NCT01028729

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Endostar	7.5mg/m2/day, iv, from day 1 to day 14
DRUG	Gemcitabine-Cisplatin chemotherapy	Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2009-12-09
• Last updated: 2009-12-09

Locations

1 site across 1 country: China