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

NCT01947868 | Completed

• 1 other identifier: NIS-OTW-ATC-2013/1
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

Eligibility Criteria

• Age: 20 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced NSCLC patients who will be treated as first line treatment with EGFR-TKI

You may qualify if:

• 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

You may not qualify if:

• \- Involvement in any planning and/or conduct of the clinical trial.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Related Links

• NIS-OTW-ATC-2013\_1\_CSR\_Synopsis.pdf

Biospecimen

Retention: NONE RETAINED

no biospecimen collected

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Te-Chun Hsia

  886422062121

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

TW (1)