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)
18 Years
75 Years
Both
Non-small Cell Lung Cancer (NSCLC)
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Time Frame:
July 2011
Safety Issue:
No
Principal Investigator
Yiping Zhang, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Zhejiang Cancer Hospital
Authority:
China: Ethics Committee
Study ID:
SIM090801
NCT ID:
NCT01028729
Start Date:
September 2009
Completion Date:
August 2011
Related Keywords:
- Non-Small Cell Lung Cancer (NSCLC)
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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