Observational study on biomarker testing in lung cancer patients
Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
This study looks at how testing for specific markers in lung cancer can help patients get better treatment options and improve their care experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | US Oncology Research Industry-sponsored |
| Locations | 17 sites (Daphne, Alabama and 16 other locations) |
| Trial ID | NCT05885698 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a diverse patient population with early stage and advanced non-small cell lung cancer. It focuses on understanding how community-based management can improve patient convenience and reduce costs while maintaining clinical outcomes. The study will enroll treatment-naive patients and assess the impact of molecular testing on treatment choices, particularly in earlier stages of lung cancer. By identifying barriers to genomic testing, the study seeks to enhance adherence to national guidelines for tumor profiling.
Who should consider this trial
Good fit: Ideal candidates include adults with newly diagnosed early stage, locally advanced, or metastatic non-small cell lung cancer who are eligible for systemic therapy.
Not a fit: Patients with stage IA lung cancer or those with small cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to effective biomarker testing and targeted therapies for lung cancer patients, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies have shown success in improving outcomes through biomarker-guided therapies, but this approach in a community setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Daphne, Alabama and 16 other locations
- Southern Cancer Center, PC — Daphne, Alabama, United States (Recruiting)
- Arizona Oncology Associates, PC - NAHOA — Prescott Valley, Arizona, United States (Not_yet_recruiting)
- Rocky Mountain Cancer Center — Denver, Colorado, United States (Active_not_recruiting)
- Cancer Care Centers of Brevard, Inc. — Palm Bay, Florida, United States (Recruiting)
- Woodlands Medical Specialists, PA — Pensacola, Florida, United States (Active_not_recruiting)
- Affiliated Oncologists, LLC — Chicago Ridge, Illinois, United States (Recruiting)
- Illinois Cancer Specialists — Niles, Illinois, United States (Active_not_recruiting)
- Maryland Oncology Hematology, P.A. — Silver Spring, Maryland, United States (Active_not_recruiting)
- Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States (Active_not_recruiting)
- New York Oncology Hematology, P.C. — Albany, New York, United States (Recruiting)
- Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (Recruiting)
- Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States (Recruiting)
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States (Recruiting)
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (Active_not_recruiting)
- Virginia Oncology Associates — Newport News, Virginia, United States (Recruiting)
- Shenandoah Oncology, P.C. — Winchester, Virginia, United States (Active_not_recruiting)
- Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Makenzi C. Evangelist, MD — New York Oncology Hematology
- Study coordinator: Andrea Glidden, BSN, OCN
- Email: andrea.glidden@mckesson.com
- Phone: 630-728-5493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.