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

NCT01522833 | Completed

• 1 other identifier: SCRI OUTCOMES 13
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSLCL; Erlotinib; Tarceva

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Biomarker characteristics

  24 months

• Exploratory genetic analysis

  24 months

Study Arms (2)

Cohort A

EGFR Wild Type patients

Cohort B

EGFR mutation patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

EGFR-wt and EGFR mutation positive advanced NSCLC patient cases with an erlotinib-treatment duration of six months or longer (as 2nd/3rd line and/or maintenance single-agent therapy) in a community-based setting

You may qualify if:

• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue-testing will be performed or test results will be reviewed to identify EGFR-wt and EGFR mutation positive advanced non small cell lung cancer (NSCLC) patient cases with an erlotinib-treatment duration of six months or longer (as 2nd/3rd line and/or maintenance single-agent therapy) in a community-based setting. Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.

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

• David R Spigel, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 1, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

US (1)