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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06462105
Eligibility Criteria:
Inclusion Criteria:
* Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)；
* Age ≥18 years；
* Patients with pathologically or histologically confirmed extensive stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging system)；
* The patient had not previously received any form of antitumor therapy；
* According to RECIST1.1 criteria, the patient had at least one measurable target lesion；
* Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2；
* The expected survival time is ≥3 months；
* Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, and hemoglobin ≥90 g/L (no blood transfusion, blood products, correction with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 14 days prior to laboratory examination)；
* Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)；
* Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial period and for 6 months after the last dose of the test drug.
Exclusion Criteria:
* Patients with large cell neuroendocrine tumor and mixed small cell carcinoma；
* Patients with active brain metastases or central nervous system invasion； confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥10mg)；
* Allergic reaction to any investigational drug or its ingredients；
* The patient has previously received other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, CTLA4, etc；
* Serious, uncontrolled comorbidities that could affect the study results, including but not limited to serious infections, diabetes, or cardiovascular and cerebrovascular disease, were identified；
* Imaging confirmed intestinal obstruction；
* It has uncontrollable ascites, abdominal infection and pyloric obstruction；
* Cardiac function and disease: a history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities in the 6 months prior to recruitment；
* Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA)；
* Human immunodeficiency virus (HIV) infection (HIV antibody positive);
* Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
* Pregnant and lactating women and patients of childbearing age who do not want to use contraception;
* The investigators determined that patients were not suitable to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06462105
Study Brief:
Protocol Section:
NCT06462105