Lung Cancer
Conditions
Interventions
treatment group:low-dose alfaatinib combined with bevacizumab and pemetrexed
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Life expectancy was more than 3 months; 3. At least one measurable lesion other than cranial brain was confirmed according to RECIST 1.1; 4. Patients with stage IV non-squamous cell NSCLC confirmed by histopathology according to the 8th edition of Lung cancer staging relies on the TNM system designed jointly by the UICC (Union Internationale Against Cancer) and the AJCC (American Joint Committee on Cancer); 5. The ECOG physical score was 0-1; 6. Have not received any systemic anti-tumor therapy for advanced diseases. If the patient has received platinum-containing adjuvant chemotherapy or neoadjuvant chemotherapy before, and the disease progresses to stage IV more than 6 months after the end of the last treatment, he/she may participate in this clinical study; 7. Gene test from tumor tissues confirmed EGFR mutation positive (including 19del, L858R, G719A, G719C, G719S, L861Q); 8. No brain metastasis, or accompanied by asymptomatic brain metastasis, or symptomatic brain metastasis after treatment which change to stable; 9. Adequate hematological function: neutrophil absolute count >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L exclusion, hemoglobin >= 90 g/L; 10. Adequate liver function: all patients whose total bilirubin level is = 50 mL/min (Cockcroft-Gault formula); 12. Adequate coagulation function: international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times the normal upper limit. If the patient is receiving anticoagulant therapy, as long as INR/PT is within the prescribed range of anticoagulant drugs; 13. Female patients should use effective contraception for at least 180 days after discontinuing treatment. Women of reproductive age were confirmed to have negative urine pregnancy tests or serum pregnancy tests within 3 days prior to the first study drug administration; 14. Patient understand and sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Hisologically squamous cell or mixed NSCLC containing squamous cell morphology; 2. Mixed lung cancer with small cell carcinoma, neuroendocrine carcinoma and sarcoma components should not be included; 3. Patients with non-sensitive EGFR mutation or no EGFR mutation; 4. Patients with meningioma, meningioma or unstable brain metastases; 5. Patients who have had any arterial thrombosis, embolism, ischemic or hemorrhagic disease in the past 6 months and whose condition does not improve after corresponding treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident, etc.; 6. Haemoptysis in the past 3 months, blood loss was defined as bright red blood greater than or equal to 2.5 mL; 7. Other malignant tumors diagnosed within the last 5 years, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical excised carcinoma in situ; 8. Previous treatment with chemotherapy or EGFR-TKIS; those who received adjuvant or neoadjuvant therapy and the time from the last treatment to recurrence was less than 6 months; 9. Patients with proven allergy to low-dose afatinib, bevacizumab, pemetrexed or their excipients or those who are contraintiated; 10. Patients with NSCLC who did not receive chemotherapy or were estimated to be intolerant to chemotherapy; 11. Positive baseline pregnancy test for pregnant, lactating or fertile women; 12. Female patients of childbearing age or male patients with family planning who are unwilling to use effective contraceptive measures during the entire trial period and 6 months after the trial; 13. Anything that interferes with the clinical trial, interferes with the full participation of the subjects, or is not in the best interests of the subjects according to the investigator; 14. Patients with grade 2 or above hypertension before treatment and no improvement or instability after antihypertensive drug therapy; patients with hypertensive crisis or hypertensive encephalopathy; 15. Patients with nephrotic syndrome or pre-treatment proteinuria >= 2+ or above, and no improvement or instability after treatment; 16. Surgical treatment was performed within 60 days; 17. A history of gastrointestinal perforation in the past 6 months; 18. Previous history of severe cerebral disease, especially grade III/IV leukoencephalopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR;Time to response, TTR;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Jie
Shandong Cancer Hospital
Outcome results
None listed