non-small cell lung cancer
Conditions
Interventions
Case series:Aumolertinib 110 mg orally, once a day
bevacizumab 15 mg/kg intravenous drip (on the first day of each cycle), every 21 days as a cycle.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with non-squamous non-small cell lung cancer diagnosed by histology or pathology, including patients with newly diagnosed stage IV or recurrence and metastasis after surgery. For patients with recurrence and metastasis after surgery, the time from the last postoperative adjuvant chemotherapy should be >=4 weeks; radiotherapy: the time from the last chest radiotherapy should be more than 12 weeks; the time from other parts of the radiotherapy should be more than 2 weeks; the time from the last operation more than 4 weeks (Except for thoracic or pericardial drainage); thoracic or pericardial drainage: more than 2 weeks or longer from the date of drainage; 2.Patients with malignant pleural effusion or pericardial effusion (in principle, cytological examination should be performed, but even if there is no malignant cytological examination, patients with imaging and clinical evidence of malignant pleural effusion or malignant pericardial effusion can also be used According to this standard, it is deemed qualified); 3.EGFR mutation positive; 4.Patients can take drugs orally; 5.Have one or more measurable lesions in accordance with the RECIST 1.1 standard; 6.ECOG score 0~2 points; 7.Aged 18 to 75 years; 8.The main organs are functioning normally, that is, they meet the following standards: (1)The standard of blood routine examination should meet: 1)ANC>=1.5x10^9/L; 2)PLT>=100x10^9/L; 3)Hb>=100g/L; (No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days) (2)The biochemical inspection must meet the following standards: 1)TBIL=50ml/min (Cockcroft-Gault formula). 9.The estimated survival time exceeds 3 months; 10.Women of childbearing age must have taken reliable contraceptive measures or undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last trial drug administration . For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 11.Subjects voluntarily join the study, and sign an informed consent form, have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone pleurodesis due to pleural effusion (pleural drainage is allowed); 2.Combined with lung diseases, such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonia, drug-induced pneumonia, etc.; 3.Hemoptysis caused by lung tumors, a hemoptysis volume >=2.5ml, or current or past history of blood sputum, meet the following conditions: continuous blood sputum (lasting 1 week or longer); long-term oral hemostatic drugs are required (for example: Recurrence after improvement of oral hemostatic drugs requires repeated use of oral hemostatic drugs); blood sputum requires injection of hemostatic drugs; 4.The patient has cavitary lung disease, or tumor invades large blood vessels; 5.Accompanied by infectious diseases that require intravenous antibiotics or antifungal drugs; 6.Patients with corneal ulcers; 7.Patients with prolonged OTc interval of any of the following: (1)Average corrected QT interval at rest> 470 milliseconds (Fridericias correction: QTC); (2)Clinically important abnormalities (such as complete left bundle branch block, third degree heart block, second degree heart block), or abnormal resting ECG waveform (such as complete left bundle branch block, third degree Heart block, II degree heart block); (3)Any factor that increases the risk of QTc prolongation or arrhythmia (such as heart failure, hypokalemia, congenital prolonged QT syndrome, family history of long QT syndrome, or sudden death of unexplained first-degree relatives aged 40 or younger, or any known cause Concomitant drugs that prolong the QT interval); 8.Pregnant and lactating women; 9.Symptomatic brain metastases; 10.Failure to control multiple primary malignant tumors; 11.Uncontrolled diabetes; 12.Combined with serious complications: such as uncontrollable heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.; 13.Researchers consider serious or uncontrollable systemic diseases: (for example, uncontrollable hypertension, active bleeding diathesis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, or other peoples opinion Active infections that hinder participation in research or obstruct compliance with protocols); 14.Patients with intractable nausea and vomiting, chronic gastrointestinal disease or inability to swallow drugs, or a history of gastrointestinal resection or other operations that may significantly affect the absorption of Ametinib; 15.Patients with unhealed wounds; 16.The investigator judged that it was not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;overall survival;the incidence rate of no need for chest/pericardial drainage;overall response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactNing Jie
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed