CTRI/2024/03/063721进行中（未招募）不适用
Non-Interventional Study - Use of lorlatinib in treatment-naïve adult patients with metastatic or locally advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) from India.
Pfizer Products India Private Limited9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Progression Free Survival (PFS) rate, Time Points- 18 months
研究概览
简要总结
The proposed study is multicenter, ambispective (retrospective and prospective) non-interventional, real-world study will be designed to gather and analyze safety and effectiveness data from treatment-naïve metastatic or locally advanced ALK-positive NSCLC patients with or without brain metastases.
The objective is to record safety and effectiveness of lorlatinib as 1L treatment for treatment naïve metastatic or locally advanced ALK-positive NSCLC patients with or without brain metastases under the setting of routine clinical practice in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (Stage IV) NSCLC with positive ALK-rearrangement No prior systemic treatment for metastatic disease, however up to 2 cycles of chemotherapy are permitted.
排除标准
- •Patients who fail to meet the predefined criteria for inclusion will be excluded from the study.
结局指标
主要结局
Progression Free Survival (PFS) rate, Time Points- 18 months
时间窗: 18-months
次要结局
- Estimation of overall survival (OS), PFS, objective response rate (ORR), intra-cranial ORR (IC-ORR), duration of response (DR, overall and intracranial duration of response), intracranial time to progression (for patients with and without brain metastases at diagnosis), Time to symptomatic response, PFS 2, Subsequent treatment and duration(Safety (Including rates of dose interruption/dose reduction and treatment discontinuation), Frequency and nature of all-causality adverse events (AEs))
研究者
研究点 (9)
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