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Genomic Analysis for Recurrent or Stage IV Non-Small Cell Lung Cancer

This study is looking at how comprehensive genomic analysis (a detailed look at your genes) in tumor tissue samples can help guide treatment for non-small cell lung cancer that has come back or is at an advanced stage (Stage IV). The goal is to see if identifying specific gene changes (mutations in DNA) can help doctors choose more personalized treatments. You might be able to join if you have Stage IV or recurrent non-small cell lung cancer, have a good general health status, and a life expectancy of at least 3 months. The main thing the researchers want to find out is what percentage of patients receive treatment based on these genomic analyses.

Study design
This is an interventional study with a planned enrollment of 1020 participants. It aims to see how genomic analysis can guide treatment decisions.
What's involved
You would provide tissue samples for genomic analysis, possibly through a new biopsy. After any study treatment, you would have follow-up appointments for up to 5 years or more.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up every 3 months for 2 years, then every 6 months for 3 years, and yearly thereafter.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02178163

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

Active, Not Recruiting
NAAges 18+Interventional
Barbara Ann Karmanos Cancer Institute
~619 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:cytology specimen collection procedurelaboratory biomarker analysis

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients receiving therapy based on genomic analyses among all eligible patients
Measured over Up to 21 days

Conditions

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

11 sites across 1 states
Michigan11

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients receiving therapy based on genomic analyses among all eligible patientsUp to 21 days

    Will be estimated with 95% confidence interval (CI) using the Wilson's method.