This multicenter, prospective study aims to investigate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy plus anti-PD-L1 antibody, followed by anti-PD-L1 antibody maintenance for up to two years, in participants with extensive-stage small cell lung cancer (ES-SCLC).
Additionally, dynamic monitoring using next-generation sequencing (NGS) technology will be performed to assess ctDNA levels, genetic information, and mutation abundance at the following time points: before and after low-dose radiotherapy, after 4-6 cycles of chemotherapy plus anti-PD-L1 antibody (chemotherapy-immunotherapy), and before the initiation of anti-PD-L1 maintenance therapy. This approach aims to guide efficacy and prognosis prediction, as well as to identify potential biomarkers associated with treatment response.
Age ≥18 years and ≤75 years.
Histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC).
No prior systemic anti-tumor therapy.
ECOG performance status 0-2 and life expectancy ≥12 weeks.
Presence of interstitial pneumonia or infectious fever prior to treatment.
Comorbid autoimmune diseases or long-term oral corticosteroid use (including those who received oral corticosteroids within 14 days prior to treatment).
Prior history of thoracic radiotherapy or thoracic surgery.
Presence of Grade ≥3 hematologic toxicity or hepatic/renal impairment.
Single group
Etoposide
DrugEtoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Cisplatin
DrugEtoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Carboplatin
DrugEtoposide 100 mg/m² intravenously on days 1-3, plus Carboplatin area under the curve (AUC) 5 intravenously on day 1, repeated every 21 days (q3w).
Adebrelimab
Drug20 mg/kg intravenously on day 1, repeated every 21 days (q3w). Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years.
Thoracic Radiotherapy
RadiationRadiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions.
Progression-Free Survival（PFS）
Time from first radiotherapy to first occurrence of disease relapse/progression (RECIST 1.1), metastasis, or death from any cause.
Overall Survival (OS)
Time from first radiotherapy to death from any cause.
Overall Response Rate (ORR)
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
Disease Control Rate (DCR)
Proportion of subjects achieving CR, PR, or stable disease (SD) according to RECIST v1.1.
Incidence of Treatment-Emergent Adverse Events
Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.
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