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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Small-Cell Lung Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 346
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
The Secondary Objectives are: 1. To estimate symptom improvement rates at weeks 2 and 12 2. To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12. 3. To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12. 4. 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Time Frame: 15 months
LCS is Lung Cancer Scale
Secondary Outcomes
- 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.(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.(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)