A multicenter non-interventional cohort study to evaluate the real-world clinical management and outcomes of patients diagnosed with ALK-positive advanced NSCLC treated with alectinib - ReAlec

Roche Servicios S.A.0 个研究点开始时间: 2021年8月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.- Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study.
•2.- ALK-positive as confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor.
•3.- Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment.
•4.- Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment.
•5.- Able to be followed-up by participating site.
•6.- Participants with advanced NSCLC who have CNS metastases are eligible for inclusion.

•1.- Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information.
•2.- Participants not receiving the Roche studied medicinal product.
•3.- Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC.

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