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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT04372732
Eligibility Criteria:
Inclusion Criteria:
1. The subjects understood the requirements and risks of the study fully and signed the informed consent form.
2. Aged between 18 and 70 years;
3. Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer.
4. Immunohistochemistry of pathological tissue: PD-L1 (22C3) ≥ 1%,Gene detection EGFR (-); ALK (-), ROS1 (-).
5. All of these patients have no surgical indications or radical radiotherapy guidelines.
6. ECOG PS score 0-1, life expectancy not less than 12 weeks.
7. According to RECIST1.1,there is at least one tumor site that can be accurately measured by CT in patients.
8. Women of childbearing age had negative pregnancy tests and were willing to accept drugs or intrauterine contraception, while men of childbearing age were willing to accept contraception voluntarily.
9. Adequate hematologic function:Peripheral blood neutrophil count \> 2000 cells / uL, Platelet count \> 100\*109 / L; Hemoglobin \>9.0g/dL;Blood total bilirubin \< 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;Inosine clearance ≥ 60ml / min.
Exclusion Criteria:
1. Subjects who needed to receive systemic corticosteroids (prednisone equal to or higher than 10mg / day) or other immunosuppressive drugs within 14 days before enrollment or during the study.
2. Subjects who had been vaccinated with antineoplastic vaccine or received antineoplastic drugs with immunostimulatory effect within 4 weeks before entering the group.
3. Subjects with known or suspected active autoimmune diseases (vitiligo, type I diabetes, autoimmune thyroiditis requiring hormone replacement therapy, and other autoimmune diseases without recurrence can also be included).
4. Subjects with other tumors in the past 5 years, except cervical carcinoma in situ, basal cell carcinoma of the skin, etc.
5. Subjects with any unstable systemic diseases (including active infections, poorly controlled hypertension, unstable angina pectoris, angina pectoris that occurred in the past 3 months, congestive heart failure (or New York Heart Association (NYHA) II)), infarcts (within 6 months), severe arrhythmias requiring medication, liver, kidney or metabolic diseases.
6. Subjects with previous or present interstitial lung diseases.
7. Subjects with systemic infection who need to be treated, HBV surface antigen positive or HCV RNA positive; patients who have previously or currently detected human immunodeficiency virus (HIV) or AIDS.
8. Subjects who received targeted therapy or biotherapy at the same time.
9. Subjects who are allergic to therapeutic drugs (chemotherapeutic drugs and immune drugs);
10. Subjects who underwent major surgery or suffered severe trauma within 2 months before the first treatment;
11. Situations that other researchers do not consider appropriate to be included.
12. Subjects whose expected survival time is less than 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04372732
Study Brief:
Protocol Section:
NCT04372732