Estudio de cohorte no intervencional multicéntrico para evaluar el manejo clínico en la práctica real y los resultados de pacientes con CPNM avanzado ALK-positivo tratados con alectinib (ReAlec)

Activo, no reclutaClinicalTrials.gov

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

Resumen

Este estudio tiene como objetivo caracterizar el manejo clínico en la práctica real y los resultados de los participantes diagnosticados con cáncer de pulmón de células no pequeñas (CPNM) avanzado positivo para la cinasa del linfoma anaplásico (ALK) que están siendo tratados con alectinib.

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

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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