A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
• Able and willing to provide a written informed consent
• 18-75 years old (inclusive of both ends)
• ECOG score of 0 or 1.
• Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
• Subjects with central laboratory- confirmed functional HER2 mutations
• No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
• Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
• Protocol-defined adequate organ function including cardiac, renal, hepatic function