Bevacizumab, Brain Metastases, Non Squamous Non-small Cell Lung Cancer
Conditions
Brief summary
This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. The safety is evaluated as well.
Interventions
pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks.
DRUGBevacizumab and Pemetrexed/platinum
bevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (Patients with NSCLC who are newly diagnosed or treated with brain metastases who are asymptomatic or whose intracranial hypertension symptoms are relieved after dehydration treatment, and whose baseline examinations show EGFR wild type (tissue specimen or blood specimen) and ALK negative (tissue specimen); 2. Patients with MRI-confirmed brain metastasis and ≥3 brain lesions; or patients with 1-2 brain lesions but not suitable for local treatment or refusing local treatment. At least one of the brain lesions must be \>5 mm in diameter. 3. Age 18-75 years old; 4. Physical condition ECOG score (PS) 0-1; 5. The patient's major organ functions are normal, that is, they meet the following criteria: white blood cells count ≥ 4.0x109/L, neutrophil cells count ≥1.5x109/L, hemoglobin ≥100g/L, serum bilirubin ≤1.5 times the upper limit of normal, transaminase ≤2.5 times the upper limit of normal, if there is liver metastasis, less than 5 times the upper limit of normal; serum creatinine is less than 1.5 times the upper limit of normal, or creatinine clearance is greater than 50ml/min and urine protein is \<2+. Patients with baseline urine protein ≥2+ should collect 24-hour urine and prove that the 24-hour urine protein quantitative test is ≤1g. 6. Expected survival time is greater than 12 weeks; 7. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result must be negative, and they must be willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug or have undergone surgical sterilization; 8. Ability to comply with study and follow-up procedures; 9. The patient understands and voluntarily signs the written informed consent.
Exclusion criteria
Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare iPFS(intracranial progression free survival) in two arms | 3 Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate(CR&PR) | 3 years | — |
| safety | 1-year | adverse events (AEs) were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). |
Other
| Measure | Time frame |
|---|---|
| PFS: progress free survival | 3 years |
| OS: overall survival | 3 years |
Countries
China
Outcome results
None listed