This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back (recurrent) 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02178163.
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 using all registered patients as the denominator.
II. To assess the progression free survival and response rate in patients who start targeted therapy after registration based on the genomic analyses results.
OUTLINE:
Patients undergo collection of tissue samples for genomic analysis via biopsy, arrayed comparative genomic hybridization approach (aCGH), cytogenomic analysis of copy number aberrations, lung cancer panel assay to analyze sequence mutations, and DNA and ribonucleic acid (RNA) isolation. Patients who have sufficient stored biopsy samples for genomic analysis may not need an additional biopsy. Based on the results of the genomic analysis, patients may begin therapy.
After completion of study, patients are followed up for at least 24 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorGerold Bepler