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

Description

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.

Conditions

Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Study Overview

Study Details

Study overview

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.

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.

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

Condition
Recurrent Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Bay City

KCI at McLaren Bay Region, Bay City, Michigan, United States, 48708

Bloomfield Hills

KCI at Mclaren Bloomfield Hills, Bloomfield Hills, Michigan, United States, 48302

Clarkston

KCI At McLaren Clarkston, Clarkston, Michigan, United States, 48346

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Flint

KCI at McLaren Flint, Flint, Michigan, United States, 48532

Lansing

KCI at McLaren Greater Lansing, Mid Michigan Physicians, Lansing, Michigan, United States, 48910

Lapeer

KCI at McLaren Lapeer Region, Lapeer, Michigan, United States, 48446

Mount Clemens

KCI at McLaren Macomb, Mount Clemens, Michigan, United States, 48043

Mount Pleasant

KCI at McLaren Central Michigan, Mount Pleasant, Michigan, United States, 48858

Petoskey

KCI at Northern Michigan, Petoskey, Michigan, United States, 49770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Barbara Ann Karmanos Cancer Institute,

Gerold Bepler, M.D., PRINCIPAL_INVESTIGATOR, Barbara Ann Karmanos Cancer Institute

Study Record Dates

2026-07