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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT06049966
Eligibility Criteria:
Cohorts A and B:
Inclusion Criteria:
* Histologically confirmed Stage IV (metastatic) or unresectable locally advanced LCNEC
* No prior treatment
* With or without brain metastasis, if symptomatic patients should be treated with WBRT first
* Performance Status ≤ 2
* Life expectancy \> 3 months
* Written informed consent
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Exclusion Criteria:
* Prior treatment with chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy (except WBRT for brain metastasis from LCNEC)
* Active or history of autoimmune disease or immune deficiency
* Treatment with systemic immunosuppressive medications with the following exceptions:
Patients who have received acute, low-dose systemic immunosuppressant medication (≤ 10 mg/day oral prednisone or equivalent) or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor approval has been obtained.
* Major surgical procedure other than for diagnosis within 4 weeks before initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Active malignancy or malignancy within 3 years
* Active tuberculosis
* Current severe, uncontrolled systemic disease other than cancer
* Known clinically significant liver disease
* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06049966
Study Brief:
Protocol Section:
NCT06049966