locally advanced or metastatic NSCLC (non-resistant rare EGFR mutations only, including L861Q, G719X, and/or S768I)
Conditions
Interventions
Experiment group:Oral SZMD4-mal capsule
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years; (2) Patients with locally advanced or metastatic NSCLC confirmed by histopathology and / or cytology; (3) The patient's EGFR has one or more of L861Q, G719X, and S768I mutations, and does not have T790M mutation, exon 19 deletion mutation, exon 20 insertion mutation, and L858R mutation; (4) ECOG physical strength score is 0, 1, or 2 points; (5) The expected survival time is> 3 months; (6) According to RECIST version 1.1, there is at least one evaluable tumor lesion; (7) Have sufficient blood system function, liver function, kidney function and coagulation function: Absolute neutrophil count >=1.5x10^9/L, platelet count >=90x10^9/L, hemoglobin >=90g/L; Total bilirubin =60mL/min (using Cockcroft-Gault method); International standardized ratio (INR) <=1.5; (8) Fertile qualified patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and at least 90 days after the last dose; female patients of childbearing age within 7 days before enrollment Blood human chorionic gonadotropin (HCG) pregnancy test must be negative; male patients cannot be sperm donated within 90 days after the first dose to the last dose; (9) All patients must be informed of the study before commencing any of the tests prescribed in this trial and voluntarily sign a written informed consent (ICF) approved by the ethics committee.
Exclusion criteria
Exclusion criteria: (1) Before receiving any epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) antitumor therapy. (2) Patients who have previously received systemic anti-tumor treatment such as chemotherapy and anti-angiogenesis need an elution period of 4 weeks or more; those who have previously received immunotherapy such as anti-PD-1 / PD-L1 and have not developed immune pneumonia Patients require an elution period of 4 weeks or more; patients who have previously received radiotherapy for non-target lesions for the purpose of relieving symptoms and anti-tumor proprietary Chinese medicines require an elution period of 2 weeks or more; (3) Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before enrollment; (4) At the time of screening, the adverse reactions (ADR) of any previous treatment have not yet returned to the CTCAE 5.0 grade evaluation =grade 3), malabsorption syndrome, or any other condition affecting gastrointestinal absorption (eg peptic ulcer, Obstruction, irritable bowel syndrome, Crohn's disease, gastroesophageal reflux disease, etc.); (6) Immune deficiency, including but not limited to positive detection of human immunodeficiency virus (HIV) antibodies (enzyme-linked immunoassay or Western blot method), active rheumatic immune disease; (7) There are unstable central nervous system metastases or meningeal metastases with clinical symptoms, or there is other evidence that the central nervous system metastases or meningeal metastases have not been controlled, and the investigator judges that they are not suitable for enrollment; the clinical symptoms are suspected of the presence of brain Or patients with meningeal lesions should be excluded by computed tomography / magnetic resonance imaging (CT / MRI); (8) History of severe bullous or exfoliative skin disease (CTCAE 5.0 grade evaluationrating >=grade 3); (9) During the screening, there are uncontrolled active infections [such as syphilis, HIV, hepatitis B virus (HBsAg positive, HBV-DNA> 1000cps / ml and AST / ALT> 2.0xULN) or hepatitis C virus (HCV) infection; (10) Have a history of severe cardiovascular disease [New York Heart Association (NYHA) cardiac function grade 3 or 4], including but not limited to ventricular arrhythmias requiring clinical intervention; within 6 months before enrollment Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 and above cardiovascular events; NYHA cardiac function >=grade 2 or left ventricular ejection fraction (LVEF) =grade 3), which is judged unsuitable for clinical trials by the investigator; (12) Participated in other clinical trials within 4 weeks before enrollment; (13) Known alcohol or drug dependence; (14) Patients with mental disorders or researchers believe that poor adherence is not suitable to participate in the study; (15) Women during pregnancy or lactation; (16) Known allergies to the active ingredients or excipients of the test drug; (17) Long-term use of adrenal steroids is required (equivalent to a daily dose of prednisolone >=20mg, see Appendix IV for the dose conversion table); (18) Have suffered from other malignant tumors in the past 5 years or at the same time (except for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;TTR;TTP;OS;1-year progression-free survival;1-year survival rate; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai Pulmonary Hospital
Outcome results
None listed