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

Phase 4

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Endostar; Drug: Gemcitabine-Cisplatin chemotherapy

• Registration Number: NCT01028729
• Lead Sponsor: Simcere Pharmaceutical Co., Ltd

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2009-12
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Last Update Submitted: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Posted: 2009-12-09
• Primary Completion: 2011-07
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar with chemotherapy	Gemcitabine-Cisplatin 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.
Endostar with chemotherapy	Endostar	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	July 2011

Secondary Outcome Measures

Name	Time	Method
Survival Rate	one year
Adverse Events	July 2011
Objective Response Rate (ORR)	July 2011
Overall Survival (OS)	July 2011
Clinical Benefit Response (CBR)	July 2011

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China