AI-HOPE Lung Cancer: a multicenter real-world registry integrating artificial intelligence for metastatic non-small-cell lung cancer

Background: The AI-HOPE Lung Cancer study is a multicenter initiative designed to integrate artificial intelligence (AI) and real-world data to improve outcome prediction in patients with metastatic non-small-cell lung cancer treated with first-line immunotherapy-based regimens. AI-HOPE aims to leverage machine learning (ML) models to generate individualized predictions of progression-free survival (PFS), overall survival (OS), and treatment-related toxicity in a broad, unselected population. Materials and methods: Clinical and imaging data are harmonized and stored within a privacy-compliant infrastructure (San Raffaele Ai CEnter [S-RACE] platform), promoting FAIR (Findable, Accessible, Interoperable and Reusable) data principles and minimizing manual workload. The primary objective is the development of time-to-event models for PFS and OS. Complementary binary classification models will explore early progression, long-term survival, and clinically relevant toxicities. Results: The study includes retrospective (from 2017) and prospective (until 2027) phases across 21 European centers. So far, 920 patients have been recruited for the study, of whom 621 have baseline imaging scans available for centralized analysis. In the AI-HOPE study, a flexible methodological approach integrates multiple ML models tailored to specific clinical questions, complemented by explainable AI tools. Multimodal models combining clinical variables with computed tomography and [18F]2-fluoro-2-deoxy-D-glucose—positron emission tomography imaging features (when available) are supported through the S-RACE platform, which provides a partially automated imaging analysis workflow. Conclusions: By combining structured clinical variables and multimodal imaging data, the AI-HOPE Lung Cancer study aims to support refined risk stratification and treatment personalization, ultimately facilitating the responsible integration of AI into routine thoracic oncology practice.