Extensive-stage small cell lung cancer (ES-SCLC)
Conditions
Interventions
Experimental group:Adebrelimab Combined with Chemotherapy and Concurrent Radiotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years, both male and female, with an ECOG PS of 0-1; 2.histologically or cytologically con?rmed SCLC; 3.Staged as extensive-stage small cell lung cancer (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) criteria; 4.had no previous systemic treatment or any treatment with immune checkpoint inhibitors (ICIs) for first-line systemic therapy; 5.The subject is deemed by the investigator to be an appropriate candidate for treatment with Adebrelimab in combination with EP/EC and concurrent radiotherapy.. 6.had measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST, version 1.1); 7.Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Both female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use highly effective contraception from signing the informed consent form until 24 weeks after the last dose of the study drug; 8. Sufficient liver and kidney function; (1) Blood routine (no blood transfusion or use of hematopoietic growth factor drugs to correct within 14 days before screening): White blood cell count (WBC) >= 3.0 × 10^9 /L; Absolute neutrophil count (ANC) >= 1.5 × 10^9 /L; Platelet count (PLT) >= 100 × 10^9 /L; Hemoglobin (HGB) >= 9.0 g/dL; (2) Liver function: For subjects without liver metastases, aspartate aminotransferase (AST) = 50 mL/minute (using Cockcroft/Gault formula); (4) Coagulation function: International normalized ratio (INR) 1.5 x ULN can be enrolled if there is no clinical or imaging evidence of pancreatitis); Amylase 1.5 x ULN can be enrolled if there is no clinical or imaging evidence of pancreatitis); Alkaline phosphatase (ALP) <= 2.5 x ULN, for subjects with liver or bone metastases, ALP <= 5 x ULN; 9.Having signed the informed consent form and voluntarily joined this study, with good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Active or untreated central nervous system (CNS) metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period or on historical radiographic assessments; 2.Multiple bone metastases (>=3 lesions) confirmed by bone scan; 3.Symptomatic third-space fluid accumulation requiring repeated drainage (e.g., pericardial effusion, pleural effusion, or ascites) that remains uncontrolled despite therapeutic paracentesis or other interventions; 4.Having received any other investigational drug(s) or participation in another interventional clinical study within 4 weeks prior to signing the ICF; 5.Known history of allergy to the investigational drug(s) or their excipients; or known history of severe hypersensitivity reactions to any monoclonal antibody; 6.Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell-targeting agents; 7.HBsAg positive with HBV DNA levels exceeding the upper limit of normal (ULN) at the local laboratory (>1000 copies/mL or >500 IU/mL); or HCV positive (indicating acute or chronic infection as confirmed by HCV RNA or HCV Ab testing); or known history of HIV infection or acquired immunodeficiency syndrome; 8.History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or clinically active pneumonitis; or other moderate to severe pulmonary diseases that significantly impair lung function. (Patients with a history of radiation pneumonitis/fibrosis confined to the radiation field are permitted to enroll.); 9.History of other malignant tumors within <=5 years prior to the first dose, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative resection, or ductal carcinoma in situ (DCIS) treated with curative resection (hormonal therapy for non-metastatic prostate cancer or breast cancer is permitted); 10.Judgment by the Investigator that the patient should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Objective response rate, ORR;Duration of Response, DoR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYan Li
West China Hospital of Sichuan University
Outcome results
None listed