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

NCT ID: NCT01522833

Last Updated: 2016-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort A

EGFR Wild Type patients

No interventions assigned to this group

Cohort B

EGFR mutation patients

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Spigel, MD

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

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Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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SCRI OUTCOMES 13

Identifier Type: -

Identifier Source: org_study_id

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