Alectinib compared with chemotherapy in previously treated patients with ALK-positive NSCLC (ALUR)

Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

  • 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
Countries
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Korea, Republic of
  • Norway
  • Poland
  • Portugal
  • Russian Federation
  • Slovakia
  • Spain
  • Switzerland
  • Turkey
Trial Identifier:

NCT02604342 2015-000634-29 MO29750

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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

      This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02604342,MO29750,2015-000634-29 Trial Identifier
      Alectinib, Docetaxel, Pemetrexed Treatments
      Non-small Cell Lung Cancer Condition
      Official Title

      Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
      • Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
      • Prior CNS or leptomeningeal metastases allowed if asymptomatic
      • Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
      • Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
      • For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
      Exclusion Criteria
      • Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal [GI] cancer by endoscopic resection or in situ carcinoma of the cervix)
      • Participants who have received any previous ALK inhibitor other than crizotinib
      • Any GI disorder that may affect absorption of oral medications

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