Small cell lung cancer
Conditions
Interventions
Test Group:Adebrelimab Injection
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Age: 18-75 years old, gender not limited 2: Extensive-stage small cell Lung cancer confirmed by histology or cytology (according to the Veterans Administration Lung Study Group, VALG staging) 3: The ECOG physical condition score ranges from 0 to 1 4: Previously, no first-line systemic treatment for ES-SCLC, treatment with immune checkpoint inhibitors, or targeted anti-vascular therapy was received 5: Previous surgical treatment followed by adjuvant therapy aimed at cure such as radiotherapy and chemotherapy, and there was at least a 6-month treatment-free interval from the last chemotherapy, radiotherapy or chemoradiotherapy to the diagnosis of extensive-stage SCLC with normal major organ function, that is, meeting the following criteria (no symptomatic treatment within 14 days) 6: Patients with asymptomatic central nervous system metastases can be included 7: The expected survival time is >=12 weeks 8: A measurable lesion as defined in RECIST standard v1.1: A previously irradiated lesion that shows clear disease progression after radiotherapy and is not the only lesion can be considered a measurable lesion 9: Women of childbearing age must undergo serum pregnancy within 7 days before the first medication, and the result must be negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to contraception from the signing of the informed consent form until 24 weeks after the last administration of the study drug 10: Before the first dose of the study drug, the laboratory test values meet the following conditions: (1) blood routine (no blood transfusion and no correction of hematopoietic stimulating factor drugs within 14 days before screening) : white blood cell count (WBC) >=3.0 × 10^9/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelet (PLT) >=100 × 10^9/L; The hemoglobin content (HGB) is >=9.0 g/dL. (2) Liver function: aspartate transferase (AST) =50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: international normalized ratio (INR) 1.5 x ULN without clinical or radiological confirmation of pancreatitis, enrollment can be conducted); Amylase 1.5 x ULN without clinical or imaging confirmation of pancreatitis, enrollment can be carried out); alkaline phosphatase (ALP) <=2.5 x ULN in subjects with liver metastasis or bone metastasis, ALP <=5 x ULN 11: The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up
Exclusion criteria
Exclusion criteria: 1. Allergic to the test drug 2. Patients who have transformed from non-small cell carcinoma (NSCLC) to SCLC or SCLC with mixed histology; 3. Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices for treatment within 4 weeks prior to the first administration; 4. Have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 5. Symptomatic brain metastases 6. Untreated and asymptomatic patients with brain metastases who are eligible for inclusion or exclusion; 7. Have received solid organ or blood system transplants; 8. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that cannot be controlled after pumping or other treatments; 9. Poorly controlled tumor-related pain: 10. Poorly controlled or symptomatic hypercalcemia; 11. Had suffered from any disease that required systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment in the group; 12. Adverse reactions caused by previous treatments have not been restored to CTCEA(Version 5.0) grade 1 or below 13. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related lung toxicity and seriously affect respiratory function; 14. Severe infection occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia; 15. Severe chronic or active infections (including pulmonary tuberculosis infection, etc.) that require systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment; 16. For any other reason, outpatients (or inpatients) who are making their first visit (or follow-up visit) at hospitals that the researchers consider unsuitable to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 6-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief, DoR;Disease control rate, DCR;Progression-free survival, PFS;Objective response rate, ORR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactZhang Lemeng; Luo Yongzhong
Hunan Cancer Hospital
Outcome results
None listed