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

AstraZeneca

Status: Completed

Conditions: Non-Small-Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01947868

NIS-OTW-ATC-2013/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 patients

Sex: All

Ages: 20 to 130 years old

Volunteers: No Healthy Volunteers

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.