MYLUNG Consortium Part 3: Observational Study

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.

• 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]