LUNGevity Foundation

Small-cell lung cancer (SCLC) is associated with poor survival and is accompanied by symptoms that impact patients' quality of life. Although quality of life can be assessed by the EORTC 30-item core questionnaire (QLQ-C30) and 13-item lung cancer (QLQ-LC13) module, interpretation of meaningful improvement or deterioration within and between individuals is challenging. The objective of this study was to derive thresholds for interpretation of changes over time for the key scales of Coughing, Chest Pain, Dyspnea, Physical Functioning, and Global Health Status (GHS). Anchor- and distribution-based analyses were used to derive meaningful within-patient change (MWPC) and meaningful between-group difference (MBGD) thresholds using data from the phase II DeLLphi-301 trial in patients with previously treated SCLC. Methods included estimating mean change scores, mixed models for repeated measures, classification statistics, receiver operating characteristic curves, alongside calculating half standard deviation and standard error of measurement. MWPC recommendations were ±33.3 for single-item scales QLQ-LC13 Chest Pain and Coughing, ±16.7 for both QLQ-LC13 Dyspnea and QLQ-C30 GHS, and ±20.0 for QLQ-C30 Physical Functioning. Estimated MBGD thresholds ranged from ±6 for GHS to ±22 for Coughing. To our knowledge, this study is the first to estimate MWPC and MBGD thresholds specifically in patients with relapsed SCLC. Estimated threshold ranges are considered robust given the comprehensive considerations and triangulation of various methods and can help clinicians, researchers, and healthcare decision makers to evaluate the clinical meaningfulness to patients of changes in key SCLC scales over time.

51 Background: Timely biomarker testing is essential for guiding treatment in non–small cell lung cancer (NSCLC). Reflex biomarker testing, ordered by pathologists, integrates biomarkers into the diagnostic process. However, CMS policies, particularly the 14-Day Rule and lack of clarity on ordering authority, limit the use of reflex testing, disrupting standardized workflows and delaying care. This study explores how these policies affect cancer care delivery. Methods: In early 2025, LUNGevity Foundation, with the Association for Molecular Pathology and the American Society for Clinical Pathology, surveyed 115 healthcare professionals to determine the prevalence of standardized workflows, pathologist-ordered biomarker testing, and application of the 14-Day Rule. Results: Findings indicate strong support for pathologist-ordered biomarker testing for reflex testing and timely diagnosis. Most respondents (94%) agreed CMS should recognize pathologists as ordering physicians, with 49% preferring this recognition be provided through guidelines. The majority (74%) strongly agreed this change would improve patient care. Standardized protocols - especially with in-house testing - were more common when pathologists ordered biomarker testing. Yet at 42% of sites using or considering such protocols, pathologists were not the ordering physician. Among these, 57% wanted implementation guidance, and 46% sought regulatory or compliance clarity for how to implement pathologist-initiated testing. Application of the 14-Day Rule varied: 22% applied it to inpatients, 13% to both inpatients and outpatients, and 23% were unsure. Regardless, 78% of those applying the 14-Day Rule said it caused treatment delays, and 40% reported treatment was selected before results were received. When asked how costs of multi-gene panels for in-patients with advanced-stage cancer are managed, 30% of respondents said the laboratory absorbs the cost, and 39% were unsure. Conclusions: Hospitals face the challenge of navigating regulations that impact care delivery - particularly the 14-Day Rule and unclear policies on pathologists' role in ordering biomarker panels, which influence implementation of reflex biomarker testing in the NSCLC diagnostic process. Respondents strongly supported pathologist-ordered testing as essential for reflex workflows and improved patient care. The 14-Day Rule was cited as a barrier to timely treatment, and a cause of financial strain when hospitals bypass the policy to expedite testing. Many were uncertain how testing costs are managed under current constraints, highlighting the need for clearer institutional policies. Hospital administrators should assess the impact of these regulations on care delivery and consider workflow adjustments in collaboration with pathology and oncology. Further research will gather broader input to guide recommendations to CMS, pathologists, and oncologists.

