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

Simcere

Status and phase

Unknown

Phase 4

Conditions

Non-small Cell Lung Cancer (NSCLC)

Treatments

Drug: Gemcitabine-Cisplatin chemotherapy

Drug: Endostar

Study type

Interventional

Funder types

Other

Identifiers

NCT01028729

SIM090801

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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