NCT04727853

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)

A Multicenter, Open-label, Single-arm Phase 2 Study of Irinotecan Liposome Injection in Patients With Small Cell Lung Cancer (SCLC) Who Have Progressed After Platinum-based First-line Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity.

Detailed description

Patients with small cell lung cancer who have progressed after platinum-based first-line therapy will be enrolled in this study. Patients will receive irinotecan liposome injection at 70 mg/m\^2 intravenously, over 90 min on Days 1 of every 14-day cycle until progression or unacceptable toxicity. Imaging assessments will be conducted every three cycles to evaluate the preliminary efficacy of irinotecan liposome injection as second-line regimen in patients with SCLC.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	irinotecan liposome injection	Drug: irinotecan liposome injection

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2021-01-27
• Last updated: 2024-07-10

Locations

1 site across 1 country: China