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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07231445

Enrollment

100

Registered

2025-11-17

Start date

2026-04-21

Completion date

2028-12-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

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.

Interventions

DRUGZG006

ZG006 will be administered as an IV infusion.

DRUGSerplulimab

Serplulimab will be administered as an IV infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing Dose-limiting toxicities (DLTs)	Up to Day 28
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to 2 Years

Secondary

Measure	Time frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Up to 2 Years
Maximum Serum Concentration (Cmax) of ZG006	Up to 2 Years
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006	Up to 2 Years

Countries

China

Contacts

CONTACTCong Zhang

zhangc@zelgen.com17602176888

STUDY_CHAIRJason Wu

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026