A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination with Osimertinib Versus Osimertinib Alone As First-Line Treatment for Patients with Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
• Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender.
• Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy.
• No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
• Histologically or cytologically confirmed EGFR-sensitive mutations.
• Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
• At least one target lesion assessed by the investigator based on RECIST v1.1.
• ECOG performance status score of 0 or 1 within 7 days prior to randomization.
• Life expectancy ≥ 12 weeks.
• Adequate organ and bone marrow function.