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Sponsor: Hoffmann-La Roche
Conditions: Non-small Cell Lung Cancer
Interventions: Alectinib, Docetaxel, Pemetrexed
Countries: Belgium, Bulgaria, France, Germany, Hong Kong, Hungary, Italy, Norway
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).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Charleroi, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Sofia, Bulgaria
- Caen, France
- Paris, France
- Pessac, France
- Suresnes, France
- Toulon, France
- Toulouse, France
- Vantoux, France
- Bad Berka, Germany
- Berlin, Germany
- Gauting, Germany
- Immenhausen, Germany
- Oldenburg, Germany
- Hong Kong, Hong Kong
- Hong Kong, Hong Kong
- Budapest, Hungary
- Avellino, Campania, Italy
- Naples, Campania, Italy
- Naples, Campania, Italy
- Ravenna, Emilia-Romagna, Italy
- Rome, Lazio, Italy
- Milan, Lombardy, Italy
- Milan, Lombardy, Italy
- Catania, Sicily, Italy
- Pisa, Tuscany, Italy
- Perugia, Umbria, Italy
- Oslo, Norway
- + 24 more on CT.gov