Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC

Inclusion Criteria

• •1. First-line patients with locally advanced or metastatic NSCLC (Clinical Stage of ⅢB/Ⅳ, TNM (primary tumor, regional nodes, metastasis) Staging Edition 7) confirmed by histological or cytological diagnosis or of postoperative recurrence;
• •First-line patients include:
• •1. Patients who are newly diagnosed as ⅢB/Ⅳ and have undergone no radiotherapy or chemotherapy or molecular targeting treatment;
• •2. Patients with postoperative reoccurrence and metastasis and receiving no adjuvant radiotherapy or chemotherapy or molecular targeting treatment;
• •3. Patients with postoperative reoccurrence and metastasis and receiving adjuvant radiotherapy or chemotherapy or molecular targeting treatment, but it has been more than one year since the end of such therapies or treatment.
• •4. Patients who have received prior radiotherapy can be enrolled. However, the radiation area must be \<25% of bone marrow area, the prior radiotherapy has been completed at least 4 weeks before the enrollment, and the acute radiation toxicity must have been restored. Local lesions that have undergone radiotherapy are not allowed to be included in the measurable lesions save as such lesions with significant progress recorded after the last radiotherapy.
• •2. Patients with available measurable lesions in line with the requirements of "measurable lesions" in the response evaluation criteria "RECIST Version 1.1". Lesions with at least one accurately measurable diameter (serve as the maximum diameter): the maximum diameter of target lesions with CT scan ≥20 mm or the maximum diameter with spiral CT or MRI scan ≥10 mm;
• •3. ECOG (Eastern Cooperative Oncology Group) score ≤ 1 points and expected survival of at least 3 months;
• •4. 18 to 70 years old, male or female;
• •5. Blood picture and functions of major organs such as heart, lung, liver, kidneys are basically normal.
• •6. Blood routine test must meet the following criteria:
• •1. ANC≥1.5×109/L；
• •2. PLT≥100×109/L；
• •3. Hb≥90g/L。
• •7. Blood biochemical test must meet the following criteria:
• •1. Plasma total bilirubin ≤1.5 × upper limit of normal (ULN);
• •2. ALT (Alanine aminotransferase), AST (Aspartate transaminase) or AKP≤2.5 × ULN (for patients with hepatic metastases, ALT, AST or AKP≤5 × ULN; for patients with bone metastases, AKP≤10 × ULN);
• •3. Cr ≤1.5 × ULN;
• •8. Patients have no cardiac insufficiency symptoms at baseline; no serious abnormal signs in ECG
• •9. Efficacy of cancer-related imaging examinations are completed within 2 weeks before enrollment and clinical condition assessment, the three routine tests of blood, urea, and stool, blood biochemical examination, ECG, CEA (carcinoembryonic antigen) and other examinations completed within 1 week before enrollment;
• •10. Patients can understand the purpose of the clinical trial, participate out of their own will, and sign the informed consent;
• •11. Patients have good compliance, accept the doctor's follow-up evaluations, and voluntarily follow treatment protocol during the study;
• •12. Male or female patients with childbearing potential voluntarily take contraceptive measures during the trial.