Study identifier:NIS-OTW-ATC-2013/1
ClinicalTrials.gov identifier:NCT01947868
EudraCT identifier:N/A
CTIS identifier:N/A
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
Non-small-cell lung cancer
N/A
No
-
All
346
Observational
20 Years - 150 Years
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Taichung, Taiwan, Province of China
Arms | Assigned Interventions |
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