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. 2025 Jul 15:11:20552076251348584.
doi: 10.1177/20552076251348584. eCollection 2025 Jan-Dec.

Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study

Melissa L Santorelli  1 , Oliver Schmalz  2 , Mathias Hoiczyk  3 , David Heigener  4 , Clemens Schulte  5 , Markus Knott  6 , Petra Hoffknecht  7 , Joonas Vainio  8 , Thomas Burke  1 , Josephine M Norquist  1 , Sabine Riehl  9 , Alexander Hildner  9 , Lisa Barthuber  10 , Sabine Bohnet  11
Affiliations

Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study

Melissa L Santorelli et al. Digit Health. .

Abstract

Introduction: Close symptom monitoring can benefit patients with metastatic nonsmall cell lung cancer (mNSCLC) receiving first-line therapy. Remote patient monitoring technologies, like the artificial intelligence (AI)-enabled Kaiku® Health platform that allows oncology patients to report their health status in real-time to healthcare providers, may enhance patients' treatment experience.

Methodology: The lung artificial intelligence-enabled digital solution pilot study ("Lung AID") assessed the feasibility of future studies on Kaiku® Health in patients with mNSCLC receiving first-line pembrolizumab in Germany. Patient engagement with Kaiku® Health and practicality of collecting patient-reported outcomes (PROs) via the separate Lung AID EDC system were assessed by platform access rates. Kaiku® Health access required one login, while Lung AID EDC access required submission of ≥1 PRO questionnaire. Post hoc analyses explored access by site experience with Kaiku® Health.

Results: Over a 17-month enrollment period, 47 of 100 planned patients were enrolled in the study. Kaiku® Health was accessed by 85.1% of patients, with higher engagement at experienced sites (96.2%). Only 38.3% accessed the Lung AID EDC system; 31.9% used both systems.

Discussion: High Kaiku® Health access rates imply patient interest in remote digital monitoring for mNSCLC. However, recruitment challenges and use of a separate system to collect PRO data demonstrated difficulties in assessing the feasibility of these technologies in real-world settings. Our results highlight the need for streamlined patient monitoring tools and enhanced site and patient engagement strategies.

Conclusion: While definitive conclusions on future studies cannot be drawn, the study offers key insights into challenges that should be considered in future research.

Keywords: AI; NSCLC; PRO; pembrolizumab; real-world; remote symptom monitoring.

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