Gefitinib With or Without Pemetrexed/Cisplatin in Brain Metastases From Non-small Cell Lung Cancer
Non-small Cell Lung Cancer - Brain Metastases - EGFR Mutation
Conditions: official terms
Brain Neoplasms - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Neoplasm Metastasis
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Gefitinib and Pemetrexed/cisplatin Type: Drug
Name: Gefitinib mono-therapy Type: Drug
Overall Status
This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combinating with Pemetrexed/cisplatin 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology

2. Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) 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 until 8 weeks after the last administration of icotinib.

6. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

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

2. Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.

3. Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.

4. Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .

5. 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).

6. 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.

7. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

8. The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment
Sun Yat-sen University of Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: li-kun Chen, doctor - 13798019964 -
Start Date
June 2013
Completion Date
June 2017
Sun Yat-sen University
Sun Yat-sen University
Record processing date processed this data on July 28, 2015 page