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

Last updated: July 16, 2024
Sponsor: Barbara Ann Karmanos Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

cytology specimen collection procedure

laboratory biomarker analysis

Clinical Study ID

NCT02178163
2014-002
P30CA022453
W81XWH-11-1-0500
2014-002
NCI-2014-00913
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archivaltissue for genomic analysis or are willing to undergo a new biopsy to obtain tumortissue for genomic analysis. Patients whose tumor has already undergone genomicanalysis 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) orcalculated creatinine clearance (Cockcroft-Gault formula) of > 45 mL/min

  • Serum bilirubin =< 1.5 X ULN

  • Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamatepyruvate transaminase [SGPT]) =< 2.5 times institutional ULN and alkalinephosphatase =< 2.5 times ULN, unless patient has liver metastases and the managingphysician believes that the elevation in liver enzymes is only related to the livermetastases

  • 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 biopsyspecimen can be an already obtained diagnostic specimen provided the patient has notreceived 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 thathas been radiated.

  • Signed informed consent that details the investigational nature of the studyaccording to institutional and federal guidelines

Exclusion

Exclusion Criteria:

  • Patients with concurrent malignancy; patients with prior or concurrent malignancywill be allowed as long as the treating physician considers it unlikely to impactthe clinical outcome of the patient

  • Serious medical illness including but not limited to uncontrolled congestive heartfailure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6months of registration, history of chronic active hepatitis or history of humanimmunodeficiency virus (HIV) or an active bacterial infection will not be eligible

  • Pregnant or lactating women; female patients of child bearing potential will beinformed that if they do enroll on a therapeutic trial, based on the genomicanalyses, that they may not be able to enroll on a clinical trial if they arepregnant; all sexually active patients will be informed that patients enrolling on atherapeutic trial have to use contraceptive methods to prevent pregnancy

Study Design

Total Participants: 1020
Treatment Group(s): 2
Primary Treatment: cytology specimen collection procedure
Phase:
Study Start date:
August 01, 2014
Estimated Completion Date:
July 31, 2026

Study Description

PRIMARY OBJECTIVES:

I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.

SECONDARY OBJECTIVES:

I. To estimate the percentage of patients in whom genomic analysis can be performed.

II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.

OUTLINE:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

Connect with a study center

  • KCI at McLaren Bay Region

    Bay City, Michigan 48708
    United States

    Active - Recruiting

  • KCI at Mclaren Bloomfield Hills

    Bloomfield Hills, Michigan 48302
    United States

    Active - Recruiting

  • KCI At McLaren Clarkston

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • KCI at McLaren Flint

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • KCI at McLaren Greater Lansing, Mid Michigan Physicians

    Lansing, Michigan 48910
    United States

    Active - Recruiting

  • KCI at McLaren Lapeer Region

    Lapeer, Michigan 48446
    United States

    Active - Recruiting

  • KCI at McLaren Macomb

    Mount Clemens, Michigan 48043
    United States

    Active - Recruiting

  • KCI at McLaren Central Michigan

    Mount Pleasant, Michigan 48858
    United States

    Active - Recruiting

  • KCI at Northern Michigan

    Petoskey, Michigan 49770
    United States

    Active - Recruiting

  • KCI at Northern Michigan Petoskey

    Petoskey, Michigan 49770
    United States

    Active - Recruiting

  • KCI at McLaren Port Huron

    Port Huron, Michigan 48060
    United States

    Active - Recruiting

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