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Observational Study for Non-Small Cell Lung Cancer

This study, called MYLUNG Consortium Part 3, is an observational study for people with newly diagnosed non-small cell lung cancer. It aims to understand how biomarker testing (tests that look for specific changes in cancer cells) is used in community settings before patients start treatment. Researchers want to see how quickly these tests are done, what challenges prevent testing, and how biomarker-guided treatment affects patient outcomes. The study will follow about 7500 participants over five years to gather this information. This study does not involve any specific interventions or treatments.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to enroll about 7500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years from the date they join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05885698

MYLUNG Consortium Part 3: Observational Study

Recruiting
Not specifiedAges 18+Observational
US Oncology Research
~7,500 participants
Updated 2026-05-18 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
Measured over 5 years from date of enrollment into study
+2 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

17 sites across 12 states
Virginia4
Florida2
Illinois2
Alabama1
Arizona1
Colorado1
Maryland1
Minnesota1

Study leadership

  • Makenzi C. Evangelist, MD · PRINCIPAL_INVESTIGATOR · New York Oncology Hematology
  • Patrick J. Ward, MD · PRINCIPAL_INVESTIGATOR · Oncology Hematology Care Clinical Trials, LLC

Who to contact

Andrea Glidden, BSN, OCN
[email protected]
630-728-5493
Email the study team

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Eligibility criteria

Inclusion

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

Stage IA at the time of enrollment
Subjects with small cell lung cancer
Subjects with Unknown primary tumor origin

What this trial measures

  • Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death5 years from date of enrollment into study
  • Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing5 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 Testing5 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