Study of Endostar Subcutaneous Injection in NSCLC

A Single-arm, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Endostar Subcutaneous Injection in Chinese Advanced NSCLC Patients

This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.

Inclusion Criteria:

• Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC
• ECOG performance status 0-1
• Life expectancy≥3 months
• Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L;
• Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min;
• Normal coagulation function (PT, APTT, TT, Fbg) ;
• Patients signed informed consent form;
• Willingness and capability to comply with protocol requirement and well communicate with investigators.

Exclusion Criteria:

• With uncontrolled ascites or pleural effusion;
• Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study;
• History of ischemic or TIA within 6 months before enrollment;
• Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy;
• Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II；
• Serious active infections;
• History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
• Symptomatic brain or meningeal metastasis;
• Epileptic seizure need to be treated;
• HCV, HBV or HIV positive;
• History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma);
• Known allergies to any excipient in the study drug;
• Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study;
• Any conditions that may endanger patient safety or interfere with the patient's compliance;
• Pregnant and lactating women;
• The investigators consider the patients unsuitable for this trial