This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) and help doctors to tailor treatment to target the specific mutations.
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
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
Single group
cytology specimen collection procedure
Other interventionCorrelative studies
laboratory biomarker analysis
Other interventionCorrelative studies
Proportion of patients receiving therapy based on genomic analyses among all eligible patients
Will be estimated with 95% confidence interval (CI) using the Wilson's method.
Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1
Response rate will be estimated with 95% Wilson's CI.
Progression free survival (PFS)
PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
Overall survival (OS)
Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
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Barbara Ann Karmanos Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
