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)

Activo, no reclutaClinicalTrials.gov

ID: NCT04764188Tipo: OBSERVATIONALInicio: 10 de may de 2021Fin estimado: 10 de may de 2027

Traducción no disponible, mostrando original

Resumen

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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
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
Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment
Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment
Able to be followed-up by participating site
Participants with advanced NSCLC who have CNS metastases are eligible for inclusion

Criterios de exclusión

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

Intervenciones

drug

Alectinib

Participants will receive alectinib in accordance with local clinical practice and local labeling.

Ubicaciones

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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