Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

Overview

This Phase II study was designed to evaluate the safety and efficacy of irinotecan in combination with simvastatin compared with treatment with irinotecan alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either irinotecan (4 cycles) + simvastatin (10 months) or irinotecan (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

PRIMARY OBJECTIVES: I.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with irinotecan + simvastatin or with irinotecan alone. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To assess disease control rate (DCR) after treatment. III.To estimate overall survival (OS) of patients with ES-SCLC. IV. To evaluate the toxicity profile of irinotecan + simvastatin. EXPLORATORY OBJECTIVES: I.To evaluate biomarkers correlatives. II.To explore the mechanism of irinotecan + simvastatin in the treatment of chemotherapy-resistant participants with ES-SCLC. OUTLINE: Patients are divided into two arms. ARM A: Participants received intravenous infusions of irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles) in combination with oral simvastatin (40mg daily) （10 months）until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor. ARM B:Participants received intravenous infusions of irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles) until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.