NCT00896909

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
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
GENETIC	gene expression analysis
GENETIC	mutation analysis
GENETIC	polymerase chain reaction
OTHER	diagnostic laboratory biomarker analysis

Timeline

• Start date: 2006-02-02
• Primary completion: 2006-07-02
• Completion: 2006-07-02
• First posted: 2009-05-12
• Last updated: 2017-05-17