Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea

  • 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:

Completed

This trial runs in
Country
  • South Korea
Trial Identifier:

NCT03271554 ML30132

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      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

      Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT03271554, ML30132 Trial Identifier
      Alectinib Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥ 19 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.
      Exclusion Criteria
      • Hypersensitivity to alectinib or any ingredient of alectinib;
      • Pregnant or lactating women;
      • Pediatric subjects (age </=18 years);
      • Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.

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

       

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