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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT03527251
Eligibility Criteria:
Inclusion Criteria:
* Age \>=18 years old, male or female;
* Histologically confirmed locally advanced or metastatic non-small-cell lung cancer;
* At least one systemic chemotherapy regimen for locally advanced or metastatic disease (patients received neoadjuvant chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy within 6 months can be considered as first-line system therapy);
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* At least one measurable lesion according to criteria RECIST v1.1;
* Life expectancy of at least 12 weeks;
* Patient has adequate bone marrow as defined by the following laboratory values:
White blood cell ≥ 3.0 × 109/L Absolute neutrophil count ≥ 1.5 × 109/L Platelets ≥ 75 × 109/L
* Patient has adequate organ function as defined by the following laboratory values:
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be \< 5 × ULN Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range of the central laboratory in patients with well documented Gilbert's Syndrome Serum creatinine ≤ 1.5 × ULN
* Provide written, informed consent to participate in the study and follow the study procedures;
* Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, ie, intrauterine device, bilateral tubal ligation, vasectomized partner, or abstinence (only when it is the preferred lifestyle of the patient), from the time of informed consent until 28 days after the last dose of the investigational products. Men and their female partners of childbearing potential must agree and commit to use a highly effective method of contraception (ie, any of the above methods or hormonal contraception associated with inhibition of ovulation) while on treatment and for 3 months after last dose of investigational products
Exclusion Criteria:
* Driver gene EGFR, ALK and ROS were positive;
* In presence of active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients with hormone replacement therapy can be included; Patients with vitiligo or asthma in childhood have been completely relieved, and no intervention in adults can be included; The subjects who needed medical intervention with bronchial dilation were ineligible;
* Patients are using immunity inhibitors or systemic hormone therapy for immunosuppression purpose (such as prednisone \> 10 mg/day), except for local hormone therapy.
* Patients were known to be allergic to macromolecular protein, or any components in ipilimumab or SHR-1210;
* Patients with clinical symptoms of central nervous system metastasis (e.g. brain edema, requirement of hormone intervention, or brain metastases progression);
* Another malignancy within 2 years prior to screening, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer;
* Patients with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (HBV DNA≥10⁴/ml);
* Any severe and / or uncontrolled medical conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03527251
Study Brief:
Protocol Section:
NCT03527251