Clinical trial NCT01947868: Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 346
Sex: ALL
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced NSCLC patients who will be treated as first line treatment with EGFR-TKI

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 15 months
Secondary outcomes:
measure: 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.
timeFrame: 15 months
measure: Mean change from baseline to Week 2, 4 and 12 in FACT-L, TOI and LCS.
timeFrame: 15 months
measure: 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.
timeFrame: 15 months
measure: 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
timeFrame: 15 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: 886422062121
name: Te-Chun Hsia
role: PRINCIPAL_INVESTIGATOR
References: