RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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.

Quick Facts

Study Start:2014-08-01

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02178163

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Gerold Bepler, M.D.

CONTACT

(313) 576-8665

Principal Investigator

Gerold Bepler, M.D.

PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Study Locations (Sites)

KCI at McLaren Bay Region

Bay City, Michigan, 48708

United States

KCI at Mclaren Bloomfield Hills

Bloomfield Hills, Michigan, 48302

United States

KCI At McLaren Clarkston

Clarkston, Michigan, 48346

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

KCI at McLaren Flint

Flint, Michigan, 48532

United States

KCI at McLaren Greater Lansing, Mid Michigan Physicians

Lansing, Michigan, 48910

United States

KCI at McLaren Lapeer Region

Lapeer, Michigan, 48446

United States

KCI at McLaren Macomb

Mount Clemens, Michigan, 48043

United States

KCI at McLaren Central Michigan

Mount Pleasant, Michigan, 48858

United States

KCI at Northern Michigan

Petoskey, Michigan, 49770

United States

KCI at McLaren Port Huron

Port Huron, Michigan, 48060

United States

Collaborators and Investigators

Sponsor: Barbara Ann Karmanos Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-08-01

Study Completion Date2026-07

Study Record Updates

Study Start Date2014-08-01

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

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