Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations.
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Male or female, ≥18 years old and ≤75years old; Non-squamous non-small cell lung cancer (NSCLC) confirmed by pathology (including histology or cytology); ③ EGFR mutation positive (exon 19 deletion or exon 21 L858R mutation); (4) ≥3 intracranial metastases, asymptomatic brain metastases; (5) Never received antitumor therapy before; There was at least 1 measurable intracranial and extracranial lesion in CT/MRI according to RECIST1.1 criteria. ⑦ Predicted survival ≥3 months; ⑧ ECOG score 0-1; ⑨ The main organs (liver, kidney, heart) function normally. ⑩ Sign informed consent forms. Exclusion Criteria: The intracranial metastases were oligometastases; There are symptoms of increased intracranial pressure; (3) Previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) Patients with hypertension and can not be reduced to the normal range after antihypertensive drug treatment, have grade I coronary heart disease, grade I arrhythmia and grade I cardiac insufficiency; Patients with definite tendency to gastrointestinal bleeding; ⑥ with hemoptysis symptoms; ⑦ Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; ⑧ Have a history of psychotropic drug abuse and can not abstain or have mental disorders; ⑨According to the investigator's judgment, Patients who have a serious concomitant disease that endangers the patient's safety or affects the patient's completion of the study, and who have previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function.
Sites / Locations
- The Second Affiliated Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Ametinib combined with bevacizumab
Ametinib 110 mg po qd bevacizumab 15mg/kg ivdrip q3w