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NCT Number: NCT07038096

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

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Key information

Conditions

Small Cell Lung Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Neuroendocrine Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Carcinoma Neuroendocrine Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

Location status: Recruiting

Location contact

Li Zhang

CONTACT

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 18-70 years of age.
  • Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Life expectancy > 3 months.

Exclusion criteria

  • The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Treatment and study plan

ZG006

Drug

ZG006 will be administered as an intravenous (IV) infusion.

ZG005

Drug

ZG005 will be administered as an intravenous (IV) infusion.

Primary outcomes

  1. Number of Participants Who Experienced Dose-limiting Toxicity (DLT)

    Time frame: up to 28 days

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

    Time frame: Up to 2 years

  3. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: Up to 2 years

  2. Disease Control Rate (DCR)

    Time frame: Up to 2 years

  3. Progression-free Survival (PFS)

    Time frame: Up to 2 years

  4. Overall Survival (OS)

    Time frame: Up to 2 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 Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 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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