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

Prior treatment

• 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 (including Chinese patent medicine) 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.
• 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.
• 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.
• Previously received solid organ transplantation or hematopoietic stem cell transplantation.
• Known hypersensitivity to the active ingredients or excipients of the investigational product.

Other illness

• Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
• 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.
• Mental disorders or poor compliance.
• Have any other primary malignant tumors within 3 years (except some low- risk cancers).

Lab values

• Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.

Other

• Active central nervous system metastases
• Females who are pregnant or breastfeeding.

• Age 18 years old and above, male or female.
• Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy.
• Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes..
• At least one measurable lesion.
• ECOG score of 0, 1, or 2.
• A minimum life expectancy of \> 3 months.
• Adequate bone marrow reserve, hepatic, renal and coagulation function.
• Willingness of all subjects of childbearing potential to use acceptable methods of birth control.