Study of Endostar Subcutaneous Injection in NSCLC

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

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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Endostar
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostar-subcutaneous injection/Chemotherapy<br> | Drug: Endostar<br>* Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;<br>Drug: Chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events |  | until 30 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks | 
| AUC |  | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks | 
| Tmax |  | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks | 
| T1/2 |  | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks | 
| CL |  | day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks |