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NCT Number: NCT07231445

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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG006

Drug

ZG006 will be administered as an IV infusion.

Serplulimab

Drug

Serplulimab will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants Experiencing Dose-limiting toxicities (DLTs)

    Time frame: Up to Day 28

  2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 2 Years

Secondary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to 2 Years

  2. Maximum Serum Concentration (Cmax) of ZG006

    Time frame: Up to 2 Years

  3. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006

    Time frame: Up to 2 Years

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 17, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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