A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC

Prior treatment

• Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
• Severe infection within 4 weeks prior to the initiation of study treatment.
• Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination.
• Prior treatment with immune checkpoint inhibitors (ICIs).
• Undergone major organ surgery within 4 weeks prior to the first dose of the study drug.

Other illness

• Combined small cell lung cancer or any transformed small cell lung cancer.
• History of other malignancies within 5 years prior to the first dose of the study drug.
• Severe cardiovascular or cerebrovascular diseases.
• Malignant pleural effusion or malignant pericardial effusion.
• History of immunodeficiency.
• Active, known, or suspected autoimmune disease, or a history of autoimmune disease.

Other

• Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.

• Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
• Aged 18 to 75 years (inclusive), of any gender.
• Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
• ECOG performance status score of 0 or 1.
• Estimated survival time of more than 3 months.
• Have adequate bone marrow and organ function.
• Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.