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

Inclusion Criteria:

* 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.