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.

Who is this study for? Patients with non-small cell lung cancer that has come back or is stage IV
What treatments are being studied? Cytology specimen collection procedure+Laboratory biomarker analysis
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
KCI at McLaren Bay Region
RECRUITING
Bay City
KCI at Mclaren Bloomfield Hills
RECRUITING
Bloomfield Hills
KCI At McLaren Clarkston
RECRUITING
Clarkston
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
KCI at McLaren Flint
RECRUITING
Flint
KCI at McLaren Greater Lansing, Mid Michigan Physicians
RECRUITING
Lansing
KCI at McLaren Lapeer Region
RECRUITING
Lapeer
KCI at McLaren Macomb
RECRUITING
Mount Clemens
KCI at McLaren Central Michigan
RECRUITING
Mount Pleasant
KCI at Northern Michigan
RECRUITING
Petoskey
KCI at McLaren Port Huron
RECRUITING
Port Huron
Contact Information
Primary
Gerold Bepler, M.D.
(313) 576-8665
Time Frame
Start Date: 2014-08-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 1020
Treatments
Experimental: Ancillary-Correlative (comprehensive genomic analysis)
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.
Sponsors
Leads: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov