the purpose of this study is to evaluate the efficacy and safety of high-dose,pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors)
To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months
Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity
Hefei, Anhui, China
RECRUITINGefficacy and safety
To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days) Radiologically measurable disease by RECIST v1.1 criteria: 1. At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 2. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers
Time frame: 1 year
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