Objectives
NSCLC, toxicity
DISEASE PROGRESSION, NSCLC
The primary objective was assessment of the safety and tolerability and determination of the recommended dose of DS‐1205c in combination with gefitinib for the expansion cohort in metastatic or unresectable EGFR‐mutant NSCLC after disease progression during treatment with EGFR‐TKIs.Secondary objectives were characterization of the pharmacokinetics (PK) of DS‐1205a (free form of DS‐1205c) following DS‐1205c monotherapy, and DS‐1205a plus gefitinib combination treatment; and investigation of the antitumor activity of DS‐1205c in combination with gefitinib.Exploratory objectives were evaluation of the effect on corrected QT interval (QTc) of DS‐1205c monotherapy and in combination with gefitinib, and identification of biomarkers that correlate with efficacy or toxicity of the combination of DS‐1205c plus gefitinib.