{"groups":[{"description":"Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.","id":"FG000","title":"Arm A: Treatment Period- SOC"},{"description":"Participants received pralsetinib, 400 milligrams (mg), orally, once a day (QD) on Day 1 of each cycle until PD, post-trial access program (PTAP), pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).","id":"FG001","title":"Arm B: Treatment Period- Pralsetinib"},{"description":"Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).","id":"FG002","title":"Arm C: Crossover Period- Pralsetinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"0"}],"type":"Informed Consent Withdrawn"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Reason Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"0"}],"type":"Study Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"110"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"108"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Safety-evaluable population included all participants who received any amount of any study drug.","type":"Safety-evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"110"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"8"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Informed Consent Withdrawn"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"Reason Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"21"}],"type":"Study Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"38"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"38"}],"type":"NOT COMPLETED"}],"title":"Crossover Period"}],"preAssignmentDetails":"Participants in treatment period were randomized in 1:1 ratio to receive standard of care (SOC) platinum containing anticancer treatment regimens (Arm A) or pralsetinib (Arm B). Participants with disease progression (PD) in Arm A had the option to crossover \\& receive pralsetinib (Arm C), which was later discontinued as of Protocol Version 5. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.","recruitmentDetails":"A total of 223 participants with rearranged during transfection (RET) fusion-positive metastatic non-small cell lung cancer (NSCLC) took part in the study at 74 investigative sites across 22 countries from 24 July 2020 to 27 January 2025. The study consists of a treatment period and a crossover period."}