RANDOMIZED, MULTICENTER, PHASE III,OPEN-LABEL STUDY OF ALECTINIB VERSUSCRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTICLYMPHOMA KINASE−POSITIVE ADVANCEDNON−SMALL CELL LUNG CANCER

F. HOFFMANN-LA ROCHE LTD.,0 sites0 target enrollmentMarch 20, 2015

Overview

No summary available.

Registry

who.int

Start Date

March 20, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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
•as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK
•FISH is required. Both tests will be performed at designated central laboratories.
•Age ≥ 18 years old.
•Life expectancy of at least 12 weeks.
•ECOG PS of 0\-2\.
•Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not
•amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
•Adequate hematologic function:

•Patients 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, in situ carcinoma of the cervix, or any cured cancer that is considered
•to have no impact in PFS and OS for the current NSCLC).
•Any GI disorder that may affect absorption of oral medications, such as mal\-absorption
•syndrome or status post\-major bowel resection.
•Liver disease characterized by:
•ALT or AST \> 3 × ULN (≥ 5 × ULN for patients with concurrent liver metastasis)
•confirmed on two consecutive measurements
•Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other