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

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

Inclusion Criteria5

  • Fully understand the study and voluntarily sign the informed consent form;
  • Male or female 18~75 years of age;
  • Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 3 months;
  • Histologically or cytologically confirmed Small Cell Lung Cancer.

Exclusion Criteria1

  • Participants were deemed unsuitable for participating in the study by the investigator for any reason.

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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