First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 nonsmall-cell-lung-cancer
Started Jul 2012
Typical duration for phase_4 nonsmall-cell-lung-cancer
1 active site
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
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 9, 2015
September 1, 2015
3.4 years
July 17, 2012
September 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
12 months
Secondary Outcomes (3)
Overall survival
24 months
Objective response rate
3-6 months
Number of Participants with Adverse Events as a Measure of Safety
18 months
Study Arms (1)
Icotinib
EXPERIMENTALIcotinib: 125mg, oral administration, three times per day.
Interventions
Icotinib: 125mg, oral administration, three times per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han Baohui, MD
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 20, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
September 9, 2015
Record last verified: 2015-09