Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor

Study Overview
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Brief Summary
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This is an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. The Primary Objective is to estimate symptom improvement rates in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. A clinically meaningful improvement is defined as an increase from baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.

Detailed Description
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The Secondary Objectives are: To estimate symptom improvement rates at weeks 2 and 12 To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12. To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12. Subgroup information of symptom improvement rate, QoL and disease-related symptom scores by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites, female/never smokers and patients with COPD at week 2, week 4 and week 12.

Official Title
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A Prospective, Non-interventional Evaluation of Symptoms Improvement of First-Line Therapy of EGFR Tyrosine Kinase Inhibitor in Advanced NSCLC Patients With Positive EGFR Mutation - the SMILE Study

Conditions
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Non-Small-Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with symptomatic, locally advanced or metastatic (stage IIIb/IV) NSCLC. Patients who are positive for EGFR mutation Patients with a prescription of EGFR-TKI as their first-line treatment Exclusion Criteria: - Involvement in any planning and/or conduct of the clinical trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 130 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients demonstrating a clinically meaningful improvement post 4 weeks of EGFR-TKI therapy defined as an increase in LCS ≥ 2 points from baseline. | LCS is Lung Cancer Scale | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients demonstrating a clinically meaningful improvement post 2 weeks and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 2 points from baseline. |  | 15 months | 
| Mean change from baseline to Week 2, 4 and 12 in FACT-L, TOI and LCS. | FACT-L is Functional Assessment of Cancer Therapy-Lung questionnaire. TOI is Treatment Outcome Index. LCS is Lung Cancer Scale. | 15 months | 
| The proportion of patients demonstrating a clinically meaningful improvement post 2, 4 and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 7 points from baseline. | LCS is Lung Cancer Scale | 15 months | 
| Descriptive statistics in improvement rate (defined as LCS ≥ 2 points changed from baseline), QoL and disease-related symptom scores at week 2,4 and 12 and summarized by gender, smoking status, smoking pattern, WHO performance status, etc |  | 15 months |