Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

Exclusion Criteria21

• Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);
• Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;
• Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;
• Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;
• Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;
• Clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments;
• Active, known, or suspected autoimmune disease;
• Use of corticosteroids (doses\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug;
• Receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug;
• Interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction;
• Active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated;
• Any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to CTCAE v5.0) prior to the first dose of the investigational drug;
• Underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug;
• Presence of uncontrolled cardiovascular symptoms or diseases;
• Hypersensitivity to the investigational drug or its excipients;
• A history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma;
• A history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse;
• HBsAg-positive and HBV DNA levels exceeding the upper limit of normal, or HCV-positive (HCV RNA or HCV Ab indicating acute or chronic infection); a history of HIV-positive status or acquired immunodeficiency syndrome (AIDS);
• Received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (ICF);
• A history of allogeneic bone marrow transplantation or solid organ transplantation;
• Any other factors as determined by the investigator.