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

Running, not enrolling · Not applicable

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT02178163
Run by: Barbara Ann Karmanos Cancer Institute
People needed: 619
Starts: 2014-08-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

KCI at McLaren Bay Region — Bay City, Michigan, United States
KCI at Mclaren Bloomfield Hills — Bloomfield Hills, Michigan, United States
KCI At McLaren Clarkston — Clarkston, Michigan, United States
Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
KCI at McLaren Flint — Flint, Michigan, United States
KCI at McLaren Greater Lansing, Mid Michigan Physicians — Lansing, Michigan, United States
KCI at McLaren Lapeer Region — Lapeer, Michigan, United States
KCI at McLaren Macomb — Mount Clemens, Michigan, United States
KCI at McLaren Central Michigan — Mount Pleasant, Michigan, United States
KCI at Northern Michigan — Petoskey, Michigan, United States
KCI at McLaren Port Huron — Port Huron, Michigan, United States

Full record on ClinicalTrials.gov

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