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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03008109
• Other study ID #: AirFGH
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 29, 2016
• Last updated: January 2, 2017
• Start date: February 2017
• Est. completion date: November 2018

Study information

• Verified date: January 2017
• Source: Air Force General Hospital of the PLA
• Contact: Zaiwen Fan, MD
• Phone: +86 18610949919
• Email: kzzaiwenfan[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

Intervention

Drug:
• EGFR-TK Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zaiwen Fan

References & Publications (1)

Gridelli C, Rossi A, Ciardiello F, De Marinis F, Crinò 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		18 month	Yes