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)

Phase 3 Completed 187 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-08-03
Primary completion: 2018-05-31
Completion: 2026-05-11

Outcome

Met primary endpoint

paper Investigator-assessed progression-free survival was significantly prolonged with alectinib versus crizotinib (hazard ratio [HR] 0·22, 95% CI 0·13-0·38; p<0·0001; PMID 30981696 ↗

release “In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib.” roche.com ↗

release “the phase III ALESIA study, showing that Alecensa® (alectinib) met its primary endpoint” roche.com ↗

Publications

Zhou C, Kim SW, Reungwetwattana T, Zhou J, Zhang Y, He J, Yang JJ, Cheng Y, Lee SH, Bu L, Xu T, Yang L, Wang C, Liu T, Morcos PN, Lu Y, Zhang L. Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study. Lancet Respir Med. 2019 May;7(5):437-446. doi: 10.1016/S2213-2600(19)30053-0. Epub 2019 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alectinib	Small molecule	600 mg	Oral
Comparator	Crizotinib	Small molecule	250 mg	Oral