Randomized, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.
• Voluntarily participate in the study and signed the Informed Consent Form (ICF).
• Be willing to and able to participate in the trial and comply with the follow up procedures;
• Male or female, aged 18-75 years.
• Expected survival ≥ 3 months.
• ECOG PS score 0 or 1.
• Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment.
• No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC.
• Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function.
• Female participants must be postmenopausal, surgically sterilized, or of childbearing potential with a negative blood pregnancy test within 7 days before the first dose. Female participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate oocytes or breastfeed during this period. Male participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate sperm during this period.
⁃ At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria.
⁃ A PD-L1 expression test report that meets the requirements must be provided before enrollment.