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) (ReAlec)

  • End date
    Apr 9, 2027
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 23 October 2022
lung carcinoma


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.

Condition NSCLC
Treatment Alectinib
Clinical Study IdentifierNCT04764188
SponsorHoffmann-La Roche
Last Modified on23 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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