Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT06585059
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
* Locally advanced or metastatic NSCLC diagnosed by histology or cytology
* The major organs are functioning well；
* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.
Exclusion Criteria:
* Current concomitant presence of other malignancies within 5 years prior to the first dose;
* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
* Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
* Long-term unhealed wounds or fractures;
* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
* Subjects with any severe and/or uncontrolled disease;
* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
* Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;
* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06585059
Study Brief:
Protocol Section:
NCT06585059