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.
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.
Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.
Extensive-stage SCLC.
Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells.
Parallel
CCRT(Employed residual field irradiation(RFI))
Other interventionCarboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic radiotherapy(employed residual field irradiation, RFI), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
CCRT(Involved-Field Radiotherapy (IFRT))
Other interventionCarboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
PFS
progression-free survival: Time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
L-PFS
local progression-free survival: Time from start of concurrent CCRT to first local progression post-maintenance or all-cause death, whichever occurs first
M-PFS
Metastasis-Progression Free Survival (M-PFS): Defined as the time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective distant tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
OS
Overall Survival (OS): The time from the date of initiating study treatment at enrollment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last known alive.
DCR
Disease Control Rate (DCR): The proportion of patients with tumor shrinkage or stabilization maintained for a specified duration, including subjects with Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
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