{"groups":[{"description":"Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"FG000","title":"Lorlatinib"},{"description":"Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"FG001","title":"Crizotinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"12"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Global Deterioration of Health Status"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Subject decided to continue study treatment as per clinical practice in another hospital."},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Subject didn't receive study treatment."},{"reasons":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"31"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"149"},{"groupId":"FG001","numSubjects":"147"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"83"}],"comment":"\"Completed\" refers to participants with confirmed RECIST version 1.1 defined disease progression assessed by the blinded independent central review or investigator.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"64"}],"type":"NOT COMPLETED"}],"title":"Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"28"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"18"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"99"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"149"},{"groupId":"FG001","numSubjects":"147"}],"comment":"The long-term follow-up phase included the post-treatment follow-up and the survival follow-up. Participants who started the long-term follow-up phase consisted of participants in both the post-treatment follow-up and the survival follow-up.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"149"},{"groupId":"FG001","numSubjects":"147"}],"type":"NOT COMPLETED"}],"title":"Long-Term Follow-up Phase"}],"preAssignmentDetails":"Previously untreated Stage IIIB/IV participants with ALK-positive non-small cell lung cancer were randomized in this study.","recruitmentDetails":"This phase 3, randomized, open label study was conducted at 104 sites in 23 countries. A total of 296 participants were randomized, 149 to the lorlatinib arm and 147 to the crizotinib arm."}