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Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer
Sponsor: Jiangmen Central Hospital
Summary
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.
Official title: Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2026-05-01
Completion Date
2028-01-01
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Etoposide
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Cisplatin
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Carboplatin
Etoposide 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
20 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
Radiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions.