About this trial
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
Eligibility criteria
Qualifiers
≥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;
Disqualifiers
Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
Have previously received more than two EGFR-TKI inhibitors for part A;
Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.
Trial design
Treatments tested in this trial
- Osimertinib (Tagrisso®)
- WSD0922-FU