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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07057102
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily signed the informed consent;
2. Aged 18 years or older;
3. Expected life expectancy of ≥3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1);
5. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) patients;
6. Classified as stage II, III, or IV according to the AJCC TNM staging system (9th edition);
7. Willing to provide blood samples and pre-treatment paraffin-embedded tissue samples;
8. With evaluable target lesions for efficacy assessment.
Exclusion Criteria
1. In the investigator's opinion, unsuitable for peripheral blood collection due to complications or other circumstances;
2. Active, known, or suspected autoimmune diseases (except vitiligo, type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to relapse without external stimulation);
3. Active tuberculosis (TB) infection confirmed by chest X-ray, sputum examination, and clinical physical examination. Patients with a history of active TB infection within the past 1 year, even if treated, will be excluded. Patients with a history of active TB infection more than 1 year ago will also be excluded unless they can demonstrate that previous antitubercular treatment was fully effective;
4. Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or local corticosteroids at immunosuppressive doses;
5. Pregnant or lactating;
6. Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg-positive and HBV-DNA \> 10³ copies/ml), or hepatitis C virus infection (HCV antibody-positive and HCV-RNA \> the lower limit of detection at the study center);
7. History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
8. Use of any antitumor-active drugs prior to blood sample collection;
9. Previous history of other malignancies (excluding non-melanoma skin cancer and the following in situ carcinomas: bladder, stomach, colon, endometrium, cervix/dysplasia, melanoma, or breast cancer);
10. Administration of live vaccines within 28 days prior to blood sample collection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07057102
Study Brief:
Protocol Section:
NCT07057102