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

  • Non-Small Cell Lung Cancer
Trial Status:


This trial runs in
  • Abu Dhabi
  • Ankara
  • Barnaul
  • Bedford Park
  • Beograd
  • Bogotá
  • Camperdown
  • chang-sha-shi
  • Chelyabinsk
  • Gent
  • guang-zhou-shi
  • Haifa
  • hang-zhou-shi
  • Havana
  • he-fei-shi
  • İstanbul
  • Jinan
  • Kaunas
  • Klagenfurt am Wörthersee
  • Krasnoyarsk
  • La Habana
  • Liverpool
  • Lombardy
  • Lucca
  • Montevideo
  • nan-jing-shi
  • nan-ning-shi
  • Niš
  • Padua
  • Palermo
  • Panamá
  • Perugia
  • Petah Tikva
  • Porto
  • Ramat Gan
  • Reggio Calabria
  • Roma
  • Rome
  • Saint Petersburg
  • Sremska Kamenica
  • tai-zhou-shi
  • Taiyuan
  • Tampere
  • Taranto
  • Tel Aviv-Yafo
  • tian-jin-shi
  • Turku
  • Tuscany
  • Ufa
  • Vila Nova de Gaia
  • Vilnius
  • Wien
  • Wuhan
  • Xuzhou
  • دبي
Trial Identifier:

NCT04764188 MO42122

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      The source of the below information is the publicly available website It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website within a week of any updates, and has not been edited.

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      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
      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

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