Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
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, Serplulimab.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer. Basic parameters: 18 years — 75 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 Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
Overview
This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.
Interventions
- Drug ZG006
ZG006 will be administered as an IV infusion. - Drug Serplulimab
Serplulimab will be administered as an IV infusion.
Primary outcome measures
- Number of Participants Experiencing Dose-limiting toxicities (DLTs) [Time frame: Up to Day 28]
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 2 Years]
Secondary outcome measures (3)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time frame: Up to 2 Years]
- Maximum Serum Concentration (Cmax) of ZG006 [Time frame: Up to 2 Years]
- Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006 [Time frame: Up to 2 Years]
Eligibility criteria
Inclusion criteria
- Participants with histologically or cytologically confirmed ES-SCLC.
- 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;
Exclusion criteria
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07231445 · ZG006-004