Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer

  • days left to enroll
  • participants needed
  • sponsor
    Sun Yat-sen University
Updated on 13 March 2022
lung cancer
neutrophil count
liver metastasis
brain metastases
cancer chemotherapy
whole-brain radiotherapy
stage iv non-small cell lung cancer
lung carcinoma
secondary malignant neoplasm of liver


This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combinating with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Condition Non-small Cell Lung Cancer, Brain Metastases, EGFR Mutation
Treatment Gefitinib and Pemetrexed/cisplatin, Gefitinib mono-therapy, Gefitinib and Pemetrexed/platinum
Clinical Study IdentifierNCT01951469
SponsorSun Yat-sen University
Last Modified on13 March 2022


Yes No Not Sure

Inclusion Criteria

Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology
Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) after diagnosed brain metastases
Patients had at least three metastatic lesions in brain, or patients with 1-2 intracranial lesions who were not suitable for brain radiotherapy, or patients with 1-2 intracranial lesions who refused brain radiotherapy, at least one intracranial lesion with the longest diameter of >5 mm
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)
Patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib
Able to comply with the required protocol and follow-up procedures, and able to receive oral medications

Exclusion Criteria

Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid
Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort
Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody
Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled
Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease
The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment
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