ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG006, ZG005.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer, Neuroendocrine Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug ZG006
ZG006 will be administered as an intravenous (IV) infusion. - Drug ZG005
ZG005 will be administered as an intravenous (IV) infusion.
Primary outcome measures
- Number of Participants Who Experienced Dose-limiting Toxicity (DLT) [Time frame: up to 28 days]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 2 years]
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (4)
- Duration of Response (DOR) [Time frame: Up to 2 years]
- Disease Control Rate (DCR) [Time frame: Up to 2 years]
- Progression-free Survival (PFS) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guanzhou
Identifiers
NCT: NCT07038096 · ZG006-ZG005-001