YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Timeframe: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.
Objective Response Rate (ORR)
Timeframe: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.