RecruitingPhase 1NCT07231445

Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer

A Phase Ib Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

100 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • Participants with histologically or cytologically confirmed ES-SCLC.
  • 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;

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 IV infusion.

DRUGSerplulimab

Serplulimab will be administered as an IV infusion.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07231445


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