RecruitingPhase 3NCT06612151

A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects with Relapsed Small Cell Lung Cancer


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

438 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study tests a new drug called YL201 in people with small cell lung cancer (SCLC) that has come back or stopped responding to prior treatments. SCLC is an aggressive form of lung cancer, and new treatment options are urgently needed for patients whose disease has relapsed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with small cell lung cancer (SCLC) confirmed by biopsy - Your cancer has come back after prior treatment - You are in good physical health (ECOG performance status 0 or 1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have untreated or active spread of cancer to the brain or spinal cord - You have had serious immune-related side effects from prior immunotherapy - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGYL201

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle at RP3D dose level.

DRUGtopotecan hydrochloride for injection

Topotecan hydrochloride will be administered intravenously per prescribing information.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06612151


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