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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04654234
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed, written and dated informed consent prior to any study specific procedures;
* Patients aged 18\~75 years old;
* had histologically or cytologically confirmed non-small cell lung cancer;
* Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
* Life expectancy ≥12 weeks;
* World Health Organization (WHO) Performance Status of 0 or 1;
* had unresectable stage III disease according to the 8th edition of the American Joint Committee on Cancer staging system;
* Women should be non-breast feeding during the study period;
* Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study treatment and for a period of 5 months following the last administration of the study treatment;
* Men who have sex with WOCBP must agree to comply with the contraceptive method during the study treatment and for 7 months after the last administration of the study treatment;
* Absolute neutrophil count ≥1500/uL, hemoglobin ≥9.0mg/dL, platelet ≥100000/uL;
* Serum creatinine clearance \>50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976);
* Serum bilirubin ≤1.5 x upper limit of normal (ULN), Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN;
* Forced expiratory volume in 1 second (FEV1) ≥800ml;
Exclusion Criteria:
* Concurrent enrollment in another clinical study, unless it is an observational(non-interventional) clinical study;
* Mixed small cell and non-small cell lung cancer histology;
* Prior exposure to any anti-programmed cell death protein(PD)-1 or anti- PD-L1 antibody;
* Active or prior documented autoimmune disease within the past 2 years;
* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
* History of primary immunodeficiency;
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses;
* History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
* Any situation not suitable for this study judged by researchers;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04654234
Study Brief:
Protocol Section:
NCT04654234