22P Adding anlotinib in gradual or local progression on first-line EGFR-TKIs for advanced non-small cell lung cancer: A single-arm, multicenter, phase II trial

Anlotinib plus EGFR-TKIs continuation was a potential treatment strategy in selected advanced non-small cell lung cancer (NSCLC) after disease progression first-line EGFR-TKIs. This study aimed to evaluate the efficacy and safety of combined anlotinib. The trial enroll 120 patients gradual or local treatment. All were treated with oral anlotinib 12 mg daily for 14 days every three weeks until intolerable toxicity. primary end-point progression-free survival (PFS). secondary end-points 6 months PFS rate, Overall response rate (ORR), control (DCR), overall (OS) safety. From July 08, 2019 December 15, 2022 enrollment completed, including 109 progression. Up 31, 2022, 114 available assessment (105 had confirmed evaluation). Median 9.2 (95% CI, 6.6–11.6). Confirmed ORR 5.7% DCR 92.4%. at 66.3% 36.7% respectively. Safety 116 patients, 94% (109/116) reported related adverse events (TRAEs). incidence grade 3 4 TRAEs 36.2% (42/116) treatment-related serious event (SAE) 7.8% (9/116). common diarrhea (47.4%), hypertension (42.2%), proteinuria (39.7%), hypertrigly-ceridemia (24.1%). 22.4% (26/116) experienced dose reduction. demonstrated meaningful clinical NSCLC And toxicity clinically manageable.