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

Completed

• Conditions: Non-Small-Cell Lung Cancer

• Registration Number: NCT01947868
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-23
• Study Start: 2013-11
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	15 months	LCS is Lung Cancer Scale

Secondary Outcome Measures

Name	Time	Method
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	FACT-L is Functional Assessment of Cancer Therapy-Lung questionnaire. TOI is Treatment Outcome Index. LCS is Lung Cancer Scale.
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	LCS is Lung Cancer Scale
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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan