lung cancer
Conditions
Interventions
Experimental group: befotertinib 75mg QD
Icotinib 125mg TID
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily enrolled in this study and signed an informed consent form, demonstrated good compliance, and cooperated with follow-up. 2. Age: =18 years old. 3. Histopathologically or cytologically confirmed non-small cell lung cancer. 4. Genetic testing of tissue, blood, pleural effusion, or pericardial effusion revealed EGFR mutation (19del or EGFR L858R). 5. No previous treatment. 6. ECOG performance status: 0-2. 7. Measurable target lesions. 8. No brain metastases or asymptomatic brain metastases after treatment. 9. Expected survival time >3 months. 10. Normal function of major organs, meeting the following criteria: 1) Hematological examination criteria must meet (no blood transfusion or blood products received in the past 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction): - Hemoglobin (HB) = 90 g/L - Absolute neutrophil count (ANC) = 1.5×10^9/L (1500/m3) - Platelet count (PLT) = 80×10^9/L 2) Biochemical examination criteria need to meet the following standards: - Total bilirubin (TBiL) = 1.5ULN; for subjects with liver metastases or evidence of or suspected Gilbert's disease, TbiL = 3ULN - ALT and AST = 2.5ULN; for subjects with liver metastases, ALT and AST = 5ULN - Serum creatinine (Cr) = 1.5ULN or estimated glomerular filtration rate (CrCl) = 50 ml/min (Cockcroft-Gault formula: CrCL (mL/min)=[(140-age) * body weight (kg * F)] / (SCr (mg/dL) * 72). In this formula, F=1 for males, F=0.85 for females, SCr=serum creatinine). 11. Doppler echocardiography evaluation: Left ventricular ejection fraction (LVEF) = lower limit of normal (50%). 12. Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with negative results, and be willing to use appropriate contraception during the trial period and for 8 weeks after the last administration of the investigational drug. For males, they must agree to use appropriate contraception during the trial period and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer and advanced non-small cell lung cancer without EGFR mutation. 2. Local radiotherapy of chest lesion is required. 3. Medical history and comorbidities: 1) Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or those with diseases of the brain or leptomeninges detected by screening imaging CT or MRI (patients with brain metastases who have completed treatment and have stable symptoms can be included, but confirmation of no symptoms of cerebral hemorrhage is required through cranial MRI, CT, or venography); 2) Patients currently participating in other clinical studies (excluding non-interventional studies) or within less than 4 weeks since the end of the previous clinical study treatment; 3) Patients who have received chemotherapy, radiotherapy, or other investigational anticancer therapies (excluding bisphosphonate drugs) in the 4 weeks prior to the first dose of the investigational drug. Patients who have previously received local radiotherapy can be included if they meet the following conditions: it has been more than 4 weeks since the end of radiotherapy (except for brain radiotherapy, which requires more than 2 weeks); and the targeted lesions selected for this study are not within the radiation therapy area, or the targeted lesion is located within the radiation therapy area but progression has been confirmed; 4) Occurrence of or currently suffering from other malignancies within the past 2 years, excluding cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (noninvasive tumors), Tis (carcinoma in situ), and T1 (tumor invasive basement membrane)]; 5) Active, known, or suspected autoimmune diseases, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, HIV positive history, or acquired immune deficiency syndrome (AIDS); 6) Active or previously documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis); 7) Patients whose adverse reactions related to previous systemic anticancer treatment (excluding alopecia) have not recovered to NCI-CTCAE = Grade 1; 8) Coagulation dysfunction (INR > 1.5, prothrombin time (PT) > ULN + 4 seconds, or APTT > 1.5 ULN), with bleeding tendencies or undergoing thrombolysis or anticoagulation therapy; Note: In the case of a history of coagulation disorder with international normalized ratio (INR) = 1.5, the use of low-dose heparin (daily dose of 6,000-12,000 IU for adults) or low-dose aspirin (daily dose = 100 mg) is allowed for prophylactic purposes; 9) Clinically significant hemoptysis within 3 months before enrollment (daily hemoptysis > half a spoon) or significant clinically meaningful bleeding symptoms or bleeding tendencies within 4 weeks before randomization, such as gastrointestinal bleeding, bleeding gastric ulcer (including gastric and intestinal perforation and/or fistula; however, patients with gastric or intestinal perforation or fistula that has been surgically removed can be included), baseline stool occult blood ++ or above, unhealed wounds, ulcers or fractures, etc.; 10) Renal dysfunction: urine routine indicating urine protein = ++ or confirmed 24-hour urine protein > 1.0g; 11) Poorly controlled blood pressure after medication (systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg); 12) Severe cardiovascular diseases: grade II or above myocardial ischemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival;Security; | — |
Countries
China
Contacts
Public ContactZhongdian Sheng
Tianjin Medical University General Hospital
Outcome results
None listed