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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01028729

Acronym

NSCLC

Enrollment

120

Registered

2009-12-09

Start date

2009-09-30

Completion date

2011-08-31

Last updated

2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer (NSCLC)

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.

Interventions

DRUGEndostar

7.5mg/m2/day, iv, from day 1 to day 14

DRUGGemcitabine-Cisplatin chemotherapy

Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS)	July 2011

Secondary

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

Countries

China

Contacts

Primary ContactYiping Zhang, Dr.

86-0571-88122188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026