Wayshine Biopharm

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

This study is a multicenter, open label, single-arm phase I/II clinical study of WSD0922-FU conducted in China, including Part A (dose escalation and expansion study) and Part B (dose extension). To explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance (Osimertinib, Almonertinib, Furmonertinib, Befotertinib).