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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
619
Correlative studies
Correlative studies
KCI at McLaren Bay Region
Bay City, Michigan, United States
KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan, United States
KCI At McLaren Clarkston
Clarkston, Michigan, United States
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.
Time frame: Up to 21 days
Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1
Response rate will be estimated with 95% Wilson's CI.
Time frame: Up to 2 years
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.
Time frame: Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years
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.
Time frame: From date of registration to up to 2 years
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
KCI at McLaren Flint
Flint, Michigan, United States
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan, United States
KCI at McLaren Lapeer Region
Lapeer, Michigan, United States
KCI at McLaren Macomb
Mount Clemens, Michigan, United States
KCI at McLaren Central Michigan
Mount Pleasant, Michigan, United States
KCI at Northern Michigan
Petoskey, Michigan, United States
...and 1 more locations