Comprehensive Genomic Analysis in Tissue Samples from Patients with Recurrent or Stage IV Non-small Cell Lung Cancer
- 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
- 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
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.
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.
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
Wayne State University / Karmanos Cancer Institute
- Primary ID 2014-002
- Secondary IDs NCI-2014-00913, W81XWH-11-1-0500, 1402012837
- Clinicaltrials.gov ID NCT02178163