Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Inclusion criteria:

1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients;
2. With at least one measurable solid tumor (RECIST standard version 1.1): tumor >=10 mm in diameter on CT or MRI images, or lymph node >=15 mm in diameter on CT or MRI images;
3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival > 3 months;
4. Age: 18-70 years;

5. Normal organ function:

   Bone marrow: neutrophils (ANC) count>=1.5×10^9/L, Platelets count>=100×10^9/L, hemoglobin>=90g/L；Renal function, serum creatinine<=1.5 mg/dl, and/or creatinine clearance or>=60 ml/min; Liver function: total serum bilirubin levels <= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT >=5 times ULN;

6. For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;
7. Informed consent.

Exclusion criteria:

1. Clinically significant hepatic dysfunction: AST or ALT > 2.5 times the ULN, total serum bilirubin levels > 1.5 times the ULN; clinically significant renal insufficiency: serum creatinine > 1.5 times the ULN;
2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization;
3. Spleen resection or combined with other severe hematopoietic system diseases;
4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers;
5. History or present with other cancer, except for non melanoma skin cancer, cervical cancer in situ and other cured cancer for at least 5 years;
6. Mental illness, without legal capacity or limited capacity;
7. Pregnancy, lactation or patients with pregnancy plan;
8. Participated in other clinical trail in the past 1 months or participating in other trail now;
9. Other unsuitable condition decided by the investigator.