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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06000358
Eligibility Criteria:
Inclusion Criteria:
* Patients with Eastern Cooperative Oncology Group (ECOG) performance score 0 - 1;
* Patients with histologically confirmed metastatic non-small cell lung cancer and PD-L1 expression on tumor cells was evaluated;
* CT examination shows measurable tumor formations according to the RECIST 1.1 criteria;
* Primary lung tumor or metastasis accessible to flexible bronchoscopy;
* Patients may have received surgery, adjuvant or neoadjuvant chemotherapy prior to the study if it was completed at least 12 months before relapse;
* Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion Criteria:
* Patients who refused to participate in the clinical trial and did not sign the informed consent form;
* Men and women under the age of 18, pregnant women;
* Patients belonging to a vulnerable social group;
* High risk of general anesthesia, defined as American Society of Anesthesiologists (ASA) class 4 - 6;
* Documented allergy to medications used during general and local anesthesia, systemic cancer treatment;
* Patients previously treated with immune checkpoint inhibitors;
* EGFR mutations or ALK translocations have been identified in patients;
* Patients with previously diagnosed autoimmune diseases, active viral hepatitis, uncontrolled human immunodeficiency virus (HIV) infection or untreated tuberculosis;
* Patients treated with immunosuppressive drugs, systemic corticosteroids, with equivalent doses of prednisolone exceeding 10 mg/day;
* Patients with an increased risk of bleeding during an interventional procedure;
* Acute untreated conditions that would make it impossible to perform an interventional lung procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06000358
Study Brief:
Protocol Section:
NCT06000358