MYLUNG Consortium Study Protocol 2

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Proportion of Patients Who Do and Do Not Receive Biomarker Test Results Prior to Systemic Therapy or Death — 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

Trial sites (18)

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