A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) (NSCLC)
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ClinicalTrials.gov Identifier: NCT01028729 |
Recruitment Status
: Unknown
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was: Recruiting
First Posted
: December 9, 2009
Last Update Posted
: December 9, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer (NSCLC) | Drug: Endostar Drug: Gemcitabine-Cisplatin chemotherapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | July 2011 |
Estimated Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Endostar with chemotherapy
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.
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Drug: Endostar
7.5mg/m2/day, iv, from day 1 to day 14
Other Name: Recombinant Human Endostatin Injection
Drug: Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Other Name: GP chemotherapy
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- Progression Free Survival (PFS) [ Time Frame: July 2011 ]
- Objective Response Rate (ORR) [ Time Frame: July 2011 ]
- Clinical Benefit Response (CBR) [ Time Frame: July 2011 ]
- Overall Survival (OS) [ Time Frame: July 2011 ]
- Survival Rate [ Time Frame: one year ]
- Adverse Events [ Time Frame: July 2011 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028729
Contact: Yiping Zhang, Dr. | 86-0571-88122188 |
China, Zhejiang | |
Zhejiang Cancer Hospital | Recruiting |
Hangzhou, Zhejiang, China, 310022 | |
Contact: Yiping Zhang, Dr. 86-0571-88122188 |
Principal Investigator: | Yiping Zhang, Dr. | Zhejiang Cancer Hospital |
Responsible Party: | Jinsheng Ren, Simcere Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01028729 History of Changes |
Other Study ID Numbers: |
SIM090801 |
First Posted: | December 9, 2009 Key Record Dates |
Last Update Posted: | December 9, 2009 |
Last Verified: | December 2009 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Endostatins Antineoplastic Agents |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |