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Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

Lung Cancer Clinical Trial

Official title:
A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Clinical Trial Summary

This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.

Clinical Trial Description

1. Open-label, single-arm, prospective pilot study.

2. Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation).

3. Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required.

4. Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.

5. Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).

6. QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.

7. All patients who prematurely discontinue treatment for any reason will be followed for survival. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02375022
Study type Interventional
Source Zhejiang University
Contact
Status Recruiting
Phase Phase 2
Start date March 2015
Completion date March 2016
View Details
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