Efficacy and safety of albumin-bound paclitaxel combined with simvastatin in the second-line treatment of small cell lung cancer: a phase II randomized controlled trial

BACKGROUND: Small-cell lung cancer (SCLC) responds to first-line therapy, but most patients rapidly develop resistance. This study aimed to investigate the efficacy and safety of nab-paclitaxel combined with simvastatin as second-line treatment for SCLC patients. METHODS: In this phase II randomized trial, patients received nab-paclitaxel alone or in combination with simvastatin. The primary endpoint was disease control rate (DCR); secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: DCR was higher for the nab-paclitaxel plus simvastatin group than in the nab-paclitaxel group (92.9% vs. 44.4%, P = 0.005). ORR (50.0% vs. 11.1%, P = 0.017) and median PFS (113 vs. 62 days; HR = 0.42, 95% CI = 0.19-0.92; P = 0.029) were also improved. No significant difference in OS was observed. Treatment-related toxicities were manageable in both groups. CONCLUSIONS: In this phase II randomized study, nab-paclitaxel plus simvastatin was associated with improved DCR, ORR, and PFS, with manageable toxicity, as second-line treatment for patients with small-cell lung cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT04698941.