MYLUNG Consortium Part 3: Observational Study
MYLUNG
Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
1 other identifier
observational
7,500
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
17 active sites
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 Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
July 18, 2024
July 1, 2024
7.8 years
February 22, 2023
July 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
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.
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
5 years from date of enrollment into study
Secondary Outcomes (9)
Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
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).
5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered
5 years from date of enrollment into study
For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy
5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned
5 years from date of enrollment into study
- +4 more secondary outcomes
Study Arms (1)
Non-small Cell Lung Cancer
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Stage IA at the time of enrollment
- Subjects with small cell lung cancer
- Subjects with Unknown primary tumor origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Southern Cancer Center, PC
Daphne, Alabama, 36526, United States
Arizona Oncology Associates, PC - NAHOA
Prescott Valley, Arizona, 86314, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Makenzi C. Evangelist, MD
New York Oncology Hematology
- PRINCIPAL INVESTIGATOR
Patrick J. Ward, MD
Oncology Hematology Care Clinical Trials, LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2023
First Posted
June 2, 2023
Study Start
January 30, 2023
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
July 18, 2024
Record last verified: 2024-07