Lung cancer
Conditions
Interventions
Experimental group:Almonertinib plus bevacizumab
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) age =18 years and =75 years; 2) life expectancy of more than 3 months; 3) patients with advanced NSCLC who had histologic or cytological confirmation according to the International Association for the study of lung cancer and the American Joint Committee on Classification of Cancer, 8th edition TNM staging classification of lung cancer; 4) Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1; 5) had not received any previous systemic anti-tumor therapy for advanced disease; if had received prior platinum-based adjuvant chemotherapy, neoadjuvant chemotherapy, and disease progression to stage IV, and had occurred > 6 months after the end of the last treatment, were eligible to participate in this clinical study; 6) had a positive EGFR mutation (including 19 DEL, L858R) confirmed by histiocytogenetic testing; 7) CT or MRI confirmed metastases of more than or equal to 2 organs or single organs > GT 3, and brain metastases included symptomatic, asymptomatic, and meningeal metastases 8) haematological adequacy: absolute neutrophil count =1.5 × 10^9 L, platelet count =100 × 10^9 L, and hemoglobin =90 g/L 9) liver adequacy: total bilirubin level =1.5 times the upper limit of normal, aspartate transaminase and Alanine transaminase levels =2.5 times the upper limit of normal 10) renal adequacy: defined as creatinine clearance rate =50 ml/min (Cockcroft-Gault formula) 11) clotting adequacy: international standard ratio (INR) or prothrombin time (PT)=1.5 times the upper limit of normal; If the patient is receiving anticoagulant treatment, INR/PT should be within the range of anticoagulant drugs proposed; 12)Female patients need to use efficient contraception and continue for at least 180 days after discontinuing the trial treatment. And confirm that female patients of childbearing age received negative urine pregnancy test or serum pregnancy test within 3 days before the first study drug administration. 13)The subjects volunteered themselves and signed the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1) squamous cell or mixed NSCLC with squamous cell morphology, 2) mixed NSCLC with small cell carcinoma, neuroendocrine carcinoma or sarcoma, 3) non-sensitive EGFR mutation or no EGFR mutation, 4) unstable patients who had any arterial thrombosis, embolism or ischemic or hemorrhagic disease within 6 months and had no improvement after treatment, such as unstable myocardial infarction, unstable angina pectoris, cerebrovascular accident, 5) hemoptysis within 3 months and the amount of bleeding was defined as bright red blood or 2.5 ml or more, 6) other malignant tumors, not including skin basal-cell carcinoma, skin squamous-cell carcinoma and or carcinoma in situ, were diagnosed within 5 years; 7) prior chemotherapy or EGFR-TKIs therapy, adjuvant or neoadjuvant therapy with a duration of less than 6 months from the last treatment to relapse, 8) proven allergy or contraindication to Amy, bevacizumab, or its adjunct, 9) positive baseline pregnancy test in pregnant, lactating, or fertile women, 10) women of Reproductive Age who were unwilling to use effective contraception throughout the trial period and up to 6 months after the end of the trial, or male patients who had planned to have a child; 11)There is interference with clinical trials, hindering the full participation of subjects, or the researcher believes that it is not in the best interests of the subjects; 12) patients with grade 2 or above hypertension before treatment and no improvement or instability after antihypertensive drug treatment; Patients with hypertensive crisis or hypertensive encephalopathy; 13) patients with nephrotic syndrome or with proteinuria =2 + or above before treatment and no improvement or instability after treatment, 14) Surgical treatment is required within the past 60 days; 15) Have a history of gastrointestinal perforation in the past 6 months; 16) Patients with a history of severe brain disease, especially those with grade III/IV white matter lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Quality of life;Safety;Disease control rate;Durative time of remission;Time for tumor to reach remission; | — |
Countries
China
Contacts
Public ContactHai Yan Liu
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed