| Description |
Male and female patients aged 18 years and over with locally advanced or metastatic pathologically confirmed adenocarcinoma of the lung, with tumour that harbours one of the most common EGFR mutations known to be associated with EGFR-TKI sensitivity (exon 19 deletion; L858R) either alone or in combination with other EGFR mutations as confirmed by a local test. This Study includes 2 parts. Part A:To investigate the safety and tolerability of Osimertinib combined with Anlotinib hen given orally as first line therapy to patients who are treatment-naive for locally advanced or metastatic EGFRm+ NSCLC. Part B: To observe the efficacy of RP2D, including ORR, DOR, DCR, PFS, overall survival at 12 months of Osimertinib combined with Anlotinib when given orally as first line therapy to patients who are treatment-naive for locally advanced or metastatic EGFRm+ NSCLC. To further investigate the safety and tolerability of Osimertinib combined with Anlotinib when given orally as first line therapy to patients who are treatment-naive for locally advanced or metastatic EGFRm+ NSCLC. |
