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)
Overview
- Phase
- Phase 4
- Intervention
- Endostar
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Sponsor
- Simcere Pharmaceutical Co., Ltd
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Progression Free Survival (PFS)
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Arms & Interventions
Endostar with chemotherapy
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.
Intervention: Endostar
Endostar with chemotherapy
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.
Intervention: Gemcitabine-Cisplatin chemotherapy
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: July 2011
Secondary Outcomes
- Objective Response Rate (ORR)(July 2011)
- Overall Survival (OS)(July 2011)
- Survival Rate(one year)
- Adverse Events(July 2011)
- Clinical Benefit Response (CBR)(July 2011)