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Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

Primary Purpose

Advanced Cancer, Lung Cancer, Nonsmall Cell

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

EGFR-TK Inhibitor

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring EGFR-TKI, Recombinant human endostatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions

Exclusion Criteria:

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EGFR-TK inhibitor plus RH-endostatin

Arm Description

EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03008109

First Posted

December 29, 2016

Last Updated

January 2, 2017

Sponsor

Zaiwen Fan

1. Study Identification

Unique Protocol Identification Number

NCT03008109

Brief Title

Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

Official Title

Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2017 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zaiwen Fan

4. Oversight

5. Study Description

Brief Summary

EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS （progression-free survival） , the OS （ overall survival） is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Cancer, Lung Cancer, Nonsmall Cell

Keywords

EGFR-TKI, Recombinant human endostatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EGFR-TK inhibitor plus RH-endostatin

Arm Type

Experimental

Arm Description

EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7

Intervention Type

Drug

Intervention Name(s)

EGFR-TK Inhibitor

Other Intervention Name(s)

Recombinant human endostatin

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

18 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zaiwen Fan, MD

Phone

+86 18610949919

kzzaiwenfan@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaoyuan Shi, Bachelor

Phone

+86 15801570739

szy957@aliyun.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

27209164

Citation

Gridelli C, Rossi A, Ciardiello F, De Marinis F, Crino L, Morabito A, Morgillo F, Montanino A, Daniele G, Piccirillo MC, Normanno N, Gallo C, Perrone F. BEVERLY: Rationale and Design of a Randomized Open-Label Phase III Trial Comparing Bevacizumab Plus Erlotinib Versus Erlotinib Alone as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2016 Sep;17(5):461-465. doi: 10.1016/j.cllc.2016.04.001. Epub 2016 Apr 22.

Results Reference

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Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

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