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

Phase 3

• Conditions: Advanced Cancer; Lung Cancer, Nonsmall Cell
• Interventions: Drug: EGFR-TK Inhibitor

• Registration Number: NCT03008109
• Lead Sponsor: Zaiwen Fan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2016-12-29
• Status Verified: 2017-01
• Study First Posted: 2017-01-02
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04
• Study Start: 2017-02
• Primary Completion: 2017-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGFR-TK inhibitor plus RH-endostatin	EGFR-TK Inhibitor	EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7

Primary Outcome Measures

Name	Time	Method
progression-free survival	18 month