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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT03983759
Eligibility Criteria:
Inclusion Criteria:
* small cell lung cancer confirmed by pathology
* extensive small cell lung cancer by imaging
* at least one measurable lesion by RECIST 1.1
* ECOG 0-1
* adequate organ function
* no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
* no history of other maliganancies
* Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
* agreement to participate in the study and signed informed consent from the patients
Exclusion Criteria:
* serious infectious diseases four weeks before enrollment
* requirement intermittent use of bronchodilators or medical interventions;
* the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
* severe allergies
* severe mental disorders
* abnormal coagulation function
* previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
* other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03983759
Study Brief:
Protocol Section:
NCT03983759