clinical trial · 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)
Hoffmann-La Roche·phase3·active not recruiting·n = 187
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung CancerAlectinibCrizotinib
brief 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.
started
Aug 3, 2016
primary completion
May 31, 2018
completion
Jun 30, 2026
last updated
Mar 18, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol