Phase
Condition
Neoplasm Metastasis
Non-small Cell Lung Cancer
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who was confirmed non-small cell lung cancer (NSCLC) by histology orcytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn'treceive any treatment after diagnosed with brain metastasis) by MRI, couldn't receiveoperation or stereotactic radiosurgery(SRS).
Appraisable disease, that is there must be at least one lesion with the longestdiameter>10mm in brain (by brain MRI).
Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group(ECOG)performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl,absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; totalbilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase(ALT) andaspartate aminotransferase(AST)< 1.5x ULN in the absence of liver metastases, or < 5xULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated accordingto Cockcroft-gault formula).
Patients should be contraceptive during the period of the trial.
Exclusion
Exclusion Criteria:
Patients who had received brain radiotherapy or EGFR-TKI before.
Patients who can't receive WBRT.
Uncontrolled intracranial hypertension after steroid or dehydration therapy.
Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wortwhich will interfere with the metabolism of TKI.
Patients with interstitial lung disease, significant ocular disease, or seriousuncontrolled systematic disease.
Patients who can't take oral tablets, with active peptic ulcer diseases.
Pregnancy or breast-feeding women.
Study Design
Connect with a study center
Sun Yat-sen University of cancer center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting

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