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

August 10, 2023 updated by: Gerold Bepler, Barbara Ann Karmanos Cancer Institute

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gerold Bepler, M.D.
  • Phone Number: (313) 576-8665

Study Locations

  • United States
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Recruiting
        • KCI at McLaren Bay Region
        • Contact:
          • Phone Number: 800-527-6266
      • Bloomfield Hills, Michigan, United States, 48302
        • Active, not recruiting
        • KCI at Mclaren Bloomfield Hills
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • KCI At McLaren Clarkston
        • Contact:
          • Phone Number: 800-527-6266
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Gerold Bepler, M.D., PhD.
        • Sub-Investigator:
          • Hirva Mamdani, M.D.
        • Sub-Investigator:
          • Alicia Bolling-Fischer, M.D.
        • Sub-Investigator:
          • Jonathan D. Abramson, M.D.
        • Sub-Investigator:
          • Shalini Thoutreddy, M.D.
        • Sub-Investigator:
          • Samir Alsawah, M.D.
        • Sub-Investigator:
          • Maden Arora, M.D.
        • Sub-Investigator:
          • Sai Bikkina, M.D.
        • Sub-Investigator:
          • Rana Bilbeisi, M.D,
        • Sub-Investigator:
          • Aliccia Bollig-Fischer, M.D.
        • Sub-Investigator:
          • Elena Coppola, M.D.
        • Sub-Investigator:
          • Salman Fateh, M.D.
        • Sub-Investigator:
          • Sandeep Grewal, M.D.
        • Sub-Investigator:
          • Youssef Hanna, M.D.
        • Sub-Investigator:
          • Christian Hyde, M.D.
        • Sub-Investigator:
          • Frank Knechtl, M.D.
        • Sub-Investigator:
          • Cheryl Kovalski, M.D.
        • Sub-Investigator:
          • Elizabeth Layhe, M.D.
        • Sub-Investigator:
          • Stephanie Leslie, M.D.
        • Sub-Investigator:
          • Sharon Levandowski, M.D.
        • Sub-Investigator:
          • Mohammed Masri, M.D.
        • Sub-Investigator:
          • Seraphim Pallas, M.D.
        • Sub-Investigator:
          • Trevor Singh, M.D.
        • Sub-Investigator:
          • David Eilender, M.D.
        • Sub-Investigator:
          • Anteneh Tesfaye, M.D.
        • Sub-Investigator:
          • Ammar Sukari, M.D.
        • Sub-Investigator:
          • Ronald Kauwachi, M.D.
        • Sub-Investigator:
          • Faheem Ahmed, M.D.
        • Sub-Investigator:
          • Usha Sree Chamarthy, M.D.
        • Sub-Investigator:
          • Haitham Al-Okk, M.D.
        • Sub-Investigator:
          • Anup Lal, M.D.
        • Sub-Investigator:
          • Dipesh Uprety, M.D.
        • Sub-Investigator:
          • Brooke Spencer (Trotter), M.D.
        • Sub-Investigator:
          • Numan Fateh, M.D.
        • Sub-Investigator:
          • Borys Hrinczenko, M.D.
        • Sub-Investigator:
          • Daniel Isaac, D.O.
        • Sub-Investigator:
          • Jatin Rana, M.D.
        • Sub-Investigator:
          • Ashley Matusz-Fisher, M.D.
        • Sub-Investigator:
          • Faras Alsawah, M.D.
      • Flint, Michigan, United States, 48532
        • Recruiting
        • KCI at McLaren Flint
        • Contact:
          • Phone Number: 800-527-6266
      • Lapeer, Michigan, United States, 48446
        • Recruiting
        • KCI at McLaren Lapeer Region
        • Contact:
          • Phone Number: 800-527-6266
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • KCI at McLaren Macomb
        • Contact:
          • Phone Number: 800-527-6266
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • KCI at McLaren Central Michigan
        • Contact:
          • Phone Number: 800-527-6266
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • KCI at Northern Michigan Petoskey
        • Contact:
          • Phone Number: 800-527-6266
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • KCI at McLaren Port Huron
        • Contact:
          • Phone Number: 800-527-6266

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 21 days
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
Time Frame: Up to 2 years
Response rate will be estimated with 95% Wilson's CI.
Up to 2 years
Progression free survival (PFS)
Time Frame: 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
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)
Time Frame: From date of registration to up to 2 years
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

This is where you will find people and organizations involved with this study.

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

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 Major Dates

Study Start

June 1, 2014

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

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)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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