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)

Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer Clinical Trial

Official title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Lymphoma

• NCT number: NCT02838420
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 3, 2016
• Completion date: March 31, 2026