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RecruitingPhase 3NCT07189455

Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

420 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer

Summary

The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called ZG006 against standard chemotherapy options for people with small cell lung cancer (SCLC) that has come back after prior treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with small cell lung cancer (confirmed by biopsy or lab test) - You are well enough to participate (ECOG score 0 or 1) - Your expected survival is at least 3 months - You have read and signed the informed consent form **You may NOT be eligible if...** - Your doctor has determined you are not suitable for the study for any medical reason 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

DRUGZG006

ZG006 will be administered as an intravenous (IV) infusion.

DRUGTopotecan

Topotecan will be administered per local standard of care

Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07189455

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