A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Eligibility Criteria

• 1. Age 18-75 years old, male or female
• 2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
• 3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
• 4. At least one measurable lesion
• 5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
• 6. A minimum life expectancy of \> 3 months
• 7. Adequate bone marrow reserve, hepatic, renal, and coagulation function
• 1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)
• 2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment
• 3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment
• 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
• 5. Any unresolved toxicities from prior therapy greater than Grade 1, at the time of screening except for alopecia
• 6. Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
• 7. Active central nervous system metastases
• 8. Any active infection which has not been controlled at screening.