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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: cytology specimen collection procedure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 619
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Bay City, Michigan, United States, 48708
      • KCI at McLaren Bay Region
    • Bloomfield Hills, Michigan, United States, 48302
      • KCI at Mclaren Bloomfield Hills
    • Clarkston, Michigan, United States, 48346
      • KCI At McLaren Clarkston
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Flint, Michigan, United States, 48532
      • KCI at McLaren Flint
    • Lansing, Michigan, United States, 48910
      • KCI at McLaren Greater Lansing, Mid Michigan Physicians
    • Lapeer, Michigan, United States, 48446
      • KCI at McLaren Lapeer Region
    • Mount Clemens, Michigan, United States, 48043
      • KCI at McLaren Macomb
    • Mount Pleasant, Michigan, United States, 48858
      • KCI at McLaren Central Michigan
    • Petoskey, Michigan, United States, 49770
      • KCI at Northern Michigan
    • Port Huron, Michigan, United States, 48060
      • KCI at McLaren Port Huron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ancillary-Correlative (comprehensive genomic analysis); 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: laboratory biomarker analysis; Correlative studies; Other: cytology specimen collection procedure; Correlative studies; Other Names: cytologic sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1	Response rate will be estimated with 95% Wilson's CI.	Up to 2 years
Progression free survival (PFS)	PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.	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)	Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.	From date of registration to up to 2 years

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gerold Bepler, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimated): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2014-002 (Other Identifier: Barbara Ann Karmanos Cancer Institute); P30CA022453 (U.S. NIH Grant/Contract); NCI-2014-00913 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); W81XWH-11-1-0500 (Other Identifier: Dept of Defense)