Non-small cell lung cancer
Conditions
Interventions
Treatment group:Adebrelimab plus chemotherapy
Sponsors
Taihe hospital,Affiliated hospital of hubei university of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old, both male and female; 2. Late stage (stage IV) non-small cell lung cancer confirmed by histology or cytology; 3. ECOG physical condition score 0-1 points; 4. Have not received first-line systemic therapy or immune checkpoint inhibitors for NSCLC in the past; 5. Subjects who have previously received neoadjuvant/adjuvant chemotherapy, curative surgery, radiation therapy, or radiochemotherapy for non metastatic tumors with the aim of cure shall have been treated for at least 6 months from the end of the last course of chemotherapy, curative surgery, radiation therapy, or radiochemotherapy until randomization. 6. At least one measurable lesion (RECIST 1.1 standard); 7. The research center must be able to provide relevant documentation on the EGFR mutation and ALK translocation status of the subjects, and both must be negative; 8. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication, and the result should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication; Before the first dose of the investigational drug, the laboratory test values meet the following conditions: (1) Blood routine (no blood transfusion or use of hematopoietic stimulating factor drugs within 14 days prior to screening): White blood cell count (WBC) = 3.0 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelet (PLT) = 100 × 109/L; Hemoglobin content (HGB) = 9.0g/dL; (2) Liver function: Aspartate aminotransferase (AST) = 2.5xULN in subjects without liver metastasis; Alanine aminotransferase (ALT) = 2.5xULN, and ALT and AST = 5xULN in liver metastasis subjects; Total bilirubin (TBIL) in serum = 1.5xULN (excluding Gilbert syndrome with TBIL = 3.0mg/dL); (3) Renal function: serum creatinine = 1.5xULN or creatinine clearance rate (CrCl) = 50mL/minute (using Cockcroft/Gout formula, refer to Attachment 2); (4) Coagulation function: International normalized ratio (INR) = 1.5xULN, activated partial thromboplastin time (APTT) = 1.5xULN (only applicable to patients who have not received anticoagulant treatment currently, stable dose anticoagulant treatment should be received for patients who are currently receiving anticoagulant treatment); (5) Other: lipase = 1.5xULN (if lipase>1.5xULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the group); Amylase = 1.5xULN (if amylase>1.5xULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the group); Alkaline phosphatase (ALP) = 2.5ULN, for subjects with liver or bone metastasis, ALP = 5ULN; 10. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune diseases or a history of autoimmune diseases; 2. Exclude subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage; 3. The subject has an active infection or an unexplained fever>38.5 degrees Celsius during the screening period or before the first administration; 4. Those who have used other clinical trial drugs within 4 weeks before the first medication use; 5. Within less than 4 weeks before the study medication or possibly during the study period, live vaccines may be administered; 6. Individuals who are allergic to immunosuppressants, anti angiogenesis and any excipients, as well as pemetrexed and carboplatin chemotherapy drugs; According to the judgment of the researchers, there are other factors that may cause the subjects to be forced to terminate this study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, and family or social factors, which may affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR;Overall survival, OS;Disease control rates, DoR;Safety; | — |
Countries
China
Contacts
Public ContactMing Luo
Taihe hospital,Affiliated hospital of hubei university of medicine
Outcome results
None listed