Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer

• Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing after first-line chemotherapy;
• Patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity;
• Age: 18-70 years old;
• Patients with wild-type EGFR;
• With a histologically or cytologically confirmed measurable disease (longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to Response Evaluation Criteria in Solid Tumors (RECIST Criteria);
• Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2;
• Must have an expected survival time of at least 12 weeks;
• Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb) ≥ 9g/dL;
• adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases);
• adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal;
• No malabsorption or other gastrointestinal disorders affecting drug absorption;
• Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.Male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment;
• Patients have provided a signed Informed Consent Form.

Exclusion Criteria:

• Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab;
• Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort;
• Allergic to icotinib or any of the excipients of this product.
• Prior chemotherapy with any paclitaxel agents;
• Central nervous system (CNS) metastases without radiotherapy and/or surgery;
• Evidence of clinically active Interstitial lung diseases;
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases;
• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ);
• Psychiatric illness that would prevent the patient from giving informed consent;
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study;
• Patient is concurrently using other approved or investigational antineoplastic agent;
• Pregnant or lactating women;
• Positive epidermal growth factor receptor mutation.