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Completed NCT02838420

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions: Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 187
Sponsor: Hoffmann-La Roche

Location: Beijing Cancer Hospital Beijing

Summary

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 2:1 into one of the two treatment groups to receive either alectinib (600 milligrams \[mg\] twice daily \[BID\]) or crizotinib (250 mg BID) orally, respectively.

Eligibility 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 immunohistochemistry (IHC) test. Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 * No history of receiving systemic treatment for advanced, recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC * Adequate hematologic function: Platelet count greater than equal to (\>=) 100×10\^9 per liter (/L); absolute neutrophil count (ANC) \>=1500 cells per microliter (cells/mcL); hemoglobin\>=9.0 grams per deciliter (g/dL) * Adequate renal function: an estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula of \>=45 milliliters per minute per 1.73 square meter * Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before receiving the first dose of study treatment * Measurable disease (by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) before administration of study treatment * Previous brain or leptomeningeal metastases are allowed if the participant is asymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic central nervous system (CNS) lesions may be treated at the discretion of the investigator as per local clinical practice. If participant has neurological symptoms or signs because of CNS metastasis, the participant must complete whole-brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed \>=14 days before enrollment and disease must be clinically stable * For all females of childbearing potential, a negative serum pregnancy test result must be obtained within 3 days prior to 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), agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02838420). StuddyBuddy aggregates publicly available trial information.