Carcinoma, Non-Small-Cell LungMYLUNGNCT05885698
MYLUNG Consortium Part 3: Observational Study
An observational study of Carcinoma, Non-Small-Cell Lung, run by US Oncology Research at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 7,500 participants
- Where
- 17 sitesUnited States
- Study dates
- 30 Jan 2023to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Stage IA at the time of enrollment
- Subjects with small cell lung cancer
- Subjects with Unknown primary tumor origin
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 10 recruiting
- Recruiting
New York Oncology Hematology, P.C.
Albany, New York, 12208
Ambri Cicchinelli, 518-262-6696, ambri.cicchinelli@usoncology.com
Makenzi Evangelist, MD
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Natasha R. Holt, 540-982-0237, natasha.holt@usoncology.com
Jerome H. Goldschmidt, Jr., MD
- Recruiting
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415
Angela Malone, 708-424-9710, Angela.Malone@usoncology.com
Rami Y. Haddad, MD
- Recruiting
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Sara Gonce, 513-751-2273, Sara.Gonce@usoncology.com
Patrick J. Ward, MD
- Recruiting
Southern Cancer Center, PC
Daphne, Alabama, 36526
Karla Childers, 251-433-9899, karla.childers@usoncology.com
Michael Meshad, MD
- Active, not recruiting
Rocky Mountain Cancer Center
Denver, Colorado, 80218
- Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Jeanne Schaffer, 541-683-5001, jeanne.schaffer@usoncology.com
James E. Butrynski, MD
- Active, not recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
- Active, not recruiting
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
- Recruiting
Virginia Oncology Associates
Newport News, Virginia, 23606
Ebony Villarson, 757-873-9810, ebony.villarson@usoncology.com
John C. Paschold, MD
- Active, not recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
- Recruiting
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901
Karla Childers, 251-433-9899, karla.childers@usoncology.com
Venkat Pavan R. Kancharla, MD
- Active, not recruiting
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503
- Not yet recruiting
Arizona Oncology Associates, PC - NAHOA
Prescott Valley, Arizona, 86314
Erika Arguello Vargas, 928-775-9430, erika.arguellovargas@usoncology.com
Allan V. Espinosa Morazan, MD
- Active, not recruiting
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
- Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Julian Kern, 360-597-1300, julian.kern@usoncology.com
Anthony Van Ho, MD
- Active, not recruiting
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
About this study
Official title: Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Lung Cancer, Squamous Non-small Cell Lung Cancer, Non-squamous Non-small Cell Lung Cancer, Biomarker Testing, Tumor Tissue Testing
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-small Cell Lung Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
Measured: 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.
Measured: 5 years from date of enrollment into study
For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing
- 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
Measured: 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
Measured: 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).
Measured: 5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered
Measured: 5 years from date of enrollment into study
For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy
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
Measured: 5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned
Measured: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice
Measured: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice
Measured: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Staff per Practice
Measured: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Patient Volume per Practice
Measured: 5 years from date of enrollment into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start30 Jan 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Makenzi C. Evangelist, MD, Principal investigator, New York Oncology HematologyPatrick J. Ward, MD, Principal investigator, Oncology Hematology Care Clinical Trials, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885698
- Sponsor's protocol ID
- 22285
- Acronym
- MYLUNG
- Status last verified
- May 2026
- First submitted
- 22 Feb 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)
- ClinicalTrials.gov ID
- NCT05885698
- Acronym / sponsor ID
- MYLUNG / 22285
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Lung Cancer, Squamous Non-small Cell Lung Cancer, Non-squamous Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-small Cell Lung Cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Stage IA at the time of enrollment
- Subjects with small cell lung cancer
- Subjects with Unknown primary tumor origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death
Time frame: 5 years from date of enrollment into study
Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing
Time frame: 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
Time frame: 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
9 secondary outcomes
Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
Time frame: 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).
Time frame: 5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Test Ordered
Time frame: 5 years from date of enrollment into study
For Patients without Biomarker-Directed First Treatment Regimen, Catalog Reasons for Not Prescribing Biomarker-Targeted Therapy
Time frame: 5 years from date of enrollment into study
For Patients who Receive Comprehensive Biomarker Testing, list Types of Resulting Treatment Regimen Assigned
Time frame: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Geographic Clinical Locations Per Practice
Time frame: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Rural Setting vs Urban Setting at each Practice
Time frame: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Number of Staff per Practice
Time frame: 5 years from date of enrollment into study
Characteristics of Cancer Care Practices: Patient Volume per Practice
Time frame: 5 years from date of enrollment into study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Makenzi C. Evangelist, MD principal investigator
New York Oncology Hematology
Patrick J. Ward, MD principal investigator
Oncology Hematology Care Clinical Trials, LLC
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by US Oncology Research at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Glidden, BSN, OCN (630-728-5493, andrea.glidden@mckesson.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death (time frame: 5 years from date of enrollment into study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.