A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Study Phase
Phase 4
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Endostar Type: Drug
Name: Gemcitabine-Cisplatin chemotherapy Type: Drug
Overall Status
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Yiping Zhang, Dr. - 86-0571-88122188
Start Date
September 2009
Completion Date
August 2011
Simcere Pharmaceutical Co., Ltd
Simcere Pharmaceutical Co., Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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