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NCT Number: NCT07189455

Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).

Recruiting

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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 3

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

  • 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;
  • Histologically or cytologically confirmed Small Cell Lung Cancer.

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 intravenous (IV) infusion.

Topotecan

Drug

Topotecan will be administered per local standard of care

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 3 years

  2. Serum Concentrations of ZG006

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hewen Yin

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2025
Registry last updated
Jan 5, 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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