A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer

Prior treatment

• Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
• Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
• Severe infections, including but not limited to bacteremia requiring hospitalization and severe pneumonia, were present within 4 weeks prior to the first medication; Within 2 weeks prior to the first medication, there is an active infection with CTCAE ≥ 2 that requires treatment with systemic antibiotics.
• Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment.

Other illness

• History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically significant active pneumonia at screening; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may participate in this study).
• History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
• Known to have alcohol or drug dependence; Individuals with mental disorders or poor compliance; Pregnant or lactating women; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make it unsuitable to participate in this clinical study.

Other

• Patients with central nervous system or meningeal metastases.
• Patients diagnosed by researchers with uncontrollable tumor related pain.
• Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.

• Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
• ECOG physical fitness score 0-1 points.
• According to RECIST v1.1, there must be at least one measurable tumor lesion.
• Expected survival time ≥ 12 weeks.
• Having sufficient bone marrow and organ function.
• Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.