A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.
Summary
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.
Detailed description
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.
Arms & interventions
- Othercytology specimen collection procedure
Correlative studies
- Otherlaboratory biomarker analysis
Correlative studies
Outcome measures
Primary
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
Secondary
Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1
Time frame: Up to 2 years
Progression free survival (PFS)
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)
Time frame: From date of registration to up to 2 years
Eligibility criteria
Study locations (11)
KCI at McLaren Bay Region
Bay City, Michigan, 48708
KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan, 48302
KCI At McLaren Clarkston
Clarkston, Michigan, 48346
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
KCI at McLaren Flint
Flint, Michigan, 48532
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan, 48910
KCI at McLaren Lapeer Region
Lapeer, Michigan, 48446
KCI at McLaren Macomb
Mount Clemens, Michigan, 48043
KCI at McLaren Central Michigan
Mount Pleasant, Michigan, 48858
KCI at Northern Michigan
Petoskey, Michigan, 49770
KCI at McLaren Port Huron
Port Huron, Michigan, 48060