Non-Small Cell Lung Cancer(NSCLC)
Conditions
Interventions
Group B:Icotinib 125mg oral, three times a day
gefitinb dummy, 250mg oral, once a day.
Group B:Gefitinb, 250mg oral, once a day, one tablet
Icotinib dummy, 125mg oral, three times a day
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients with locally advanced or metastatic IIIB/IV non-small cell lung cancer who are confirmed by histological or cytological diagnosis, tumor must be in progress; 2. Received at least one chemotherapy drugs, one of these must platinum-based chemotherapy, And at the end of prior chemotherapy treatment is at least four weeks from this registration to participate in this study. The subject must have recovered from any previous chemotherapy toxicity; 3. If they only accept radiation-sensitizing doses of platinum treatment, would not be eligible for selection; 4. To be aged from 18 to 75; 5. Patients with at least one measurable lesion meeting RECIST, and that the lesion had not received irradiation: (1) At least one measurable lesion. Histology and/or cytology diagnosis will be necessary if patients with only one lesion; (2) Lesions can be accurately measured in by the following methods: CT-scan of chest or abdomen or Magnetic resonance imaging (MRI), the 1 dimension as >=20 mm with conventional techniques, or as >=10 mm with spiral computed tomography (CT) scan; 6. ECOG Performance Status of 0, 1, 2; 7. Life expectancy of at least 12 weeks; 8. Adequate organ function, meeting the following: (1) Bone marrow: Absolute neutrophil count (ANC) >=1.5*10^9/L, Platelet count >=90*10^9/L, Hemoglobin >=9g/dL; (2) Hepatic: bilirubin =60mL/min based on the standard Cockcroft-Gault formula or Serum Creatinine <=1.5 times the upper limit of normal; (4) No malabsorption or other disease which will affect the drug absorption. 9. Female: Women with childbearing potential must have a negative pregnancy test performed within 7 days prior to treatment, or must use an approved contraceptive method during and for 3 months after the study; must have a negative serum or urine pregnancy test, and must not be breast-feeding. Male: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment. 10. Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received HER/EGFR inhibitor and other molecular target drugs (micromolecular drug or MoAb) in other study, including endostar, Avastin?Iressa, Tarceva, Sutent, Nexavar, Sprycel, Erbitux and Herceptin; 2. concurrent treatment with sodium phenytoin, carbamazepine, rifampin, barbital or Sant Jone grass; 3. Have a known hypersensitivity to icotinib or any of the excipient of icotinib; 4. Have received treatment within the last 30 days with other study drug or a drug that has not received regulatory approval for any indication at the time of study entry; 5. Organ or system status: 1) Known brain metastasis diagnosed recently which have not received surgery or radiotherapy. Patients has been off corticosteroids for at least 4 weeks before start study therapy if have prior CNS metastases or oppressing spinal cord requiring corticosteroids treatment for unstable status; 2) Have interstitial lung disease; have drug-induced pneumonia; have radiation pneumonia which requires treat with corticosteroids, have active interstitial lung disease evident on clinical evaluation; 3) Have pre-existing idiopathic pulmonary fibrosis as evidenced by CT scan at baseline. Any serious or uncontrollable disease concomitant systemic disorder (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders.) judged by the investigator according to evidence; 4) Any unstable systemic disorders (including active infection, hypertension grade IV, unstable angina pectoris, congestive heart failure, liver and kidney disorder or metabolism disease); 5) No other malignancies diagnosed within the last 5 years with the exception of basal cell; 6) Carcinoma or treated cerviccal cancer in situ or squamous Cell Carcinoma of the Skin; 7) Any remarkable eye disorders, especially severe dry eye syndrome, dry kerato- conjunctivitis, Sjgren syndrome, serious exposition keratitis or other disease that possibly cause damage to epithelia of cornea. Not using contact lens will be better during the study, and whether or not using contact lens will be decided after discussing with oncologist and oculist; 8) Have clinically detectable (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry; 9) History of nerve or psychiatric disorder, including epilepsy or dementia; 6. Inadequate organ function including the following: 1) Absolute neutrophil (segmented and bands) count (ANC) 1.5*upper limit of normal (ULN); 3) Creatinine>1.5*upper limit of normal (ULN) or calculated creatinine clearance (CrCl) 2.5*ULN if the liver has no tumor involvement, aspartate transaminase (AST) and alanine transaminase (ALT) >5*ULN if the liver has tumor involvement; 5) Lung function disorder confirmed by clinical examination or PaO2=10%), over the previous 6 weeks before study entry; 8) >grade 2 uncured chronic toxic response (except alopecia) according to NCI-CTC (National Cancer Institute Common Terminology Criteria version 3.0); 7. Have previously registration or withdrawn from this study; 8. Concurrent administrati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, ORR, DCR, QoL and safety; | — |
Countries
China
Contacts
Public ContactSun Yan
Outcome results
None listed