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

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Drug: Serplulimab; Drug: ZG006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231445

ZG006-004

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Part 1：Group A

Experimental group

Description:

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

Treatment:

Drug: ZG006

Drug: Serplulimab

Part 1：Group B

Experimental group

Description:

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

Treatment:

Drug: ZG006

Drug: Serplulimab