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Completed

NCT Number: NCT01522833

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. demographics

    Time frame: 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.

  2. treatment characteristics

    Time frame: 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.

  3. outcome characteristics

    Time frame: 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.

Secondary outcomes

  1. Biomarker characteristics

    Time frame: 24 months

    To explore biomarker (BM) characteristics of EGFR-wt erlotinib responders.

  2. Exploratory genetic analysis

    Time frame: 24 months

    Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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