Status:
ACTIVE_NOT_RECRUITING
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
Lead Sponsor:
Hoffmann-La Roche
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 10 2027
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04764188
Start Date
May 10 2021
End Date
May 10 2027
Last Update
October 16 2025
Active Locations (116)
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1
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
2
Lifehouse
Camperdown, New South Wales, Australia, 2050
3
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
4
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065000