Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy
can be initiated based on genomic analysis of tumor specimens.

SECONDARY OBJECTIVES:

I. To estimate the percentage of patients in whom genomic analysis can be performed.

II. To assess the progression free survival and response rate in patients who start therapy
based on the genomic analyses results.

OUTLINE:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry,
polymerase chain reaction (PCR), and microarray. Based on the results of the genomic
analysis, patients may begin therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then every 12 months thereafter.

Inclusion Criteria:

- Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival
tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor
tissue for genomic analysis. Patients whose tumor has already undergone genomic
analysis will be eligible.

- Zubrod performance status 0-2

- Life expectancy >= 3 months

- Absolute neutrophil count of > 1.5 x 10^9/L

- Platelet count > 100,000 x 10^9/L

- Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN) or
calculated creatinine clearance (Cockcroft-Gault formula) of > 45 mL/min

- Serum bilirubin =< 1.5 X ULN

- Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamate
pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN and alkaline phosphatase
=< 2.5 times ULN, unless patient has liver metastases and the managing physician
believes that the elevation in liver enzymes is only related to the liver metastases

- Laboratory tests should be done within 30 days of enrollment on the trial

- A biopsy of the patient's tumor for genomic profiling is required; this biopsy
specimen can be an already obtained diagnostic specimen provided the patient has not
received systemic therapy since the biopsy has been obtained and was obtained within
60 days of trial enrollment. The biopsy material cannot be from a tumor site that has
been radiated.

- Signed informed consent that details the investigational nature of the study according
to institutional and federal guidelines

Exclusion Criteria:

- Patients with concurrent malignancy; patients with prior or concurrent malignancy will
be allowed as long as the treating physician considers it unlikely to impact the
clinical outcome of the patient

- Serious medical illness including but not limited to uncontrolled congestive heart
failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6
months of registration, history of chronic active hepatitis or history of human
immunodeficiency virus (HIV) or an active bacterial infection will not be eligible

- Pregnant or lactating women; female patients of child bearing potential will be
informed that if they do enroll on a therapeutic trial, based on the genomic analyses,
that they may not be able to enroll on a clinical trial if they are pregnant; all
sexually active patients will be informed that patients enrolling on a therapeutic
trial have to use contraceptive methods to prevent pregnancy