SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer

Korábbi kezelés

• Pleural effusion, peritoneal effusion, or pericardial effusion requiring clinical intervention within 2 weeks prior to the first administration of the study drug
• Severe infection occurring within 4 weeks prior to the first study drug administration (including but not limited to bacteremia requiring hospitalization, severe pneumonia, active pulmonary tuberculosis, etc.); active infection requiring systemic antibiotic therapy within 2 weeks prior to the first study drug administration
• Lactating or pregnant females; females of childbearing potential with a positive blood pregnancy test within 7 days before study enrollment; all male and female patients of childbearing potential who decline to use highly effective contraceptive methods throughout the study period and for 6 months after the last drug administration

Más betegség

• History of or current with other malignant tumors (excluding non-melanoma skin cancer, in situ breast cancer, in situ cervical cancer, and superficial bladder cancer that have been effectively controlled within the past 5 years)
• Active leptomeningeal disease or poorly controlled, untreated brain metastases (excluding patients with brain metastases that are well-controlled with local therapy)
• Interstitial lung disease (ILD), drug-induced interstitial pneumonitis, or non-infectious pneumonitis (including radiation pneumonitis, pulmonary fibrosis, acute lung disease requiring steroid therapy), and patients with severe impairment of pulmonary function
• Active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). However, participants with the following conditions are eligible for further screening: well-controlled type 1 diabetes mellitus; well-controlled hypothyroidism requiring only hormone replacement therapy; dermatological diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia); or participants with diseases not expected to relapse in the absence of external triggers
• Peripheral neuropathy of Grade ≥2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
• Known hypersensitivity or anaphylaxis to any study drug, or a history of other severe hypersensitivity reactions
• History of immunodeficiency (including positive human immunodeficiency virus (HIV) test results, other acquired or congenital immunodeficiency diseases); a history of allogeneic stem cell or organ transplantation; other conditions that the investigator deems unsuitable for study participation (e.g., psychiatric disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, etc.)

Laborértékek

• History of severe cardiovascular disease within 6 months prior to the first administration of the study drug, including but not limited to:(1)Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); Fridericia-corrected QT interval (QTcF) \> 480 ms (Fridericia formula: QTcF=QT/RR\^0.33, where RR=60/heart rate);(2)History of myocardial infarction, unstable angina pectoris, angioplasty, or coronary artery bypass graft surgery;(3)Heart failure of New York Heart Association (NYHA) Functional Class Ⅱ or higher; left ventricular ejection fraction (LVEF) \< 50% as detected during screening
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBc) positive, with HBV DNA copy number ≥ 1×10\^4 copies/mL (or ≥ 2000 IU/mL); Hepatitis C virus antibody (anti-HCV) positive, with HCV RNA level exceeding the lower limit of quantification (LLOQ) of the applied analytical method

• Age: ≥18 years old
• Histologically or cytologically confirmed locally advanced or metastatic squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV according to the IASLC 9th Edition TNM Staging System), ineligible for radical surgery and/or radical radiotherapy
• Confirmed negative for driver genes (including EGFR mutation, ALK fusion, ROS1 fusion, etc.)
• Tumor cell PD-L1 expression in tumor tissue ≥1% (TPS ≥1%)
• No prior systemic anti-tumor therapy for Stage IIIB/IIIC and IV NSCLC, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs, Chinese herbal medicines or proprietary Chinese medicines, and other investigational drugs for tumor control
• ECOG PS score 0\~1
• At least one measurable lesion according to the RECIST 1.1 criteria
• Adequate bone marrow and other organ functions:(1)Hematology: No significant signs of hematological disease; absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥90 g/L at screening. For patients with hematological indicators at the critical value who fail to meet the above criteria, the investigator will determine eligibility based on the patient's physical condition. (2)Coagulation function: International Normalized Ratio (INR) ≤1.5 × upper limit of normal (ULN); activated partial thromboplastin time (APTT) ≤1.5 × ULN. (3)Hepatic and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤2.5 × ULN; for patients with hepatic metastasis, both AST and ALT ≤5 × ULN. Total bilirubin (TBiL) ≤1.5 × ULN; for patients with known Gilbert's disease: serum total bilirubin level ≤3 × ULN. Serum creatinine (Cr) ≤1.5 × ULN
• Expected survival ≥3 months
• Able to understand the study details; the patient and/or legal guardian voluntarily consents to participate in the study and signs the informed consent form