Doxitinib mesylate

Phase I Primary Objectives: To evaluate the safety and tolerability of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy, and to determine the RP2D. Secondary Objectives: To evaluate the efficacy of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy; To evaluate the pharmacokinetic profile of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy. Exploratory Objectives: To investigate the association between tumor microenvironment and efficacy; To investigate the association between gene mutations in plasma circulating tumor DNA (ctDNA) and/or tumor tissue and efficacy (only patients who have progressed after prior treatment with third-generation EGFR-TKIs). Phase IIa Primary Objectives: To evaluate the efficacy and safety of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Secondary objectives: Evaluate the pharmacokinetic profile of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Exploratory objectives: To investigate the association between the tumor microenvironment and efficacy; To investigate the association between gene mutations in plasma cell-free ctDNA and/or tumor tissue and efficacy (limited to patients whose disease has progressed after prior treatment with third-generation EGFR-TKIs).