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HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

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ClinicalTrials.gov Identifier: NCT00896909
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

Condition or disease Intervention/treatment
Lung Cancer Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis

Detailed Description:


  • Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
  • Correlate mutations with time to progression and survival of these patients.

OUTLINE: This is a multicenter study.

Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.

PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Study Design

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evaluation of HER2 Mutations in Patient Tumors From E2598
Actual Study Start Date : February 2, 2006
Primary Completion Date : July 2, 2006
Study Completion Date : July 2, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Correlation of HER-2 mutation with response, time to progression, and survival

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:

    • Recurrent disease
    • Stage IIIB with pleural or pericardial effusion
    • Stage IV disease
  • Treated on protocol ECOG-2598


  • Not specified


  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896909

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00896909     History of Changes
Other Study ID Numbers: CDR0000476582
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms