First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Icotinib: 125mg, oral administration, three times per day. | Drug: Icotinib<br>* Icotinib: 125mg, oral administration, three times per day.<br>* Other names: Commana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. | 24 months | 
| Objective response rate | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response. | 3-6 months | 
| Number of Participants with Adverse Events as a Measure of Safety | Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, EGFR Mutation, Elder patients