Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC
Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 4, 2017
January 1, 2017
9 months
December 29, 2016
January 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
18 month
Study Arms (1)
EGFR-TK inhibitor plus RH-endostatin
EXPERIMENTALEGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7
Interventions
Eligibility Criteria
You may qualify if:
- Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zaiwen Fanlead
Related Publications (1)
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.
PMID: 27209164BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of oncology department
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 2, 2017
Study Start
February 1, 2017
Primary Completion
November 1, 2017
Study Completion
November 1, 2018
Last Updated
January 4, 2017
Record last verified: 2017-01