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

Evaluation of HER2 Mutations in Patient Tumors From E2598

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00896909

Enrollment

Registered

2009-05-12

Start date

2006-02-02

Completion date

2006-07-02

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

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.

Detailed description

OBJECTIVES: * 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.

Interventions

GENETICgene expression analysis

GENETICmutation analysis

GENETICpolymerase chain reaction

OTHERdiagnostic laboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Correlation of HER-2 mutation with response, time to progression, and survival	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026