non-small cell lung cancer
Conditions
Interventions
Non-small cell lung cancer patient group:None
Sponsors
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. All with molecularly pathologically confirmed EGFR mutation-positive non-small cell lung cancer (which includes non-small cell lung cancer with unspecified pathologic staging); 3. Patients staged at stage IV according to the AJCC 8th edition; 4. Patients with progression to TKI; 5. Patients with a comprehensive diagnosis consistent with slow progression/localized progression; 6. Patients with slow progression/localized progression followed by oral ameptinib plus dosage of combination radiation therapy; 7) Expected survival time >=12 weeks; 8) Women of childbearing potential must have a negative serum test within 7 days of the first dose and a negative result. patients; 7. Expected survival >= 12 weeks; 8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose. Women of childbearing potential and men of childbearing potential must agree to use contraception from the time they sign the informed consent form until 24 weeks after the last dose of study drug; 9. Laboratory test values meet the following conditions: (1) Blood count (not transfused or corrected with hematopoietic stimulating factor (HSF) type drugs in the 14 days prior to screening): white blood cell (WBC) >= 3.0 × 10^9 /L. 3.0 × 10^9 /L; absolute neutrophil count (ANC) >= 1.5 × 10^9 /L; platelet (PLT) >= 100 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL; (2) Liver function: no liver metastases. (2) Liver function: no liver metastasis; study participants with aspartate transferase (AST) = 100 × 10^9L; hemoglobin level (hemoglobin, HGB) >= 9.0 g/dL; (2) Liver function: no liver metastasis; (3) Liver function: no liver metastasis; (4) Liver function: no liver metastasis total bilirubin (TBIL) =50 mL/minute; (4) Coagulation (4) Coagulation function: international normalized ratio (INR) <=1.5 x ULN, activated partial thromboplastin time (APTT) <=1.5 x ULN (only for patients not currently on anticoagulation) (only for patients not currently on anticoagulation therapy, and patients currently on anticoagulation therapy should receive a stable dose of anticoagulant);
Exclusion criteria
Exclusion criteria: 1. NSCLC EGFR driver gene negative. Cytologically or pathologically confirmed mixed SCLC, NSCLC, large cell neuroendocrine tumors and sarcomas; 2. Currently enrolled in an interventional clinical study treatment or have received another investigational drug within 4 weeks prior to the first dose; 3. Metastases with blurred borders that cannot be identified; 4. Those diagnosed with respiratory failure after pulmonary function and arterial blood gas analysis; 5. Patients and family members refusing radiotherapy to the primary and metastatic foci after communication; 6. Patients with severe systemic infections, or with other serious diseases; 7. Patients with known allergy or intolerance to TKI or its excipients; 8. Patients who, in the judgement of the investigator, are not suitable for participation in this study. 3. Grouping of study participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Duration of Response;Disease Control Rate;Adverse Events;Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactYingying Zhang
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Outcome results
None listed