A Multicenter, Open-label, Randomized, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy
This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…\^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle. After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.
• Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable radiation plan).
• Clinically staged T1-2N0, operable LS-SCLC patients who are ineligible for surgery or refuse surgery.
• ECOG performance status 0-1. 5.Expected survival ≥ 3 months. 6.At least one measurable lesion per RECIST 1.1. 7.Pulmonary function: FEV1 \> 70% of predicted value. 8.Adequate hematologic and end-organ function, with laboratory results obtained within 7 days before first study treatment:
⁃ Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹/L; platelet count (PLT) ≥ 90×10⁹/L without transfusion, G-CSF, or other hematopoietic stimulants within 14 days before first treatment.
⁃ Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for patients with confirmed Gilbert syndrome).
⁃ Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation); urine protein \< 2+ (if urine protein ≥ 2+, 24-hour urine protein must be \< 1 g for eligibility).
⁃ Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
⁃ Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Sexually active subjects of reproductive potential (non-sterilized) must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after treatment completion. For females of reproductive potential: serum pregnancy test (HCG) must be negative within 7 days before first dosing.
⁃ Subjects are voluntarily enrolled, provide written informed consent, have good compliance, and agree to follow-up.