Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• •1.18 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy ≥ 3 months.
• •3.Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .
• •5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.
• •6\. Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.1.
• •8.The main organs function are normally, the following criteria are met:
• •1. routine blood tests（no blood transfusion and blood products within 14 days）：hemoglobin（Hb）≥90g/L；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
• •2. Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)；Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
• •3. left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.
• •9.Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.