A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer
This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation
• ≥Age 18, gender is not limited;
• Locally advanced or metastatic NSCLC confirmed by pathology;
• Patients who have been genetically tested to carry EGFR sensitive mutations;
• Blood/Tissue samples must be provided for testing;
• Must have a minimum life expectancy of \>= 3 months;
• At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.
• Physical Status (ECOG PS) score was 0-1;
• Have full organ function;
• Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
• Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.