NCT06467786

Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.

Detailed description

Based on literature research and the birth of independently developed irinotecan liposomes by Shiyao, we plan to conduct a therapeutic study on the combination of irinotecan liposomes and cisplatin/carboplatin for platinum sensitive recurrent small cell lung cancer. The aim is to explore the efficacy and safety of the combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line treatment of small cell lung cancer patients who have progressed after 6 months using platinum based regimens, providing better clinical evidence for use. The research unit is the Second Affiliated Hospital of Air Force Military Medical University. The study includes screening period (within 28 days), treatment period, and follow-up period (safety follow-up and PFS follow-up). The subjects signed an informed consent form and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety, tolerance, and efficacy. The same subject only received one dosing plan during the study period. After the treatment period ends, enter the follow-up period.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan hydrochloride liposome injection	Irinotecan hydrochloride liposome injection combined with platinum

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-09-15
• Completion: 2028-09-15
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: China