This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.
This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-nave and eligible for first-line treatment with an EGFR-TKI.
|Treatment||Gefitinib 250 mg, Lazertinib 240 mg/160 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg|
|Clinical Study Identifier||NCT04248829|
|Last Modified on||11 November 2020|
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