NCT02178163

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2014Jul 2027

First Submitted

Initial submission to the registry

June 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

12.9 years

First QC Date

June 26, 2014

Last Update Submit

July 22, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients receiving therapy based on genomic analyses among all eligible patients

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

    Up to 21 days

Secondary Outcomes (3)

  • Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1

    Up to 2 years

  • Progression free survival (PFS)

    Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years

  • Overall survival (OS)

    From date of registration to up to 2 years

Study Arms (1)

Ancillary-Correlative (comprehensive genomic analysis)

EXPERIMENTAL

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

Other: cytology specimen collection procedureOther: laboratory biomarker analysis

Interventions

cytology specimen collection procedureOTHER

Correlative studies

Also known as: cytologic sampling
Ancillary-Correlative (comprehensive genomic analysis)
laboratory biomarker analysisOTHER

Correlative studies

Ancillary-Correlative (comprehensive genomic analysis)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

KCI at McLaren Bay Region

Bay City, Michigan, 48708, United States

RECRUITING

KCI at Mclaren Bloomfield Hills

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

KCI At McLaren Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

KCI at McLaren Flint

Flint, Michigan, 48532, United States

RECRUITING

KCI at McLaren Greater Lansing, Mid Michigan Physicians

Lansing, Michigan, 48910, United States

RECRUITING

KCI at McLaren Lapeer Region

Lapeer, Michigan, 48446, United States

RECRUITING

KCI at McLaren Macomb

Mount Clemens, Michigan, 48043, United States

RECRUITING

KCI at McLaren Central Michigan

Mount Pleasant, Michigan, 48858, United States

RECRUITING

KCI at Northern Michigan

Petoskey, Michigan, 49770, United States

RECRUITING

KCI at McLaren Port Huron

Port Huron, Michigan, 48060, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gerold Bepler, M.D.

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerold Bepler, M.D.

CONTACT

(313) 576-8665

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 30, 2014

Study Start

August 1, 2014

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(11)