Carcinoma, Non-Small-Cell LungMYLUNGNCT05644808
MYLUNG Consortium Study Protocol 2
An observational study of Carcinoma, Non-Small-Cell Lung, run by US Oncology Research at 18 sites in United States.
Trial summary
This pragmatic 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
- 1,002 participants
- Where
- 18 sitesUnited States
- Study dates
- 29 Dec 2020to Dec 2027
- 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 pragmatic 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
- Eligible for systemic therapy based on the treating provider's assessment
- 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 may 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
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Texas Oncology - West Texas
Abilene, Texas, 79606
New York Oncology Hematology, P.C.
Albany, New York, 12208
Texas Oncology- DFWW
Arlington, Texas, 76012
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Southern Cancer Center, PC
Daphne, Alabama, 36526
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104
Texas Oncology-McAllen
McAllen, Texas, 78503
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Virginia Oncology Associates
Newport News, Virginia, 23606
Illinois Cancer Specialists
Niles, Illinois, 60714
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
Texas Oncology- Northeast Texas
Tyler, Texas, 75702
About this study
Official title: Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)
This pragmatic 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 pragmatic 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 will interrogate 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 (current trial) will prospectively evaluate 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 Protocol #3, which will evaluate the impact of these strategies on the patient journey as it relates to shared decision making.
- 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 Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death
- Comprehensive testing is defined as both PD-L1 testing to guide use of immunotherapies \& testing for all genomic alterations for which we have FDA-approved therapies incl EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS \& MET ii. Document whether patient receives single gene testing for actionable mutations compared to those who receive comprehensive testing. For patients who start systemic therapy prior to or without biomarker results, we will catalog reasons for not conducting testing incl:
- Clinical deterioration, clinical crisis
- Insufficient tissue
- Barriers to test ordering
- Tissue: obtaining sample, tissue retrieval
- Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), 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 (3)
Proportion of patients placed on biomarker-directed first treatment regimen vs those who were not
To determine the proportion of patients placed on biomarker-directed first treatment regimen. 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 ii. Misinterpretation of test results iii. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.) iv. Patient/provider attitudes and perceptions v. Financial barriers / Uncovered costs vi. Patient performance status
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
Determine the variance in biomarker test order practice patterns by community cancer clinic settings as measured by percentage of comprehensive testing ordered, type of test ordered, and resulting treatment assigned to the patient.
Characteristics of the cancer care practices include, but not limited to, number of geographic clinic locations, clinical settings (rural or urban), staffing and responsibilities, patient volumes, and Oncology Care Model (OCM) status.
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 posted9 Dec 2022
- Study start29 Dec 2020
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,002 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Makenzi Evangelist, MD, Principal investigator, New York Oncology Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644808
- Sponsor's protocol ID
- 20381
- Acronym
- MYLUNG
- Status last verified
- May 2026
- First submitted
- 30 Nov 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evangelist M, Wang B, Butrynski JE, Paschold J, Ward PJ, Waterhouse DM, Jotte RM, Ali K, Richards DA, Konduri K, Melnyk A, Owera RS, Hakimian D, Ghaddar H, Lander EM, Robert NJ, Yori JL, Upadhyay V, Spigel DR, Johnson ML. Biomarker Testing Rates and Patterns in Patients With Metastatic Non-Small Cell Lung Cancer: A Prospective, Observational Study in Community Practices. JCO Precis Oncol. 2026 Apr;10(4):e2500832. doi: 10.1200/PO-25-00832. Epub 2026 Apr 22.
PubMed 42018966
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 Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)
- ClinicalTrials.gov ID
- NCT05644808
- Acronym / sponsor ID
- MYLUNG / 20381
- 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
- Active, not recruiting
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2022 (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 pragmatic 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 pragmatic 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 will interrogate 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 (current trial) will prospectively evaluate 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 Protocol #3, which will evaluate the impact of these strategies on the patient journey as it relates to shared decision making.
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 pragmatic 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
- Eligible for systemic therapy based on the treating provider's assessment
- 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 may 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 Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death
Time frame: 5 years from date of enrollment into study
i. Comprehensive testing is defined as both PD-L1 testing to guide use of immunotherapies \& testing for all genomic alterations for which we have FDA-approved therapies incl EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS \& MET ii. Document whether patient receives single gene testing for actionable mutations compared to those who receive comprehensive testing. For patients who start systemic therapy prior to or without biomarker results, we will catalog reasons for not conducting testing incl: 1. Clinical deterioration, clinical crisis 2. Insufficient tissue 3. Barriers to test ordering 1. Tissue: obtaining sample, tissue retrieval 2. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), QA fail, test failure 3. Patient/provider attitudes \& perceptions 4. Provider knowledge about testing options 5. Patient knowledge about biomarker testing 6. Payor Coverage: prior authorization denial, payor refusal 7. Financial barriers: uncovered costs, reimbursement
3 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
Determine the variance in biomarker test order practice patterns by community cancer clinic settings as measured by percentage of comprehensive testing ordered, type of test ordered, and resulting treatment assigned to the patient.
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.
- Derived from this study: PubMed 42018966Evangelist M, Wang B, Butrynski JE, Paschold J, Ward PJ, Waterhouse DM, Jotte RM, Ali K, Richards DA, Konduri K, Melnyk A, Owera RS, Hakimian D, Ghaddar H, Lander EM, Robert NJ, Yori JL, Upadhyay V, Spigel DR, Johnson ML. Biomarker Testing Rates and Patterns in Patients With Metastatic Non-Small Cell Lung Cancer: A Prospective, Observational Study in Community Practices. JCO Precis Oncol. 2026 Apr;10(4):e2500832. doi: 10.1200/PO-25-00832. Epub 2026 Apr 22.
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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. This study is not recruiting at the moment.
Makenzi Evangelist, MD principal investigator
New York Oncology Hematology
18 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 18 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: under way, not looking for participants, 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 18 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death (time frame: 5 years from date of enrollment into study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644808, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 27 Oct 2026.