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 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT02848651
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed Stage IIIB-IVB NSCLC
* For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
* Participants with any programmed death-ligand 1 (PD-L1) test result by immunohistochemistry (IHC) are eligible for the study
* Participants without a PD-L1 test result are eligible for the study
* Measurable disease per RECIST v1.1
* Adequate hematologic and end-organ function
* Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential
Exclusion Criteria:
* Prior treatment with immunotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
* Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and anaplastic lymphoma kinase (ALK) rearrangements
* Active central nervous system (CNS) metastases requiring treatment
* Spinal cord compression not definitively treated or not clinically stable
* Leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Malignancies other than NSCLC within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death
* Pregnant or lactating women
* History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
* Positive human immunodeficiency virus (HIV) or hepatitis B or C
* Active tuberculosis
* Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment within 2 weeks prior to enrollment
* Prior treatment with or hypersensitivity to study drug or related compounds
* Prior allogeneic bone marrow or solid organ transplant
* Administration of a live, attenuated vaccine within 4 weeks prior to enrollment
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to enrollment
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02848651
Study Brief:
Protocol Section:
NCT02848651