This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.
1. Age 18-75 years, male or female;
2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition);
3. No more than 2 cycles of chemotherapy or no previous systemic therapy;
4. ECOG PS 0-1;
1. Histological mixture of SCLC and NSCLC components;
2. Extensive-stage SCLC;
3. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planned for transplantation;
4. Treatment with immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days prior to the first dose of PD-L1 inhibitor, except for intranasal and inhaled corticosteroids or low-dose systemic steroids (i.e., ≤10 mg/day prednisolone or equivalent);
LS-SCLC with PD-L1 inhibitor after Chemoradiotherapy
Cohort
Prospective
Etoposide + cisplatin/carboplatin
DrugFour courses of intravenous cisplatin (75 mg/m² of body surface area on day 1 or divided into 3 days of each cycle) or carboplatin (area under the curve of 5 mg/mL per min on day 1 of each cycle) and intravenous etoposide (100 mg/m² of body surface area on days 1-3) every 3 weeks
Thoracic radiotherapy
RadiationHigh-dose, accelerated, hyperfractionated, twice-daily thoracic radiotherapy (54 Gy in 30 fractions) concurrent with chemotherapy initiated at the beginning of cycles 1-3
Prophylactic cranial irradiation (PCI)
RadiationPCI (25Gy in 10 fractions, once daily over two weeks) 3-4 weeks post-chemoradiotherapy for patients achieving PR or CR
PD-L1 inhibitor
DrugMaintenance therapy with PD-L1 inhibitors (Durvalumab 1500 mg Q4W or Atezolizumab 1200 mg Q3W or Sugemalimab 1200 mg Q3W or Adebrelimab 1200 mg Q3W) post-PCI until disease progression, death, or intolerable toxicity, up to 2 years
Progression-free survival
The time from enrollment to disease progression or death due to any cause, whichever occurs first.
Overall survival
The time from enrollment to death due to any cause.
Objective response rate
The percentage of participants who have a CR or a PR, as determined by investigators according to RECIST v1.1.
Disease control rate
The percentage of participants who have a CR, a PR or a SD, as determined by investigators according to RECIST v1.1.
Incidence and severity of adverse events
Blood biomarker analysis
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