Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

Exclusion Criteria18

• Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
• Any systemic anti-tumor therapy such as chemotherapy, immunotherapy and radiation therapy used within 4 weeks prior to enrollment; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for tumor within 2 weeks prior to enrollment.
• Use or intake of drugs or foods containing potent inhibitor or inducer of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever was the longer, prior to enrollment.
• Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment.
• Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia.
• Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
• Active central nervous system metastases
• Previous or current interstitial lung disease, radiation pneumonitis which requires hormone therapy, or drug-related pneumonia, idiopathic interstitial pulmonary fibrosis identified in a baseline CT scan; uncontrolled massive pleural or pericardial effusion.
• Any active infection which has not been controlled at screening.
• Any serious cardiovascular disease.
• History of other serious systemic disease not suitable for clinical trial.
• Participation in other interventional clinical trial 4 weeks prior to enrollment or within 5 half-lives from the last dose of investigational product (whichever is longer).
• Known alcohol or drug dependence.
• Mental disorders or poor compliance.
• Previously received solid organ transplantation or hematopoietic stem cell transplantation.
• Females who are pregnant or breastfeeding.
• Known hypersensitivity to the active ingredients or excipients of the investigational product.
• Have any other primary malignant tumors within 3 years (except some low- risk cancers).