A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

简要总结

详细描述

主要结局

次要结局

• Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1(At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months)
• Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death(At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months)
• Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first(At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months)
• Overall survival (OS), defined as the time from first administration of study drug until death from any cause(From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months)
• Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1(At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months)
• Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response(At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months)
• Peak concentration (Cmax) of HM61713(Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22))
• Trough plasma concentration (Ctrough) of HM61713(Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22))
• Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713(Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22))
• Patient reported outcomes (PROs)(At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months)
• ECG/QTc (absolute values and change from baseline)(Adverse events will be collected from baseline until 28 days after the last dose)
• QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.(Adverse events will be collected from baseline until 28 days after the last dose)
• Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).(Adverse events will be collected from baseline until 28 days after the last dose)