Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.

Who cannot join

• Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma; NSCLC non-squamous histological type with EGFR mutation-positive or ALK-positive subjects. Non-squamous subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing, with TPS score <50%; Malignant pleural effusion. If the subject has pleural effusion that can be aspirated during the screening period, at least one pleural puncture is required to confirm the presence of malignant cells; Previous systemic treatment for non-small cell lung cancer (including clinical study medication) has been received. If the subject has previously received traditional Chinese medicine for anti-tumor treatment, the end of the treatment must be separated from the first study medication by a time interval of no less than 2 weeks; Previous thoracic radiotherapy has been received; Participation in other clinical studies within 4 weeks before the first dose or 5 half-lives of the study drug, whichever is shorter; Systemic immune stimulation therapy (including but not limited to interferon or interleukin-2, including immune stimulation agents in clinical trials) within 4 weeks before the first dose; Systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, antineoplastic cytokines) within 2 weeks before the first dose or is expected to be required during the study treatment period. Subjects who have received short-term, low-dose (≤10mg/day prednisone or equivalent dose) systemic immunosuppressive drugs or short-term high-dose systemic immunosuppressive drugs (such as for treatment of contrast agent allergy with glucocorticoids for 48 hours) may be included in the study after obtaining approval from the medical monitor. Subjects who use glucocorticoids (≤10mg/day prednisone or equivalent dose) for treatment of chronic obstructive pulmonary disease, mineralocorticoids for treatment of orthostatic hypotension, and physiological replacement doses of glucocorticoids for treatment of adrenal insufficiency may be included; There are autoimmune diseases. The following conditions are allowed: type I diabetes (blood sugar can be controlled by insulin therapy); hypothyroidism caused by autoimmune thyroiditis that only needs hormone replacement therapy; only vitiligo dermatosis (psoriatic arthritis needs to be excluded); History of other malignancies (except non-small cell lung cancer) within the screening period, excluding cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostatic cancer, ductal carcinoma in situ, hormone replacement therapy for non-metastatic prostate cancer or breast cancer; Known or suspected interstitial pneumonia or other serious lung diseases that may interfere with lung toxicity testing or treatment, including significant respiratory function impairment; Severe cardiovascular diseases such as NYHA classification II or higher, myocardial infarction or cerebrovascular accident (stroke, hemorrhagic stroke) within 3 months before the first dose, unstable arrhythmia or unstable angina within 1 month before the first dose; Significant bleeding symptoms or bleeding tendency within 1 month before the first dose, such as gastrointestinal bleeding, gastric ulcer bleeding, or suffering from thromboangiitis obliterans; Deep venous thrombosis and pulmonary embolism within 3 months before the first dose; HIV positive; Active hepatitis B (HBsAg positive and HBV-DNA test result higher than the upper limit of normal in the local laboratory during screening) or hepatitis C (HCV-Ab positive and HCV-RNA positive during screening); Active tuberculosis infection within 1 year before the first dose; Serious infection within 4 weeks before the first dose, including hospitalization and/or antibiotics treatment for ≥2 weeks for infections such as sepsis, severe pneumonia, etc.; antibiotics treatment for active infections within 2 weeks before the study treatment; Vaccination with live attenuated vaccines within 28 days before the first dose; Major surgery within 28 days before the first dose; Previous or planned allogeneic bone marrow transplantation or solid organ transplantation; History of severe allergic reaction to other monoclonal antibody / fusion protein drugs; Allergic to any component of the investigational product; Pregnant, breastfeeding, or planning to become pregnant during the study period; Subjects with a history of substance abuse, alcoholism, or drug addiction; The researchers believe that any other medical (such as pulmonary, metabolic, endocrine, or neurological diseases, congenital diseases, etc.), psychiatric, or social conditions that may interfere with the rights, safety, health, or ability of the subjects to sign informed consent, collaborate and participate in the study, or interfere with the evaluation of study drugs, interpretation of patient safety, or study results.