Biomarker Testing Rates and Patterns in Patients With Metastatic Non–Small Cell Lung Cancer: A Prospective, Observational Study in Community Practices

PURPOSE As targeted therapies are associated with improved outcomes in patients with non–small cell lung cancer (NSCLC) with genetic alterations, biomarker testing is recommended to identify actionable alterations (AAs). Here, we report findings on biomarker testing in the subset of patients with metastatic (m)NSCLC from the Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium Protocol 2 study. METHODS In this prospective, noninterventional, observational study, patients 18 years and older with NSCLC (excluding stage IA) were enrolled from 18 community practices in the United States from 2020 to 2022 (ClinicalTrials.gov identifier: NCT05644808 ). Biomarker testing rates relative to timing of first-line (1L) therapy initiation, testing modalities, AAs, 1L therapies, next-generation sequencing (NGS) characteristics, and survival outcomes were examined. In addition, testing rates were compared with our previous retrospective analysis (Protocol 1). RESULTS Among 556 patients with mNSCLC, 98.8% received testing for ≥1 biomarker at any time and 79.0% received ≥1 test result before initiating 1L therapy (versus 89.9% and 79.2%, respectively, in Protocol 1 2018-2020); 72.8% and 55.6% of patients received NGS testing and NGS results before 1L therapy, respectively (versus 37.0% and 5.0%, respectively, in Protocol 1); 63.5% and 44.1% of patients received guideline-compliant (8-gene) testing and 8-gene test results, respectively, before 1L therapy. Among patients who received biomarker test results before 1L therapy and had an AA (n = 94), 77.7% (n = 73) received 1L-targeted therapy. Survival outcomes trended favorably in these patients. CONCLUSION Although guideline-compliant (8-gene) and NGS testing rates fall short of recommended guidelines, several improvements in testing rates from Protocol 1 were observed. In addition, almost 80% of patients, who received test results before 1L therapy and had an AA, received 1L targeted therapy. Improved survival outcomes in these patients highlight the importance of effective follow-through from testing to treatment.