Epidermal Growth Factor Receptor-tested Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01522833
First received: January 25, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EGFR-tested 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • demographics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • treatment characteristics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • outcome characteristics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Biomarker characteristics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To explore biomarker (BM) characteristics of EGFR-wt erlotinib responders.

  • Exploratory genetic analysis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Biopsy specimens from enrolled patient cases who are EGFR-wt will be evaluated via exploratory genetic analysis for correlated biomarkers.


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.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort A
EGFR Wild Type patients
Cohort B
EGFR mutation patients

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522833

Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
Study Chair: David R Spigel, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01522833     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 13
Study First Received: January 25, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
NSLCL
Erlotinib
Tarceva

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014