NCT04985201

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

Clinical Study of Irinotecan With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan intravenous infusion was administered at a dose of 60 mg/m\^2 on Day 1,8 of each 21-day cycle.
DRUG	Simvastatin	Simvastatin 40 mg daily oral tablet taken.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-01
• Completion: 2023-08-01
• First posted: 2021-08-02
• Last updated: 2021-08-09

Locations

2 sites across 1 country: China