Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT01522833
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Study Start: 2012-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Patients must have had NSCLC.
• Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy.
• Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available.
• Patients must have tissue available for exploratory genetic analysis.
• Patients must have all clinical information, treatment response data and outcomes data available for review.
• Patients must be deceased.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
demographics	24 months	To describe patient demographic characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Demographic characteristics include age, race,ethnicity, date of initial diagnosis, age at initial diagnosis, location of biopsy at diagnosis, extent of disease with description and location of metastatic sites, histology,and smoking history.
outcome characteristics	24 months	To describe patient outcome characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt including the reason for discontinuing erlotinib treatment, best response to erlotinib treatment and did patient receive any dose modifications while receiving erlotinib treatment.
treatment characteristics	24 months	To describe patient treatment and characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Including number and kind of prior therapies, disease stage at initial diagnosis, sites of metastasis at time of erlotinib treatment, prior surgery, and radiation.

Secondary Outcome Measures

Name	Time	Method
Biomarker characteristics	24 months	To explore biomarker (BM) characteristics of EGFR-wt erlotinib responders.
Exploratory genetic analysis	24 months	Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States