Molecular Dx Landmark-class

NCI-MATCH Trial: Lessons from the Largest Tumour-Agnostic Precision Oncology Study

The NCI-MATCH trial screened nearly 6,000 patients with treatment-refractory solid tumours using next-generation sequencing and assigned 1,593 to one of 38 genomically matched substudies. Seven of the initial 27 substudies (26%) met their signal-seeking objective for tumour response, validating the feasibility of large-scale, tumour-agnostic precision medicine trials. The authors discuss key design and operational lessons for future biomarker-driven platform trials.

The original study

The NCI-MATCH trial: lessons for precision oncology.

Authors
O'Dwyer PJ, Gray RJ, Flaherty KT, Chen AP, Li S, Wang V, et al.
Journal
Nature medicine
Type
Journal Article, Review
PMID
37322121
Read the original study →

Original abstract

The NCI-MATCH (Molecular Analysis for Therapy Choice) trial ( NCT02465060 ) was launched in 2015 as a genomically driven, signal-seeking precision medicine platform trial-largely for patients with treatment-refractory, malignant solid tumors. Having completed in 2023, it remains one of the largest tumor-agnostic, precision oncology trials undertaken to date. Nearly 6,000 patients underwent screening and molecular testing, with a total of 1,593 patients (inclusive of continued accrual from standard next-generation sequencing) being assigned to one of 38 substudies. Each substudy was a phase 2 trial of a therapy matched to a genomic alteration, with a primary endpoint of objective tumor response by RECIST criteria. In this Perspective, we summarize the outcomes of the initial 27 substudies in NCI-MATCH, which met its signal-seeking objective with 7/27 positive substudies (25.9%). We discuss key aspects of the design and operational conduct of the trial, highlighting important lessons for future precision medicine studies.