Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.
Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.
• Age ≥18 years, no gender restrictions;
• Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a/b/c) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor/nodule size too large to be included in a tolerable radiation therapy plan;
• Participants have not received systemic treatment for extensive-stage SCLC;
• No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);
• ECOG performance status score of 0-2;
• Life expectancy ≥3 months;
• Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;
• Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:
⁃ Hemoglobin (Hb) ≥90g/L; Platelet (PLT) ≥100×10\^9/L; Neutrophil count (ANC) ≥1.5×10\^9/L; White blood cell count (WBC) ≥3.0×10\^9/L;
⁃ Lymphocyte ≥0.5×10\^9/L; b) Biochemistry:
⁃ Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g/dL;
⁃ Renal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL/minute (using Cockcroft/Gault formula); c) Coagulation:
⁃ Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase \>1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
• Female participants of childbearing potential must have a negative serum HCG test within 72 hours before the first dose, not breastfeeding, and must use a medically recognized contraceptive method (such as intrauterine devices, birth control pills, or condoms) during the study treatment and for 2 months after the last dose of Adebrelimab or 6 months after the last dose of Carboplatin/Etoposide (whichever is longer); male participants with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 2 months after the last dose of Adebrelimab or 3 months after the last dose of Carboplatin/Etoposide (whichever is longer), and no sperm donation during the study.