585 Background: Digital navigation platforms offer unique insights into how cancer patients seek information about their disease. Understanding these behaviors can inform the development of tailored educational resources and support services. This study examines the information-seeking patterns of patients with metastatic breast cancer (mBC) and metastatic non-small cell lung cancer (mNSCLC) using the Manta Cares digital platform. Methods: We analyzed early usage data from the Manta Cares platform, which uses a subway map structure with evidence-based disease-specific information available at each station throughout the patient clinical course. Users were recruited via patient advocacy groups, word-of-mouth, meeting presentations and social media. They provided an email, age range and cancer type information. No other personal identifying data was provided or retained. User entries were de-identified prior to analysis. While maps for early breast cancer, mBC & mNSCLC were available, this abstract focuses on the engagement patterns for metastatic patients. Results: The first 99 platform users included patient (82), care partners (3) and navigators (14). Of patients 16 self-identified as having mBC and 18 with mNSCLC. Both had similar age distribution (40-69 years). Corresponding activity for mBC and mNSCLC are shown in the table, with a total of 1,287 visits across 471 stations. There were different information-seeking behaviors between the two groups. mBC patients focused on evaluative processes (treatment assessment, disease progression) with emotional management. mNSCLC patients showed diagnostic/biomarker-oriented interest, emphasizing testing, specific treatments, and physical management. Conclusions: mBC and mNSCLC patients had different information-seeking interests. mBC patients sought treatment information and emotional support, while mNSCLC patients prioritized clinical and diagnostic content. Digital tools should be tailored to disease specific groups: emotional support alongside treatment information for mBC patients, and clinical information with . Further analyses needed to analyze engagement between early & metastatic populations. Understanding these differences can guide more effective digital resources for specific cancer patient groups. Funding: Gilead Sciences, Inc. & Manta Cares Inc. mBC & mNSCLC patient engagement. Patients mBC (n=16) mNSCLC (n=18) Overall Engagement 448 visits, 175 stations 839 visits, 296 stations Content Focus (% of Visits: Station Descriptions) Diagnosis 20%: Treatment options, Appointments, New findings 28%: Biomarker testing,NSCLC subtyping Treatment 58%: Chemotherapy options, Cancer types, Targetable mutations 42%: Therapy selection, Spread Living with cancer 22%: Understand prognosis, Living with mBC, Managing emotions 30%: Weight management, Overall well-being

8541 Background: Biomarker testing is essential to optimize lung cancer (LC) care, yet uptake of testing is suboptimal due to lack of access, cost, and long turnaround times (TAT). Recent advances now require biomarker testing in early-stage LC. In 2024, the International Association for the Study of Lung Cancer (IASLC) launched a 2 nd global survey to measure improvements and barriers to implementation of testing. We compared results from North America (NA) with global results by high income (HIC) and low or middle income countries (LMIC). Methods: A multi-disciplinary committee of oncologists, pathologists, pulmonologists, epidemiologists, and advocacy partners created the survey. We used mixed methods, with focus groups and in-depth interviews informing the quantitative survey with IRB oversite. Chi-square tests were utilized to compare frequencies between NA v Other HIC (OHIC) and HIC v LMIC. Results: Of the 1677 responses globally, 1501 were from HIC and 176 from LMIC. HIC included 337 responses from NA (287 United States and 50 Canada). Nearly all NA respondents (99%) believe biomarker testing significantly impacts patient outcomes and 94% report a clear understanding of who should be tested (v 91% OHIC, p=0.09). In NA, 66% and 40% ranked biomarker testing as highly important in late- and early- stage LC, respectively (64% and 28% OHIC, p=0.68 and p<0.01). Only 45% of NA respondents were satisfied with biomarker testing conditions (v 52% OHIC, p=0.03), and 69% estimate at least half of LC patients receive biomarker testing (71% OHIC), an increase from 45% in the 2018 survey (p<0.01). We found 40% of respondents from NA sometimes or often began treatment prior to obtaining biomarker results (41% OHIC). Key barriers identified were cost (23%), time (22%), and sample quality (20%), consistent with global and OHIC trends. Mean TAT in NA was 17.1 days (SD 7.8) v 16.1 days (SD 9.0) in HIC. Insufficient tumor was the primary cause for re-biopsy in late and early-stage patients for NA (58%) and HIC (48%). Lastly, 14% of NA reported no additional training in next-generation sequencing beyond medical education (16% OHIC). Globally, conditions were worse in LMIC v HIC including those who sometimes or often begin treatment prior to obtaining biomarker results (73% v 41%, p<0.01) and those who are confident or extremely confident in the adequacy of testing at their institution (48% v 68%, p<0.01). Conclusions: Respondents from NA believe they understand the value of biomarker testing for LC and who should be tested. Testing practices have reportedly improved since 2018, yet less than half of NA respondents are satisfied with biomarker testing practices and many patients are still treated without biomarker information. Responses from NA were similar to OHIC, with some exceptions, but significant disparities were evident in LMIC. We identified key barriers that should be addressed to optimize testing practices and patient outcomes.

