eXalt3: Phase 3 randomized study comparing ensartinib to crizotinib in anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients
Invited conference paper presented and published in conference proceedings



摘要Background: Ensartinib (X-396) is a novel, potent ALK small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naïve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of ensartinib appears to be different than other ALK TKIs. Methods: In this global, phase 3, open-label, randomized study, approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized with stratification by prior chemotherapy (0/1), performance status (0-1/2), brain metastases at screening (absence/presence), and geographic region (Asia /other), to receive oral ensartinib (225 mg, once daily) or crizotinib (250mg, twice daily) until disease progression or intolerable toxicity. Eligibility also includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The primary endpoint is progression-free survival assessed by independent radiology review based on RECIST v. 1.1 criteria. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. The study has > 80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05. Phase 3 recruitment began in June, 2016 and currently has 98 active sites in 20 countries. The duration of recruitment will be approximately 24 months. This study is registered with. Clinical trial information: NCT02767804
著者Leora Horn, Yi-Long Wu, Martin Reck, Heather A. Wakelee, Chris Liang, Fenlai Tan, Kimberly Harrow, Vance Oertel, Gary Dukart, Tony Mok
會議名稱ASCO Annual Meeting 2018
會議地點Chicago, IL
會議論文集題名Journal of Clinical Oncology
系列標題Lung Cancer—Non-Small Cell Metastatic
叢書冊次Poster Session (Board #432b); suppl; abstr TPS9115
期次15 suppl

上次更新時間 2020-15-08 於 02:14