The purpose of this clinical study is to evaluate the tolerability and toxicity of different dose of Anlotinib puls Gefitinib in First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer , to provide a reference of dosage for Phase II clinical trials
Description: Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteriaMeasure: Dose limiting toxicity Time: From enrollment to completion of study. Estimated about 4 months.
Description: Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.Measure: Maximum tolerance dose Time: From enrollment to completion of study. Estimated about 4 months
Description: Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)Measure: disease control rate Time: From enrollment to 2 months after treatment
Description: The length of time from enrollment until the time of progression of disease (TTP, time to progression).Measure: time to progression Time: From enrollment to progression of disease. Estimated about 6 months
Single Group Assignment
There is one SNP
recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment） - Epidermal Growth Factor Receptor(EGFR)mutations confirmed by molecular detection (including, but not limited to, 20 exon, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - Patients have not been received systematic treatment，including chemotherapy and EGFR -TKIs（Tyrosine kinase inhibitors） - There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm. - Life expectancy ≥3 months. --- L858R ---