Patient-reported outcomes are critical for assessing symptomatic adverse events in non-small-cell lung cancer (NSCLC) clinical trials, but these reports may not fully capture tyrosine kinase inhibitor-specific adverse events in patients with metastatic NSCLC. This study evaluated coverage of tyrosine kinase inhibitor-related symptomatic adverse events by commonly used patient-reported outcomes item libraries. We compiled a list of US Food and Drug Administration-approved tyrosine kinase inhibitors for NSCLC with alterations in EGFR, ALK, ROS1, RET, MET, and NTRK. Symptomatic adverse events were extracted from clinical trials reported in US prescribing information (ie, drug labels). The European Organisation for Research and Treatment of Cancer (EORTC), Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item libraries were searched for items corresponding to extracted adverse events. Items were classified according to the adverse event's physical, functional, and social or emotional impact. Data from 17 drug labels covering 29 clinical trials of 17 tyrosine kinase inhibitors were analyzed. By tyrosine kinase inhibitor, EORTC covered the highest average percentage of adverse events (99%), followed by PRO-CTCAE (86%) and PROMIS (47%). Of the 15 most common adverse events, 8 were covered by all 3 item libraries. The EORTC and PRO-CTCAE covered 15 adverse events, whereas PROMIS covered 8. Of the 8 adverse events covered by all 3 libraries, PROMIS included the most items assessing functional and social or emotional impact. The EORTC and PRO-CTCAE covered more symptomatic adverse events than PROMIS. For the adverse events it covered, PROMIS had the most items assessing functional and social or emotional impact. Our assessment is a starting point for improving patient-reported outcome coverage of adverse events associated with new treatments such as tyrosine kinase inhibitors.

78 Background: The Rural Appalachian Lung Cancer Screening Initiative is led by the Association of Cancer Care Centers (ACCC) and patient advocacy partners. Recognized by the White House Cancer Moonshot, this initiative seeks to improve lung cancer screening rates by partnering with health systems in rural Appalachia to develop and implement interventions. An 11-county region bordering West Virginia, Virginia, and Kentucky has significantly higher mortality and lung cancer incidence rates than the national rates of 35.0 and 54.0 per 100,000 people, respectively (Table 1). This region was identified as the focus area for the initiative with participation from health systems in Pike County, KY, and Buchanan County, VA. Methods: To understand availability of local resources, ACCC developed an interactive GIS tool that identifies screening and referral locations as well as essential services in the region. Lung cancer screening sites, oncology services, mammography locations, critical access hospitals, NCI-designated cancer centers, federally qualified health centers (FQHCs) and look-alikes, rural health clinics, and primary care/general health services were identified from publicly available data and data requested from state departments of health. Facilities were contacted to verify services when unclear. STATA 18 was used to combine and clean data for upload to Google MyMaps, creating an interactive map. Results: Of the 11 counties, all contain at least 1 FQHC or primary care site. However, 5 of the counties do not have lung cancer screening sites and 7 of the counties do not have oncology service sites (Table). The closest NCI-designated cancer centers to the participating sites are over 140 miles away. Conclusions: While there is a notable presence of primary care, access to lung cancer screening and oncology care is limited. Sites can utilize this map to inform development of interventions by considering potential geographical challenges, identifying referral sites, outreach opportunities, and partners to facilitate lung cancer screening and education. Further, these methods are replicable, and can be used to inform current access to care and improve equitable delivery of lung cancer screening in regions across the U.S. Distribution of lung cancer mortality, incidence, and infrastructure within initiative focus region. Region Mortality*(per 100,000) Incidence*(per 100,000) # Lung Cancer Screening Sites # Oncology Services Sites KY (1 county) 70 109.3 2 2 VA (6 counties) 45.0 – 61.4 42.9 – 68.6 4 3 WV (4 counties) 57.6 – 74.8 100.4 – 111.5 1 0 *Lung & Bronchus, 2016-2020 age-adjusted death rates (KY, VA, WV) and incidence rates (KY, WV). Lung & Bronchus, 2015-2019 age-adjusted incidence rate (VA). Source: statecancerprofiles.cancer.gov.