Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-26 @ 9:54 AM
Study NCT ID:
NCT01947868
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: