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

Launched by BARBARA ANN KARMANOS CANCER INSTITUTE · Jun 26, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at how a detailed examination of genes in tumor samples can help doctors better understand and treat patients with recurrent or stage IV non-small cell lung cancer. By analyzing the DNA from these tumors, the researchers hope to find specific changes or mutations that can guide tailored treatments for individuals, potentially improving their care.

To be eligible for this trial, patients should have recurrent or stage IV non-small cell lung cancer and either have a tissue sample available from a previous biopsy or be willing to have a new biopsy. Participants should be in fairly good health, with a life expectancy of at least three months, and meet certain blood count and organ function criteria. If you join this study, you will undergo a biopsy to collect tumor tissue for testing, and you’ll be asked to sign a consent form that explains the study’s details. It’s important to note that patients who are pregnant, breastfeeding, or have certain serious health issues may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• 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 including but 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