NCT01646450UnknownPhase 4
An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
Betta Pharmaceuticals Co., Ltd.1 site in 1 country35 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to 80 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Icotinib
Experimental
Icotinib: 125mg, oral administration, three times per day.
Intervention: Icotinib (Drug)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 12 months
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.
Secondary Outcomes
- Objective response rate(3-6 months)
- Number of Participants with Adverse Events as a Measure of Safety(18 months)
- Overall survival(24 months)
Investigators
Study Sites (1)
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