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

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947868
• Other study ID #: NIS-OTW-ATC-2013/1
• Status: Completed
• Phase: N/A
• First received: September 18, 2013
• Last updated: September 22, 2016
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 130 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small-Cell Lung Cancer

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   NIS-OTW-ATC-2013_1_CSR_Synopsis.pdf