NCT06128837

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 686 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)

Detailed description

A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.

Conditions

• Relapsed Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan hydrochloride liposome Injection	Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk
DRUG	Topotecan	Topotecan 1.2 mg/m² intravenously Days 1-5 q3w

Timeline

• Start date: 2024-03-03
• Primary completion: 2028-06-01
• Completion: 2028-10-01
• First posted: 2023-11-13
• Last updated: 2024-03-15

Locations

1 site across 1 country: China