A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
• Age 18 to 75 years old (inclusive), Female or male
• Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
• Previously treated by EGFR-TKI；
• At least one measurable tumor lesion according to RECIST v1.1
• ECOG performance score of 0-1;
• Expected survival time ≥ 12 weeks;
• Adequate bone marrow and organ function
• Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.