{"groups":[{"description":"Brigatinib 90 mg, tablets, orally, once daily (QD) for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until disease progression (PD), intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).","id":"FG000","title":"Randomized Phase: Brigatinib 90 mg QD/180 QD"},{"description":"Crizotinib 250 mg, tablets, twice daily (BID) in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).","id":"FG001","title":"Randomized Phase: Crizotinib 250 mg BID"},{"description":"Participants who experienced PD as assessed by the blinded Independent Review Committee (BIRC) or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).","id":"FG002","title":"Crossover Phase: Brigatinib 90 mg QD/180 mg QD"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"0"}],"type":"Died"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"0"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Reason not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Never Treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"138"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"136"},{"groupId":"FG001","numSubjects":"137"},{"groupId":"FG002","numSubjects":"0"}],"type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"54"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomized Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"22"}],"type":"Died"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrew Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"23"}],"type":"Site Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"65"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"55"}],"type":"NOT COMPLETED"}],"title":"Crossover Phase"}],"preAssignmentDetails":"Participants with anaplastic lymphoma kinase and non-small-cell lung cancer (ALK+ NSCLC) who had not previously received an ALK-targeted tyrosine kinase inhibitor (TKI) were enrolled in 1:1 ratio to receive brigatinib 90 mg for 7 days followed by 180 mg or crizotinib 250 mg. Participants from crizotinib arm who experienced progressive disease (PD) or received radiotherapy to the brain in Randomized Phase were crossed over to receive brigatinib 90 mg/180 mg in the Crossover Phase.","recruitmentDetails":"Participants took part in the study at 92 investigative sites in Australia, Hong Kong, Singapore, South Korea, Taiwan, Austria, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Canada, and the United States of America from 26 May 2016 to 29 January 2021."}