ZG006 plus ZG005 for advanced small cell lung cancer and neuroendocrine carcinoma
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)
This trial tests whether the combination of ZG006 and ZG005 helps adults with advanced small cell lung cancer or neuroendocrine carcinoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT07038096 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guanzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hewen Yin
- Email: yinhw@zelgen.com
- Phone: +86-0512-57309965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.