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Comprehensive Genomic Analysis in Tissue Samples from Patients with Recurrent or Stage IV Non-small Cell Lung Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Stage IV or recurrent non-small cell lung cancer
  • Patients who have archival tissue for genomic analysis, are willing and able to undergo a new biopsy to obtain tumor tissue for genomic analysis, or whose tumor has already undergone genomic analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy >= 3 months
  • Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines

Exclusion Criteria

  • 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 that may affect the clinical outcome of the patient, as determined by the treating physician; serious medical illness includes but is 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

Michigan

Bay City
McLaren Cancer Institute-Bay City
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Bloomfield
McLaren Cancer Institute-Bloomfield
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8655
Clarkston
McLaren Cancer Institute-Clarkston
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Flint
McLaren Cancer Institute-Flint
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Lansing
McLaren-Greater Lansing
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Mid-Michigan Physicians-Lansing
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Mount Clemens
McLaren Cancer Institute-Macomb
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8655
Port Huron
McLaren-Port Huron
Status: ACTIVE
Contact: Gerold Bepler
Phone: 313-576-8665

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 Phase Phase NA

Trial Type Treatment

Lead Organization
Wayne State University / Karmanos Cancer Institute

Principal Investigator
Gerold Bepler

  • Primary ID 2014-002
  • Secondary IDs NCI-2014-00913, W81XWH-11-1-0500, 1402012837
  • Clinicaltrials.gov ID NCT02178163