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

ECOG-ACRIN Cancer Research Group

Status: Completed

Conditions: Lung Cancer

Treatments: Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: mutation analysis; Other: diagnostic laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00896909

ECOG-E2598T1

CDR0000476582

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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