MYLUNG Consortium Part 3: Observational Study

Sponsor

US Oncology Research (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05885698

Collaborator

(none)

7,500

Enrollment

Locations

Anticipated Duration (Months)

441.2

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

7500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Non-small Cell Lung Cancer

Outcome Measures

Primary Outcome Measures

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 [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.
For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing [5 years from date of enrollment into study]
Clinical deterioration, clinical crisis Tissue: obtaining sample, tissue retrieval Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (QA) fail, test failure Patient/provider attitudes & perceptions Provider knowledge about testing options Patient knowledge about biomarker testing Payor Coverage: prior authorization denial, payor refusal Financial barriers: uncovered costs, reimbursement

Secondary Outcome Measures

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 have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy. Lack of availability or delays in obtaining targeted therapy Misinterpretation of test results Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.) Patient/provider attitudes and perceptions Financial barriers / Uncovered costs Patient performance status
For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned [5 years from date of enrollment into study]
Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice [5 years from date of enrollment into study]
Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice [5 years from date of enrollment into study]
Characteristics of Cancer Care Practices: Number of Staff per Practice [5 years from date of enrollment into study]
Characteristics of Cancer Care Practices: Patient Volume per Practice [5 years from date of enrollment into study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Cancer Center, PC	Daphne	Alabama	United States	36526
2	Arizona Oncology Associates, PC - NAHOA	Prescott Valley	Arizona	United States	86314
3	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
4	Cancer Care Centers of Brevard, Inc.	Palm Bay	Florida	United States	32901
5	Woodlands Medical Specialists, PA	Pensacola	Florida	United States	32503
6	Affiliated Oncologists, LLC	Chicago Ridge	Illinois	United States	60415
7	Illinois Cancer Specialists	Niles	Illinois	United States	60714
8	Maryland Oncology Hematology, P.A.	Silver Spring	Maryland	United States	20904
9	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
10	New York Oncology Hematology, P.C.	Albany	New York	United States	12208
11	Oncology Hematology Care Clinical Trials, LLC	Cincinnati	Ohio	United States	45242
12	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	United States	97401
13	Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Blacksburg	Virginia	United States	24060
14	Virginia Cancer Specialists, PC	Fairfax	Virginia	United States	22031
15	Virginia Oncology Associates	Newport News	Virginia	United States	23606
16	Shenandoah Oncology, P.C.	Winchester	Virginia	United States	22601
17	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98684

Sponsors and Collaborators

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