Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
Summary
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.
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.
Arms & interventions
Outcome measures
Primary
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
Time frame: 5 years from date of enrollment into study
Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing
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.
Time frame: 5 years from date of enrollment into study
For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing
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
Time frame: 5 years from date of enrollment into study
Secondary
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
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
For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered
Time frame: 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 Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned
Time frame: 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
Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice
Time frame: 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
Characteristics of Cancer Care Practices: Patient Volume per Practice
Time frame: 5 years from date of enrollment into study
Eligibility criteria
Study locations (17)
Southern Cancer Center, PC
Daphne, Alabama, 36526
Arizona Oncology Associates, PC - NAHOA
Prescott Valley, Arizona, 86314
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415
Illinois Cancer Specialists
Niles, Illinois, 60714
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
New York Oncology Hematology, P.C.
Albany, New York, 12208
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Virginia Oncology Associates
Newport News, Virginia, 23606
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684