Irinotecan liposome combined with anlotinib as second-line treatment in patients with small cell lung cancer (SCLC).

e20105 Background: Irinotecan is one of the options for the second-line treatment of SCLC. Liposomal irinotecan can specifically target tumor areas due to its enhanced permeability and retention (EPR) effect, which may reduce toxicity and improve efficacy. Anlotinib is approved for the treatment of patients with SCLC who have progressed or relapsed after at least two previous chemotherapy regimens. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with anlotinib for patients with relapsed SCLC. Methods: This is a single-arm, multi-center study. Patients who progressed on or within six months after platinum-based first-line therapy received irinotecan liposome (70 mg/m² intravenously on Day 1 of every 14-day cycle) and anlotinib (12 mg/day for two consecutive weeks, followed by a one-week discontinuation). Treatment continued until disease progression or intolerable toxicity. The primary endpoint was the objective response rate (ORR), while secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Results: From April 2024 to November 2024, 11 patients were enrolled in this study, all were male, with ages ranging from 59 to 71 years (median: 66 years). Ninety-one percent of the participants had an ECOG performance status of 1. Additionally, 27.3% presented with brain metastases, 54.5% had liver metastases, and 63.6% had bone metastases. Six patients underwent at least one tumor assessment; among them, 4 patients achieved partial response, 1 patient exhibited stable disease, and 1 patient had progressive disease. The ORR was 66.7% and the DCR was 83.3%. As of January 7, 2024, 9 patients discontinued treatment due to disease progression (n=4), treatment delays exceeded the time specified in the protocol (n=3), withdrawal of informed consent (n=2), and death (n=1). Treatment-related adverse events (TRAEs) and grade ≥3 TRAEs were reported in 10 patients (90.9%) and 8 patients (72.7%), respectively. The most common grade ≥3 TRAEs (≥10%) included diarrhea (2/11, 18.2%) and leukopenia (2/11, 18.2%). Conclusions: The combination of irinotecan liposome and anlotinib demonstrated the anticipated efficacy and safety in patients with platinum-resistant SCLC, warranting further investigation. Clinical trial information: NCT06258642 .