Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

OBJECTIVES:

Primary

- Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung
cancer specimens from clinical trial CASE-2507.

- Investigate EGFR DNA copy-number changes.

- Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as
potential mechanisms of resistance.

OUTLINE: This is a multicenter study.

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/
reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance
mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed
using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in
these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear
cells positive for epithelial cell adhesion molecule (EpCAM).

DISEASE CHARACTERISTICS:

- Eligible for and concurrently enrolled on clinical trial CASE-2507

PATIENT CHARACTERISTICS:

- Willing and able to comply with scheduled visits, treatment plans, laboratory tests,
and other study procedures

- Normal coagulation profile and platelet count > 100,000/mm³*

- Not pregnant NOTE: *For patients who have not had a second biopsy procedure already
at the time of progression on erlotinib hydrochloride therapy and require a research
biopsy.

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin)

- No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet
agents)* NOTE: *For patients who have not had a second biopsy procedure already at
the time of progression on erlotinib hydrochloride therapy and require a research
biopsy.