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

Non Small Cell Lung Cancer Clinical Trial

Official title:

Non-Small-Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer: Demographics, Treatment and Outcome Characteristics of Patient Cases in a Community-Based Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522833
• Other study ID #: SCRI OUTCOMES 13
• Status: Completed
• Phase: N/A
• First received: January 25, 2012
• Last updated: March 4, 2016
• Start date: October 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographics	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.	24 months	No
Primary	treatment characteristics	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.	24 months	No
Primary	outcome characteristics	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.	24 months	No
Secondary	Biomarker characteristics	To explore biomarker (BM) characteristics of EGFR-wt erlotinib responders.	24 months	No
Secondary	Exploratory genetic analysis	Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.	24 months	No