Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

Inclusion Criteria: * Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy * Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy ≥12 weeks * Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations；Must haved evidence of MET exon 14 skipping alterations in blood and/or tissue samples. * Adequate bone marrow, hepatic, and renal function * Patients of child bearing potential must agree to take contraception during the study and for 3 months after the last day of treatment * Signed Informed Consent Form Exclusion Criteria: * Prior or current treatment with the type II of c-MET inhibitor or HGF/c-Met antibody therapy * Confirmed ALK or ROS1 rearrangement * Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs,the tpye I of MET TKIs, etc.) within 14 days or 5 half-life * Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks * Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance * History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion * Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease * Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) * History of organ transplant; had surgery or severe injury within 4 weeks * Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ） * Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption. * Pregnant (positive pregnancy test) or lactating women