RecruitingPhase 3NCT06128837

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)


Sponsor

Luye Pharma Group Ltd.

Enrollment

686 participants

Start Date

Mar 3, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new formulation of a chemotherapy drug called irinotecan (delivered in lipid nanoparticles as LY01610) in patients with small cell lung cancer that came back 1–6 months after their first-line chemotherapy ended. **You may be eligible if:** - You are 18 or older with confirmed small cell lung cancer - Your cancer progressed 30 days to 6 months after completing at least 4 cycles of first-line platinum-based chemotherapy - You have at least one measurable tumor - Your life expectancy is at least 3 months and your physical functioning is good (ECOG score below 2) - Your blood counts, liver, and kidney function are within required ranges **You may NOT be eligible if:** - You have compound (mixed) small cell lung cancer - Your cancer has spread to the spinal cord or brain fluid (meningeal metastasis) - You have a prior treatment with irinotecan, topotecan, or other topoisomerase I inhibitors - You have active infections, significant heart disease, or active hepatitis B, C, or HIV - You are pregnant or breastfeeding - You received anticancer therapy within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan hydrochloride liposome Injection

Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk

DRUGTopotecan

Topotecan 1.2 mg/m² intravenously Days 1-5 q3w


Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT06128837


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