Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

Study Overview
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Brief Summary
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Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.

Official Title
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The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Endostar
* Drug: Docetaxel
* Drug: Carboplatin
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination; Phase IIIB/IV based on TNM criteria (8th); At least one measurable tumor based on RECIST 1.1; Without the known active mutation of EGFR/ALK/ROS1/RET; Male or female, age≥18 or ≤70 years old; ECOG PS: 0 or 1; Estimated time of survival: ≥ 3 months; Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL; Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN; Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min; EKG normal; Without healing wound; No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment; For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment; No history of serious allergic to biologic agents, especially E.Coli products; The authorized ICF must be signed. Exclusion Criteria: Woman in pregnancy and breast-feeding, or having productive ability without contraception; Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound; Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension; Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms; Having the tendency of bleeding, such as FIB≤2G/L; Being receiving adjuvant chemotherapy; On other conditions investigator considers, the subject is not fitful to participate the 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 continuous intravenous infusion<br>Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin | Drug: Endostar<br>* continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.<br>Drug: Docetaxel<br>* docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle<br>Drug: Carboplatin<br>* carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed<br>Drug: Pemetrexed<br>* pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | objective response rate based on Recist 1.1 edition | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progress free survival | 8 weeks |