Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Makenzi Evangelist, MD

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.

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.

MYLUNG Consortium Study Protocol 2

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)

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

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.

i. 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

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.

US Oncology Research

Andrea Glidden, BSN, OCN

Taqi Mohammad

Karla Childers

Michael Meshad, MD

Erika Arguello Vargas

Allan V. Espinosa Morazan, MD

Venkat Pavan R. Kancharla, MD

Angela Malone

Rami Y. Haddad, MD

Ambri Cicchinelli

Sara Gonce

Patrick J. Ward, MD

Jeanne Schaffer

James E. Butrynski, MD

Natasha R. Holt

Jerome H. Goldschmidt, Jr., MD

Ebony Villarson

John C. Paschold, MD

Julian Kern

Anthony Van Ho, MD

Makenzi C. Evangelist, MD

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.

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.

MYLUNG Consortium Part 3: Observational Study

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational 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.

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

For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.

1. Lack of availability or delays in obtaining targeted therapy
2. Misinterpretation of test results
3. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.)
4. Patient/provider attitudes and perceptions
5. Financial barriers / Uncovered costs
6. Patient performance status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MYLUNG Consortium Study Protocol 2	NCT05644808	Carcinoma, Non-...		18 Years -	US Oncology Research
MYLUNG Consortium Part 3: Observational Study	NCT05885698	Carcinoma, Non-...		18 Years -	US Oncology Research

Spots Global Cancer Trial Database for tumor tissue testing