EXALT3: Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer 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). It is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naı¨ve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of
ensartinib appears to be different from other ALK TKIs. Trial design: In this global, phase 3, open-label, randomized study, approximately 270 patients with ALKþ 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 ALKþ 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 21 countries. The duration of recruitment will be approximately 28 months. Clinical trial identification: NCT02767804.
著者L. Horn, Y. Wu, M. Reck, H. Wakelee, C. Liang, K. Harrow, V. Oertel, T. Mok
會議名稱ESMO 2018 Congress
會議論文集題名Annals of Oncology
系列標題Poster Display
叢書冊次Abst: 1500TiP
期次Suppl 8

上次更新時間 2020-13-08 於 00:56