Clinical Trial Details
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NCT01951482 : Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain
metastases by pathologic histology or cytology

2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab)
after diagnosed brain metastases

3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm
by brain MRI

4. Adult patients (= 18 years and =75 years). ECOG Performance Status 0 or 1 Life
expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count
(ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of
normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN
in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to
Cockcroft-gault formula).

5. Patients should be contraceptive during the period of the trial

Exclusion Criteria:

1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a
predominant squamous component.

2. History of haemoptysis

3. Evidence of tumour invading major blood vessels on imaging.

4. Patient was received irradiation of brain. Patient with meningeal metastases were
confirmed by MRI or cytology test of cerebrospinal fluid.

5. Previous radiotherapy.

6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6
months prior to study start or history of serious bleeding complications.

7. Major surgical procedures within 4 weeks prior to study entry.

8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to
the first bevacizumab infusion.

9. Non-healing wound, active peptic ulcer or bone fracture.

10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months of enrollment
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