SHEDDING LIGHT ON PATIENT-REPORTED OUTCOME MEASURE UTILIZATION ACROSS NSCLC THERAPIES
Author(s)
Trupti Dhumal, MS, PhD1, Sahil Bhave, MS1, Emma A. van Eijndhoven, MSc, MA2, Ambarish J. Ambegaonkar, PhD1;
1APPERTURE LLC, Marlboro, NJ, USA, 2APPERTURE LLC, Los Angeles, CA, USA
1APPERTURE LLC, Marlboro, NJ, USA, 2APPERTURE LLC, Los Angeles, CA, USA
OBJECTIVES: As oncology care shifts towards patient-centered decision-making, patient reported outcomes (PRO) are increasingly collected in clinical trials, yet their application remains inconsistent. This study characterized the use of PRO measures across drug classes in NSCLC trials.
METHODS: We analyzed PRO measure use and their associated trends for both ongoing and completed US-based, industry-sponsored NSCLC clinical trials between 2015-2025. Trials were identified from ClinicalTrials.gov and categorized by drug class and therapy type (monotherapy vs combination). PRO inclusion, endpoint designation, and PRO domains were summarized descriptively.
RESULTS: Among 864 NSCLC clinical trials, 108 (12.5%) included PRO measures, exclusively as exploratory or secondary endpoints. Majority of PRO-inclusive trials were ongoing (n=85, 78.7%), with the remainder being completed (n= 23, 21.2%). PRO instrument selection varied by drug class. Within monotherapies, disease-specific quality-of-life (QOL) measures, particularly EORTC QLQ-C30 (n=11) and EORTC QLQ-LC13 (n=8), were frequently used in trials of ALK inhibitors (e.g., alectinib), PD-L1 inhibitors (e.g., atezolizumab, durvalumab), and PD-1 inhibitors (e.g., nivolumab, and pembrolizumab). Tyrosine kinase inhibitors (e.g., zongertinib, entrectinib) combined disease-specific EORTC QLQ-C30 and generic QOL instruments, such as EQ-5D (n= 4). In contrast, TIGIT inhibitors (e.g. rilvegostomig) and antibody-drug conjugates (e.g. dato-DXd) predominantly utilize PROMIS, which assesses general health and physical and mental functioning rather than QOL (n= 4).
CONCLUSIONS: PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. Substantial heterogeneity in PRO instrument selection suggests a lack of standardization and limits the interpretability and downstream value of PRO evidence. Greater alignment in PRO selection may enhance relevance to regulatory, payer, and clinical decision-making.
METHODS: We analyzed PRO measure use and their associated trends for both ongoing and completed US-based, industry-sponsored NSCLC clinical trials between 2015-2025. Trials were identified from ClinicalTrials.gov and categorized by drug class and therapy type (monotherapy vs combination). PRO inclusion, endpoint designation, and PRO domains were summarized descriptively.
RESULTS: Among 864 NSCLC clinical trials, 108 (12.5%) included PRO measures, exclusively as exploratory or secondary endpoints. Majority of PRO-inclusive trials were ongoing (n=85, 78.7%), with the remainder being completed (n= 23, 21.2%). PRO instrument selection varied by drug class. Within monotherapies, disease-specific quality-of-life (QOL) measures, particularly EORTC QLQ-C30 (n=11) and EORTC QLQ-LC13 (n=8), were frequently used in trials of ALK inhibitors (e.g., alectinib), PD-L1 inhibitors (e.g., atezolizumab, durvalumab), and PD-1 inhibitors (e.g., nivolumab, and pembrolizumab). Tyrosine kinase inhibitors (e.g., zongertinib, entrectinib) combined disease-specific EORTC QLQ-C30 and generic QOL instruments, such as EQ-5D (n= 4). In contrast, TIGIT inhibitors (e.g. rilvegostomig) and antibody-drug conjugates (e.g. dato-DXd) predominantly utilize PROMIS, which assesses general health and physical and mental functioning rather than QOL (n= 4).
CONCLUSIONS: PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. Substantial heterogeneity in PRO instrument selection suggests a lack of standardization and limits the interpretability and downstream value of PRO evidence. Greater alignment in PRO selection may enhance relevance to regulatory, payer, and clinical decision-making.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT32
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology