Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 70

ZG006 plus ZG005 for advanced small cell lung cancer and neuroendocrine carcinoma

Official 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)

Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT07038096 · Data updated 2026-11-12

This trial tests whether the combination of ZG006 and ZG005 helps adults with advanced small cell lung cancer or neuroendocrine carcinoma.

More Small Cell Lung Cancer trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment350 (estimated)
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Industry-sponsored
Locations1 site (Guanzhou, Guangdong)
StatusRecruiting
StartedSeptember 23, 2025
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedJanuary 5, 2026
Trial IDNCT07038096 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to 70 with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by pathology, ECOG 0-1, and expected survival beyond three months are the intended participants.

Probably not a fit

Patients with poor performance status (ECOG 2 or higher), significant comorbidities, or other investigator-determined contraindications are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter Phase Ib/II trial gives the investigational agents ZG006 and ZG005 together to adults with advanced small cell lung cancer or neuroendocrine carcinoma to define safety and early activity. Eligible participants have histologically or cytologically confirmed disease, ECOG performance status 0-1, are aged 18-70, and have life expectancy over three months. The protocol includes dose and safety monitoring, imaging to measure tumor response, and collection of adverse event and survival data to establish a recommended phase II dose and preliminary efficacy signals. Enrollment and treatment are conducted at Sun Yat-sen University Cancer Center with scheduled clinical and radiologic follow-up per protocol.

Why it matters

Potential benefit: If successful, the combination could produce better tumor control or longer progression-free survival than existing options for this hard-to-treat population.

How similar studies have gone: Combination approaches in small cell lung cancer have produced mixed results historically, and this specific ZG006 plus ZG005 combination is novel with limited prior human data.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Sun Yat-sen University Cancer Center
    Guanzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.