Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment icotinib
Phase phase 4
Target EGFR
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date July 2012
End date December 2015
Trial size 35 participants
Trial identifier NCT01646450, BD-IC-IV20

Summary

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Icotinib: 125mg, oral administration, three times per day.
icotinib BPI-2009
Icotinib: 125mg, oral administration, three times per day.

Primary Outcomes

Measure
Progression free survival
time frame: 12 months

Secondary Outcomes

Measure
Overall survival
time frame: 24 months
Objective response rate
time frame: 3-6 months
Number of Participants with Adverse Events as a Measure of Safety
time frame: 18 months

Eligibility Criteria

Male or female participants from 70 years up to 80 years old.

Inclusion Criteria: - Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients. - Positive EGFR Mutation. - No previous systemic anticancer therapy. - Male and female patients aged over 70 years. - Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. - Provision of written informed consent. Exclusion Criteria: - Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). - Known severe hypersensitivity to icotinib or any of the excipients of this product. - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Additional Information

Official title An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
Principal investigator Han Baohui, MD
Description A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR. - Primary endpoint to assess progression-free survival - Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..