NCT06258642

Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC

Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.

Detailed description

Patients will receive irinotecan liposome injection at 70 mg/m\^2 intravenously, on Days 1 of every 14-day cycle and anlotinib (12 mg/day) for 2 consecutive weeks and then discontinued for 1 week. The treatment is continued until disease progression or intolerable toxicity.

Conditions

• Small Cell Lung Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome	70 mg/m\^2 , d1, Q2W, iv
DRUG	Anlotinib	12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week.

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2024-02-14
• Last updated: 2025-08-20

Locations

1 site across 1 country: China