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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT06939127
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years at informed consent signing.
* ECOG performance status of 0 or 1.
* Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
* Tumor size ≤5 cm.
* Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
* Adequate cardiopulmonary function for radical surgical resection.
* Eligible for cryoablation and platinum-based doublet chemotherapy.
* Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.
Exclusion Criteria:
* Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
* LCNEC diagnosis.
* Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.
For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.
* Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
* History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
* Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
* Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
* Active autoimmune disease or history of recurrent autoimmune disease.
* Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
* Severe infections requiring systemic treatment within the past 4 weeks.
* Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06939127
Study Brief:
Protocol Section:
NCT06939127