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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
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
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