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

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Treatments: Cisplatin; Endostar protein; Endostatins; Gemcitabine

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