Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.
This exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.
Age: 18-75 years, both genders are eligible;
Histologically or cytologically confirmed limited-stage small cell lung cancer (according to the 8th edition of AJCC staging);
Patients who have previously received no more than 2 cycles of standard chemotherapy or are treatment-naive;
ECOG performance status: 0-1;
Histological mixture of SCLC and NSCLC components;
Extensive-stage SCLC;
Patients with a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant or planned for transplant;
Use of immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 14 days before the first use of Adebrelimab, excluding nasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisolone or equivalent physiologic dose of other corticosteroids);
Single group
Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy
DrugChemotherapy: Etoposide will be administered intravenously at a dose of 100 mg/m² on days 1 to 3 of each cycle. Cisplatin will be given at a dose of 75 mg/m² on day 1 of each cycle. The treatment will be repeated every 3 weeks for a total of 4 cycles. Concurrent Radiotherapy: Chest radiotherapy will be initiated concurrently with the first 3 cycles of chemotherapy. The total dose of radiotherapy will be 54 Gy, delivered in 30 fractions, with 2 fractions per day. Prophylactic Cranial Irradiation (PCI): For patients who achieve a partial response (PR) or complete response (CR) after chemoradiotherapy, PCI will be administered 3 to 4 weeks after the completion of chemoradiotherapy. The dose for PCI will be 25 Gy in 10 fractions. Adebrelimab Maintenance Therapy: Following PCI, patients will receive maintenance therapy with Adebrelimab. The dose will be 1200 mg administered intravenously on day 1 of each cycle. The treatment will be repeated every 3 weeks until disease progression, death
Treatment-related adverse events
Treatment-related adverse events according to CTCAE 5.0
PFS
From the date of enrollment to the date of disease progression
OS
from the date of enrollment until death by any cause or last follow-up
ORR
The proportion of subjects with Best Overall Response (BOR) assessed as Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria
DCR
DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
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