lung cancer
Conditions
Interventions
single arm:Adebrelimab
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. patients with histologically or cytologically confirmed non-squamous NSCLC with brain metastases; 2. age = 18 years, male or female; 3. ECOG PS 0-2; 4. Expected survival = 12 weeks; 5. MRI-confirmed brain metastases and number of brain lesions = 3; or patients with 1-2 brain lesions unsuitable for or refusing local therapy. At least one measurable lesion = 5 mm in diameter in the number of intracranial lesions; 6. no prior systemic therapy for metastatic non-small cell lung cancer; chemotherapy and/or radiotherapy as part of neoadjuvant/adjuvant therapy is permitted, provided that the interval between the end of surgery and the diagnosis of advanced or metastatic disease is not less than 6 months 7. Vital organ function within 1 week prior to enrollment meets the following criteria: (1) blood routine: absolute neutrophil count (absolute neutrophil count, ANC) = 1.5 × 109/L; platelet (PLT) = 100 × 109/L; hemoglobin content (hemoglobin, HGB) = 90 g/L; no blood transfusion or EPO dependence within 7 days; (2) Liver function: aspartate transferase (AST) = 2.5 × ULN, alanine aminotransferase (ALT) = 2.5 × ULN, ALT and AST = 5 × ULN in liver metastasis subjects. AST = 5 × ULN; serum total bilirubin (total bilirubin, TBIL) = 1.5 × ULN; albumin (ALB) = 30.0 g / L (3) renal function: serum creatinine = 1.5 × ULN or creatinine clearance rate (CrCl) = 60 mL / minute (cockcockcurve). /minute (Cockcroft/Gault formula); urinary protein < 2+ in routine urine; if the patient has urinary protein = 2+ at baseline, 24-hour urine should be collected for testing to ensure that the quantitative 24-hour urinary protein is = 1 g; (4) coagulation function: international normalized ratio (international normalized ratio, INR) (4) Coagulation function: international normalized ratio (INR) = 1.5 × ULN, activated partial thromboplastin time (APTT) = 1.5 × ULN; 8. Female patients who are non-surgically sterilized or of childbearing potential must have a negative serum HCG test within 72 hours prior to the first dose of study drug and must not be lactating, and must agree to use appropriate contraception (e.g., IUD, birth control pills, or condoms, etc.) during the study treatment period and for 3 months after the end of the study treatment period; male patients agree to use appropriate method of contraception; 9. Sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. adenosquamous cell lung cancer with mixed non-small cell and small cell carcinoma or adenocarcinoma component < 50% (if adenocarcinoma component is = 50%, inclusion criteria are met) 2. currently enrolled in an interventional clinical trial or being treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose; and 3. patients who have received prior systemic antitumor therapy; and 4. Patients who have received a solid organ or hematologic transplant; and 5. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy; and 6. diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose; physiologic doses of glucocorticosteroids (prednisone or equivalent = 10 mg / day) are permitted; and 7. History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to first dose; 8. known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive) 9. untreated active hepatitis B; patients with hepatitis B who meet the following criteria are also eligible for inclusion:(1) HBV viral load must be < 500 IU/ml prior to the first dose, and anti-HBV therapy should be at the discretion of the investigator throughout the course of the study in order to avoid viral reactivation; and (2) for patients with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load (-) subjects, prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed; 10. subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection);. 11. pregnant and lactating women; 12. known hypersensitivity to adebelizumab, pemetrexed, carboplatin, or any of the excipients. 13. malignancies other than NSCLC within 5 years prior to enrollment, except adequately treated cervical cancer in situ, basal cell or squamous epithelial cell skin cancer, limited prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery. 14. Exclude patients with active tuberculosis (TB). Chest X-ray, sputum examination and clinical signs and symptoms are required to exclude suspected active TB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iORR;iDCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| iPFS;iDoR;iTTR;eORR;ORR;DCR;PFS;DoR;TTR;OS; | — |
Countries
CHINA
Contacts
Public ContactKAIHUA LU
Jiangsu Provincial People's Hospital
Outcome results
None listed