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

NCT ID: NCT07231445

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-23
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1：Group A

ZG006 D1: 1 mg; D22 onward: 10 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W

Group Type: EXPERIMENTAL

ZG006

Intervention Type: DRUG

ZG006 will be administered as an IV infusion.

Serplulimab

Intervention Type: DRUG

Serplulimab will be administered as an IV infusion.

Part 1：Group B

ZG006 D1: 1 mg; D22 onward: 30 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W

Group Type: EXPERIMENTAL

ZG006

Intervention Type: DRUG

ZG006 will be administered as an IV infusion.

Serplulimab

Intervention Type: DRUG

Serplulimab will be administered as an IV infusion.

Interventions

ZG006

ZG006 will be administered as an IV infusion.

Intervention Type: DRUG

Serplulimab

Serplulimab will be administered as an IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Cong Zhang

Role: CONTACT

zhangc@zelgen.com

17602176888

Facility Contacts

Shun Lu

Role: primary

Other Identifiers

ZG006-004

Identifier Type: -

Identifier Source: org_study_id