None listed
Conditions
Interventions
The experimental arm will receive alectinib at 600 mg orally twice daily (BID), taken with food.
The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
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 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: Platelet count ≥ 100 × 109/L ANC ≥ 1500 cells/μL Hemoglobin ≥ 9.0 g/dL • Adequate renal function: Calculated creatinine clearance at least 45 mL/min • Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment. • Measurable disease (by RECIST v1.1) prior to the administration of study treatment. • Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable. • For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment. • For women who are not postmenopausal ( ≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus).
Exclusion criteria
Exclusion criteria: 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 OR Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices OR Acute viral or active autoimmune, alcoholic, or other types of hepatitis • National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication. • History of organ transplant. • Co-administration of anti-cancer therapies other than those administered in this study. • Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia < 45 beats per minute. • Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib or crizotinib except for oral corticosteroids up to 20 mg of prednisolone equivalent per day • Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug and while on treatment. • History of hypersensitivity to any of the additives in the alectinib drug formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulfate [SLS], magnesium stearate). • History of hypersensitivity to any of the additives in the crizotinib drug formulation (silica, colloidal anhydrous cellulose, microcrystalline calcium hydrogen phosphate, anhydrous sodium starch glycolate, magnesium stearate). • Pregnant or lactating women. • Known HIV positivity or AIDS-related illness.
Countries
Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea North, Macedonia, New Zealand, Panama, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed