Alectinib im Vergleich zu Pemetrexed oder Docetaxel bei Patient*innen mit anaplastischer Lymphomkinase-positivem (ALK) fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC), die zuvor mit einer platinbasierten Chemotherapie und Crizotinib behandlet wurden

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

  • Krebs
  • Lungenkrebs
  • Nicht-kleinzelliges Lungenkarzinom
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Bad Berka
  • Berlin
  • Gauting
  • Immenhausen
  • Oldenburg
Studien-ID:

NCT02604342 2015-000634-29 MO29750

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      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 Studien-ID
      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

      Einschlusskriterien

      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

      Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de

       

      Über klinische Studien

      Erfahren Sie mehr über klinische Studien und wie sie durchgeführt werden

      Erfahren Sie mehr