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)

NCT06128837 Phase 3 RECRUITING

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)

Details

Lead sponsor	Luye Pharma Group Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	686
Start date	2024-03-03
Completion	2028-10

Conditions

• Relapsed Small Cell Lung Cancer

Interventions

• Irinotecan hydrochloride liposome Injection
• Topotecan

Primary outcomes

• Overall survival (OS) — From the date of randomization to the date of death or last contact, whichever occurs first, assessed up to 52 month
  Overall survival is defined as the time from randomization to date of death.

Countries

China