An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib (ReAlec)

Roche

Status: Active, not recruiting

Conditions: NSCLC

Treatments: Drug: Alectinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04764188

MO42122

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Trial design

800 participants in 2 patient groups

Cohort 1

Description:

Participants starting alectinib treatment after (Arm A) or before (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years.

Treatment:

Drug: Alectinib

Cohort 2

Description:

Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.

Treatment:

Drug: Alectinib