third-line treatment of gefitinib in nsclc patients

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the disease control rate (dcr) of gefitinib as third-line retreatment in stage iiib/iv nsclc with egfr 19del/l858r positive mutation patients who had benefited from first-line gefitinib treatment with egfr 19del/l858r positive mutation and tumor progression after the second-line chemotherapy

* primary study objective: to evaluate the disease control rate (dcr) of gefitinib as third-line retreatment in stage iiib/iv nsclc with egfr 19del/l858r positive mutation patients who had benefited from first-line gefitinib treatment with egfr 19del/l858r positive mutation and tumor progression after the second-line chemotherapy * secondary study objectives: to evaluate objective response rate (orr), progressive-free survival (pfs), overall survival(os) and quality of life (qol) of gefitinib as third-line retreatment in nsclc patients to evaluate the safety of gefitinib as third-line treatment in nsclc patients * exploratory analyses: to dynamically monitor egfr mutation status and explore the relationship with clinical outcome

Eligibility criteria:
inclusion criteria: 1. the subject or legal guardian could understand and sign informed consent form. 2. male or female aged 18 years or older; 3. subjects were diagnosed with stage iiib or iv nsclc before starting the first dose of gefitinib third-line treatment; 4. egfr exon 19 deletion or exon 21 l858r substitution mutation confirmed; 5. ecog performance status 0-2; 6. life expectancy of at least 12 weeks or longer; 7. has at least one measureable lesion by recist 1.1; 8. nsclc of enrolled subjects previously progressed after first-line gefitinib treatment (pfs ≥ 6 months) and progressed again after second-line chemotherapy (not limited for chemotherapy regimen, ≥ 4 cycles of chemotherapy). investigator considers adopting third-line gefitinib retreatment; 9. criteria for laboratory examinations: * total bilirubin (tb) ≤ 1.5 times upper limit of normal * aspartate aminotransferase(ast), alanine aminotransferase (alt) ≤2 times upper limit of normal; for subjects with hepatic metastasis, ast,alt≤ 5 times upper limit of normal * creatinine clearance≥45ml/min exclusion criteria: 1. known severe hypersensitivity to gefitinib or any ingredients of the product; 2. patients with prior exposure to agents directed at the egfr axis except gefitinib (e.g. erlotinib, cetuximab, trastuzumab) ; 3. pre-existing interstitial lung disease or pulmonary fibrosis evidenced by ct scan at baseline; 4. neutrophil count \<1.0×109/l or platelet count \<50×109/l; 5. severe infection, uncontrolled systemic disease (e.g cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc); 6. pregnancy or breast-feeding; 7. women of childbearing age refuse to take adequate contraception measures during gefitinib treatment 8. subjects with other malignant tumors combined; 9. known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication; 10. subjects are unable to take medications orally or have digestive malabsorption; 11. investigators consider subjects should not be involved in the study.