Consensus statement on ctDNA minimal residual disease (MRD) testing in early-stage NSCLC: A Delphi study by the Asian Thoracic Oncology Research Group (ATORG).

Abstract

289 Background: Minimal residual disease (MRD) detection using liquid biopsy is an emerging tool for risk stratification and monitoring for recurrence in resected early-stage NSCLC. There is increasing need for clear guidance on its optimal clinical implementation. Methods: The Asian Thoracic Oncology Research Group (ATORG) convened a multi-disciplinary panel of 27 experts to develop a consensus statement on the clinical application of ctDNA-based MRD testing in early-stage resected NSCLC, using a structured Delphi methodology. Statements were organized into broad thematic domains: assay validity and standardization; harmonization in research and trials; clinical application; challenges in implementation; consensus recommendations; infrastructure for regional MRD adoption; and roadmap for pragmatic trials. Results: A total of 23 position statements were developed, of which all except one achieved strong consensus. The consensus highlighted the need to define minimum analytical performance thresholds for MRD assays, improve standardization of reporting metrics, and clear guidelines for pre-analytical handling. Harmonization of blood sampling timepoints and terminology across clinical trials is also essential to confirm the prognostic value of MRD assays. While current MRD assays demonstrate high specificity and positive predictive value, variable sensitivity precludes routine use for adjuvant therapy de-escalation outside clinical trials. Broader access, sustainable funding, ongoing consensus building and collaborative real-world data generation are also critical to support clinical implementation and adoption. Future clinical trials must account for the distinct biology and changing standards of care associated with different driver genes. Conclusions: These consensus recommendations provide a pragmatic framework to guide the responsible integration of MRD testing into clinical research and practice.