MYLUNG Consortium Part 3: Observational Study

NCT05885698 · tracked via the Priya Life Science USA tracker

Sponsor

US Oncology Research

Phase

Observational

Started

2023-01-30

Last updated

2026-05-18

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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
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

Trial sites (17)

Facility	City	Region	Status
Southern Cancer Center, PC	Daphne	Alabama	Recruiting
Arizona Oncology Associates, PC - NAHOA	Prescott Valley	Arizona	Not Yet Recruiting
Rocky Mountain Cancer Center	Denver	Colorado	Active Not Recruiting
Cancer Care Centers of Brevard, Inc.	Palm Bay	Florida	Recruiting
Woodlands Medical Specialists, PA	Pensacola	Florida	Active Not Recruiting
Affiliated Oncologists, LLC	Chicago Ridge	Illinois	Recruiting
Illinois Cancer Specialists	Niles	Illinois	Active Not Recruiting
Maryland Oncology Hematology, P.A.	Silver Spring	Maryland	Active Not Recruiting
Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	Active Not Recruiting
New York Oncology Hematology, P.C.	Albany	New York	Recruiting
Oncology Hematology Care Clinical Trials, LLC	Cincinnati	Ohio	Recruiting
Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Blacksburg	Virginia	Recruiting
Virginia Cancer Specialists, PC	Fairfax	Virginia	Active Not Recruiting
Virginia Oncology Associates	Newport News	Virginia	Recruiting
Shenandoah Oncology, P.C.	Winchester	Virginia	Active Not Recruiting
Northwest Cancer Specialists, P.C.	Vancouver	Washington	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05885698 on ClinicalTrials.gov ↗ ← All trials in the USA