MYLUNG Consortium Part 3: Observational Study (MYLUNG)

May 30, 2023 updated by: US Oncology Research

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)

This longitudinal study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Lung cancer remains the most lethal malignancy in men and women in the U.S. Providing high quality management of these patients in the community setting as compared to hospital or academic centers offers the opportunity to reduce cost without sacrificing clinical outcome and simultaneously improving patient convenience and value. Many patients diagnosed with late-stage cancers can benefit from advanced biomarker testing, yet not all eligible patients receive this type of diagnostic testing today.

Within advanced non-small-cell lung cancer (aNSCLC), there are many specific somatic mutations observed in select patient populations that have targeted highly effective and less toxic therapies. National guidelines have advocated for broad tumor molecular profiling as a part of the standard diagnostic evaluation for aNSCLC, with the goal of identifying driver mutations for which effective therapies or clinical trials are available.

Furthermore, there is emerging evidence that molecular testing can impact treatment choices in earlier stages of lung cancer. However, adherence to genomic testing guidelines presents unique challenges to community oncologists. While most oncology clinical research has been conducted at well-established academic medical centers, over 85% of cancer patients are diagnosed and treated at local, community-based clinical practices. Barriers exist in the ability to order these tests efficiently, in a timely manner, and reimbursed accordingly. Furthermore, patient care can vary drastically based on community-associated disparities.

This longitudinal clinical trial will generate Real World Evidence (RWE) to validate efficacy of first treatment regimen in newly diagnosed patients with non-small cell lung cancer. The MYLUNG Program integrates three separate protocols: Protocol #1 interrogated historical data from a large number of practices seeing lung cancer patients to evaluate biomarker testing, decision making patterns, the patient journey, and the tissue journey; Protocol #2 prospectively evaluated the patient journey in a limited number of index practices focused on testing; integration of testing results; and treatments. Interventional strategies to optimize these objectives will be developed and integrated into various interventions all aimed at improving biomarker testing rates. Protocol #3 (22285) will serve as a resource to monitor the impact of these strategies on the patient journey as it relates to shared decision making, and will continue to prospectively evaluate the patient journey in a limited number of index practices focused on testing, integration of testing results and treatments.

Study Type

Observational

Enrollment (Estimated)

7500

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

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Recruiting
        • Southern Cancer Center, PC
        • Principal Investigator:
          • Michael Meshad, MD
        • Contact:
    • Arizona
      • Prescott Valley, Arizona, United States, 86314
        • Not yet recruiting
        • Arizona Oncology Associates, Pc - Nahoa
        • Contact:
        • Principal Investigator:
          • Allan V. Espinosa Morazan, MD
    • Colorado
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Rocky Mountain Cancer Center
    • Florida
      • Palm Bay, Florida, United States, 32901
        • Recruiting
        • Cancer Care Centers of Brevard, Inc.
        • Contact:
        • Principal Investigator:
          • Venkat Pavan R. Kancharla, MD
      • Pensacola, Florida, United States, 32503
        • Active, not recruiting
        • Woodlands Medical Specialists, PA
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Recruiting
        • Affiliated Oncologists, LLC
        • Contact:
        • Principal Investigator:
          • Rami Y. Haddad, MD
      • Niles, Illinois, United States, 60714
        • Active, not recruiting
        • Illinois Cancer Specialists
    • Maryland
      • Silver Spring, Maryland, United States, 20904
        • Active, not recruiting
        • Maryland Oncology Hematology, P.A.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Active, not recruiting
        • Minnesota Oncology Hematology, P.A.
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • New York Oncology Hematology, P.C.
        • Contact:
        • Principal Investigator:
          • Makenzi Evangelist, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Oncology Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • Patrick J. Ward, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center
        • Contact:
        • Principal Investigator:
          • James E. Butrynski, MD
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
        • Contact:
        • Principal Investigator:
          • Jerome H. Goldschmidt, Jr., MD
      • Fairfax, Virginia, United States, 22031
        • Active, not recruiting
        • Virginia Cancer Specialists, PC
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Virginia Oncology Associates
        • Contact:
        • Principal Investigator:
          • John C. Paschold, MD
      • Winchester, Virginia, United States, 22601
        • Active, not recruiting
        • Shenandoah Oncology, P.C.
    • Washington
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists, P.C.
        • Principal Investigator:
          • Anthony Van Ho, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This longitudinal study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment naive non-small cell lung cancer.

Description

Inclusion Criteria:

  • Adult subjects (18 years and older) with newly diagnosed early stage, locally advanced or metastatic non-small cell lung cancer
  • Must be eligible for systemic therapy based on the treating provider's assessment. If systemic therapy was recommended and documented by the treating provider but the patient declined, they can still be eligible for the study. Patients can be enrolled prior to start of treatment.
  • Subjects who developed locally advanced or metastatic disease after receiving adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of locally advanced or metastatic disease
  • Subjects must be enrolled within 30 days of initiation of systemic therapy
  • Signed informed consent

Exclusion Criteria:

  • Stage IA at the time of enrollment
  • Subjects with small cell lung cancer
  • Subjects with Unknown primary tumor origin

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

Cohorts and Interventions

Group / Cohort
Non-small Cell Lung Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing
Time Frame: 5 years from date of enrollment into study
Comprehensive biomarker testing is defined as both PD-L1 testing to guide the use of immunotherapies and testing for all genomic alterations for which there are FDA-approved therapies including (but not limited to) EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS and MET.
5 years from date of enrollment into study
For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing
Time Frame: 5 years from date of enrollment into study
  1. Clinical deterioration, clinical crisis
  2. Tissue: obtaining sample, tissue retrieval
  3. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (QA) fail, test failure
  4. Patient/provider attitudes & perceptions
  5. Provider knowledge about testing options
  6. Patient knowledge about biomarker testing
  7. Payor Coverage: prior authorization denial, payor refusal
  8. Financial barriers: uncovered costs, reimbursement
5 years from date of enrollment into study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time span between first systemic therapy as compared to date of initial presentation, date of diagnostic biopsy, date of first visit to a medical oncologist, and date of biomarker test order(s) and result(s).
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy
Time Frame: 5 years from date of enrollment into study

For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.

  1. Lack of availability or delays in obtaining targeted therapy
  2. Misinterpretation of test results
  3. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.)
  4. Patient/provider attitudes and perceptions
  5. Financial barriers / Uncovered costs
  6. Patient performance status
5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Staff per Practice
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Patient Volume per Practice
Time Frame: 5 years from date of enrollment into study
5 years from date of enrollment into study

Collaborators and Investigators

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

Sponsor

US Oncology Research

Investigators

  • Principal Investigator: Makenzi C. Evangelist, MD, New York Oncology Hematology
  • Principal Investigator: Patrick J. Ward, MD, Oncology Hematology Care Clinical Trials, LLC

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 (Actual)

January 30, 2023

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22285

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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