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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— NSCLC  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01028729
• Other study ID #: SIM090801
• Status: Recruiting
• Phase: Phase 4
• First received: December 7, 2009
• Last updated: December 8, 2009
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2009
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Yiping Zhang, Dr.
• Phone: 86-0571-88122188
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Endostar
7.5mg/m2/day, iv, from day 1 to day 14
• Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		July 2011	No
Secondary	Objective Response Rate (ORR)		July 2011	No
Secondary	Clinical Benefit Response (CBR)		July 2011	No
Secondary	Overall Survival (OS)		July 2011	No
Secondary	Survival Rate		one year	No
Secondary	Adverse Events		July 2011	Yes