NSCLC
Conditions
Interventions
Group A:Intercalated combination of chemotherapy and icoti
Group B:Chemotherapy followed by icotinib maintenance
Sponsors
The First affiliated Hospital of Guangxi Medical University
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Unreceptable patients with stage IIIB/IV non-small cell lung cancer confirmed by histological or cytological diagnosis. The subjects must have received two cycles of gemcitabine (1000 mg/m2 on days 1 and 8, intravenously) plus platinum (cisplatin 75 mg/m2 on day 1, intravenously) as first line treatment, efficacy evaluated as DCR (CR+PR+SD); 2.Having obtained EGFR gene test, activating mutations in the EGFR gene; 3.Aged 18 to 75 years; 4. Life expectancy of at least 12 weeks; 5.ECOG Performance Status of 0, 1, 2; 6.Patients with at least one measurable lesion meeting RECIST 1.1; 7. Adequate organ function, meeting the following criteria: Bone marrow: absolute neutrophil count (ANC) more than 1.5 times 10*9/L, Platelet count 80 times 10*9/L, Hemoglobin more than 9 g/dL; Hepatic: bilirubin less than 1.5 times the upper limit of normal, ALT and AST less than 2.5 times upper limit of normal (5 times upper limit of normal are acceptable if the liver has tumor involvement); Renal: endogeny CCR more than 60mL/min based on the standard Cockcroft-Gault formula or Serum Creatinine less than 1.25 times the upper limit of normal; 8.Female: Women of childbearing potential must have a urine pregnancy test taken and proven negative within 7 days prior to the treatment and must not be lactating; Male: Must be surgically sterile or compliant with a contraceptive regimen during and for 8 weeks after the treatment; 9.Patient compliance allows adequate follow-up; 10.Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment ,investigational therapy, adjuvant chemotherapy or neoadjuvant chemotherapy (postoperative relapse after 6 months can be enrolled) before administered by GP chemotheraphy; 2.Having local radiotherapy of NSCLC; 3.Concurrent treatment with sodium phenytoin, carbamazepine, rifampin, barbital or Sant Jone grass; 4.No other malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or treated cervical cancer in situ or surgical treatment of localized prostate cancer or surgical removal of ductal carcinoma in situ; 5.Patients with the following one or more conditions:Symptomatic central nervous system (CNS) metastasis or oppression in spinal cord.Interstitial lung disease, drug-induced pneumonia, radiation pneumonia which requires treatment with corticosteroids, active interstitial lung disease evidence on clinical evaluation, pre-existing idiopathic pulmonary fibrosis as evidenced by CT scan at baseline.A great amount of pleural effusion or hydropericardium.Any unstable systemic disorders(including active infection, uncontrollable hypertension, unstable angina pectoris, congestive heart failure, liver and kidney disorder or metabolism disease).Any remarkable eye disorders, especially severe dry eye syndrome, dry kerato-conjunctivitis, serious exposition keratitis or other disease that can cause damage to epithelia of cornea.Patients unable to accept the oral dosing ; need intravenous high nutrition; have received surgery that affects absorption before ; have active peptic ulcer; have chronic diarrhea.Any clinical evidence suggests that moderately severe chronic obstructive pulmonary disease (COPD) (have a history of chronic obstructive pulmonary disease or risk factors, lung function measurement FEV1/FVC less than 70%, FEV1 less than 80% expected value, with or without chronic cough, sputum, dyspnea symptom) and other researchers determine active lung disease. Known hypersensitivity to platinum, gemcitabine, icotinib or any of the excipient. 6.Inability to comply with protocol or study procedures in the opinion of the investigator (management or any other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;safety;Pharmacoeconomics evaluation; | — |
Countries
China
Contacts
Public ContactHu Xiaohua
Outcome results
None listed