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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT07129161
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 9th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
* MDT assessment (including a thoracic surgeon) confirms resectability.
* Provision of tumor tissue for biomarker analysis (e.g., PD-L1 testing, gene sequencing).
* At least one measurable lesion per RECIST v1.1.
* ECOG performance status 0 or 1.
Exclusion Criteria:
* Confirmed EGFR or ALK mutations.
* Other malignancies within 5 years (exceptions: adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical surgery, ductal carcinoma in situ post-radical surgery).
* Prior treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors, CTLA-4 inhibitors) or immunostimulatory antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or anti-tumor immune cell therapy.
* Use of immunosuppressants or systemic corticosteroids (\>10 mg/day prednisone equivalent) within 2 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07129161
Study Brief:
Protocol Section:
NCT07129161