{"entity":{"id":"j-alex","kind":"trial","name":"J-ALEX","aka":[],"tldr":"The Japanese trial that beat crizotinib with alectinib first, at half the dose used everywhere else, and was stopped early because the difference was so large.","summary":"J-ALEX recruited 207 ALK inhibitor-naive Japanese patients at 41 sites between November 2013 and August 2015 and randomised them 1:1 to alectinib 300 mg twice daily (103) or crizotinib 250 mg twice daily (104), stratified by performance status, treatment line and disease stage. The alectinib dose is half the 600 mg twice daily used in ALEX and ALESIA, because Japanese pharmacokinetic work had settled on it.\n\nAt the second interim analysis (data cutoff 3 December 2015) the independent data monitoring committee stopped the trial: 24 patients had discontinued alectinib against 61 on crizotinib, mostly for lack of efficacy or adverse events, and independently reviewed progression-free survival strongly favoured alectinib.\n\nJ-ALEX reported before ALEX and is the reason Japan approved alectinib first line at 300 mg twice daily while the rest of the world uses 600 mg. The two doses have never been compared head to head, and whether the higher one is necessary is still open.","status":"positive","asOf":"2026-09-25","links":[{"label":"J-ALEX (Lancet 2017)","url":"https://doi.org/10.1016/S0140-6736(17)30565-2"},{"label":"Japan Pharmaceutical Information Center JapicCTI-132316","url":"https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-132316"}],"tags":[],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib","crizotinib"],"companies":["chugai"],"institutions":[],"pathways":[],"terms":["tki-term","brain-metastases"],"trials":["alex","alesia","profile-1014"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"ALK inhibitor-naive Japanese patients with ALK-positive non-small-cell lung cancer, chemotherapy-naive or after one regimen: alectinib 300 mg twice daily versus crizotinib 250 mg twice daily, with progression-free survival by an independent review facility as the primary endpoint","sponsor":"Chugai Pharmaceutical","result":"Stopped at the second interim analysis for a large progression-free survival advantage of alectinib over crizotinib.","yearReported":2017,"enrolled":207,"enrolledBasis":"randomised","enrolledNote":"207 patients were recruited at 41 Japanese sites; the trial is registered with the Japan Pharmaceutical Information Center as JapicCTI-132316 and has no ClinicalTrials.gov record, so there is no registry figure.","outcomes":[],"replication":"ALEX reproduced the result globally at 600 mg twice daily, and ALESIA reproduced it in Chinese, Korean and Thai patients at the same 600 mg dose."},"route":"/trials/j-alex/","neighbours":{"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"drug":[{"id":"alectinib","kind":"drug","name":"Alectinib","route":"/drugs/alectinib/"},{"id":"crizotinib","kind":"drug","name":"Crizotinib","route":"/drugs/crizotinib/"}],"company":[{"id":"chugai","kind":"company","name":"Chugai Pharmaceutical","route":"/companies/chugai/"}],"term":[{"id":"brain-metastases","kind":"term","name":"Brain metastases (intracranial disease)","route":"/terms/brain-metastases/"},{"id":"tki-term","kind":"term","name":"Tyrosine kinase inhibitor (TKI)","route":"/terms/tki-term/"}],"trial":[{"id":"alesia","kind":"trial","name":"ALESIA","route":"/trials/alesia/"},{"id":"alex","kind":"trial","name":"ALEX","route":"/trials/alex/"},{"id":"profile-1014","kind":"trial","name":"PROFILE 1014","route":"/trials/profile-1014/"}]}}