D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer

Inclusion Criteria: * Aged at least 18 years. * Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic. * Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib. * patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI. * Eastern cooperative oncology group performance status (ECOG PS) of 0-1. * a minimum life expectancy of 12 weeks. * At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1. * Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period. Exclusion Criteria: * Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI. * Unresolved toxicities from prior therapy. * Unstable spinal cord compression/brain metastases. * Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection. * QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period. * Severe respiratory diseases such as interstitial l…