A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).

Detailed Description
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All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.

Official Title
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A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: Endostar
* Drug: Gemcitabine-Cisplatin chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC At least one measurable lesion Age of 18-75 years Life expectancy > 3 months ECOG performance status 0-2 Adequate hematologic, renal, and hepatic function Exclusion Criteria: Prior systemic chemotherapy for NSCLC Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture) Concurrent anticoagulation therapy Evidence of bleeding diathesis or coagulopathy Pregnant or lactating women Allergic to E.coli preparation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 with chemotherapy<br>All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. | Drug: Endostar<br>* 7.5mg/m2/day, iv, from day 1 to day 14<br>* Other names: Recombinant Human Endostatin Injection;Drug: Gemcitabine-Cisplatin chemotherapy<br>* Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3<br>* Other names: GP chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | July 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | July 2011 | 
| Clinical Benefit Response (CBR) |  | July 2011 | 
| Overall Survival (OS) |  | July 2011 | 
| Survival Rate |  | one year | 
| Adverse Events |  | July 2011 |