up.
- •Women known to be pregnant or lactating.
结局指标
主要结局
The incidence of adverse drug reactions in the overall population
时间窗: At enrollment and every 3 months thereafter (up to 3 years)
次要结局
- The incidence of greater than or equal to grade 3 AEs, SAEs, AEs resulting in dose reduction/interruption/discontinuation, AESIs, and AEs resulting in death in the overall population(At enrollment and every 3 months thereafter (up to 3 years))
- Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib(From the first administration of Iruplinalkib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 3 years).)
- Time to treatment failure (TTF) for 1L treatment with Iruplinalkib(From the first administration of Iruplinalkib to the date of first documentation of discontinuation of Iruplinalkib due to any cause (up to 3 years).)
- Event to first follow-up treatment or death (TFST) for 1L treatment with Iruplinalkib(From the first administration of Iruplinalkib to the date of first documentation of initiation of next line of treatment, or death due to any cause, whichever occurs first (up to 3 years).)
研究者
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