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

Not Applicable

• Conditions: on-small cell lung cancer; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Anaplastic Lymphoma Kinase

• Registration Number: RPCEC00000387
• Lead Sponsor: Roche Servicios S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-05
• Last Update Posted: 19 August 2024
• Study Completion: 2025-07-31
• Results First Posted: 2025-08-14

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified