EGFR-positive mutations in advanced metastatic non-small cell lung cancer
Conditions
Interventions
test group:The first day to take domestic gefitinib 250mg, followed by 250mg daily taking gefitinib
Control group:The first day to take imported gefitinib 250mg, followed by 250mg daily taking gefitinib
Sponsors
Jiangsu Provincial Cancer Hospital/Huazhong University of Science Tongji Hospital, Tongji Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged =18 years old; ECOG PS score 0 ~ 1; expected survival period of more than 3 months; 2. histologically or cytologically diagnosed patients with locally advanced or metastatic non-small cell lung cancer, can not accept radical; Surgery or radiotherapy; patients with measurable lesions (according to RECIST criteria); 3. to provide a testable specimen (tissue or cancerous pleural effusion) before the group to carry out genotyping, test results show EGFR-positive exon 19 deletion or exon 21 (L858R) mutation; 4) major organ function within 7 days prior to treatment, meeting the following criteria: (1) blood routine examination criteria (14 days without blood transfusion): hemoglobin (HB) = 90g/L; neutrophil absolute (ANC) = 1.5×10^9/L; platelet (PLT) =80×10^9/L; (2) biochemical tests to meet the following criteria: total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 ULN, Liver metastases, ALT and AST = 5 ULN; serum creatinine (Cr) = 1.5 ULN or creatinine clearance (CCr) = 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = normal low (50%). 5. Women of childbearing age should agree that contraceptive measures must be used within the study period and within six months of the end of the study (eg, intrauterine Fertility, contraceptive or condom); serum or urine pregnancy test was negative within 7 days prior to enrollment and must be non-Breast-feeding patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 6. patients voluntarily participate in this study, signed informed consent.
Exclusion criteria
Exclusion criteria: 1) patients who have previously used EGFR-TKI drugs; 2) small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 3) central type, with empty lung squamous cell carcinoma, or with non-small cell lung cancer with hemoptysis (> 50 ml / day) 4) 5 years or present at the same time with other malignant tumors, cured cervical carcinoma in situ, non-melanoma Of skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltration membrane)]; 5) within 4 weeks before randomization or during the study of the drug plan for systemic anti-tumor therapy, including cytotoxic therapy, Signal transduction inhibitors, immunotherapy (or the use of mitomycin C within 6 weeks of treatment with the test drug); 6) patients with symptomatic or unstable brain metastases; 7) patients with any severe and / or uncontrolled disease, including: A) cirrhosis, acute or active hepatitis; B) history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, Or a history of organ transplantation; C) patients with seizures and who need treatment; 8) active or uncontrollable serious infection (=CTC AE Level 2 infection); 9) with a history of mental illness and can not quit or have mental disorders; 10) participated in other anti-tumor drug clinical trials within four weeks; 11) According to the judge's judgment, there is an impact on the absorption of oral drugs or serious harm to the safety of patients is not suitable for participation in this item The situation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR=CR+ PR;DCR=CR+PR+ SD;Quality of life score;Evaluation of biomarkers;Safety indicators; | — |
Countries
China
Contacts
Public ContactFeng jifeng/Chen Yuan
Huazhong University of Science Tongji Hospital, Tongji Medical College
Outcome results
None listed