{"entity":{"id":"alesia","kind":"trial","name":"ALESIA","aka":[],"tldr":"Repeated the ALEX trial in Chinese, Korean and Thai patients at the Western dose, and found the same answer.","summary":"ALEX had established alectinib as the first-line ALK inhibitor, but it used 600 mg twice daily, whereas Japan had approved 300 mg twice daily, and there was a question about whether the Western dose and the Western result transferred to Asian populations. ALESIA randomised 187 Asian patients at 21 sites in China, South Korea and Thailand 2:1 to alectinib 600 mg twice daily (125 patients) or crizotinib 250 mg twice daily (62), stratified by performance status and baseline central nervous system metastases, with asymptomatic brain metastases permitted.\n\nAt a median follow-up of 16.2 months on alectinib and 15.0 on crizotinib, investigator-assessed progression-free survival was significantly longer with alectinib, consistent with the global ALEX result.\n\nALESIA is the reason the 600 mg dose is used across Asia outside Japan, and it is one of the cleanest demonstrations that an ALK result travels between populations, which is not true of every lung cancer finding.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02838420","url":"https://clinicaltrials.gov/study/NCT02838420"},{"label":"ALESIA (Lancet Respiratory Medicine 2019)","url":"https://doi.org/10.1016/S2213-2600(19)30053-0"}],"tags":[],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib","crizotinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["brain-metastases","tki-term"],"trials":["alex","profile-1014"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02838420","phase":"3","setting":"Untreated ALK-positive non-small-cell lung cancer in Asian patients: alectinib 600 mg twice daily versus crizotinib 250 mg twice daily, with investigator-assessed progression-free survival as the primary endpoint","sponsor":"Roche","result":"Investigator-assessed progression-free survival significantly longer with alectinib than crizotinib, consistent with the global ALEX trial.","yearReported":2019,"enrolled":187,"enrolledBasis":"registry","outcomes":[],"replication":"Consistent with the global ALEX trial and with the Japanese J-ALEX trial at the lower dose."},"route":"/trials/alesia/","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":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"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":"alex","kind":"trial","name":"ALEX","route":"/trials/alex/"},{"id":"j-alex","kind":"trial","name":"J-ALEX","route":"/trials/j-alex/"},{"id":"profile-1014","kind":"trial","name":"PROFILE 1014","route":"/trials/profile-1014/"}]}}