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

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Chile
  • China
  • Colombia
  • Croatia
  • Cuba
  • Czechia
  • Finland
  • Israel
  • Italy
  • Lithuania
  • Peru
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Türkiye
  • United Arab Emirates
  • Uruguay
  • Vietnam
Trial Identifier:

NCT04764188 MO42122

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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 treated with alectinib in real-world clinical practice.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT04764188, MO42122 Trial Identifier
      Alectinib Treatments
      NSCLC Condition
      Official Title

      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)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

      Related Trials

      Use our search to find other trials on ForPatients in related disease areas.

      Non-Small Cell Lung Cancer (NSCLC)

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now