Challenges and Opportunities for Early Phase Clinical Trials of Novel Drug-Radiotherapy Combinations: Recommendations From Nrg Oncology, the American Society for Radiation Oncology (Astro), The American College of Radiology (Acr), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (Acro)

Authors

Zachary S Zumsteg
Siddharth Sheth
Salma K Jabbour
Krishnan R Patel
Randall J Kimple
Terence M Williams
Meng Xu-Welliver
Pedro A Torres-Saavedra
Arta M Monjazeb
Jyoti Mayadev
Steven E Finkelstein
John M Buatti
Sandip P Patel
Steven H Lin

Publication Date

10-1-2024

Journal

Lancet Oncology

Abstract

NRG Oncology's Developmental Therapeutics and Radiation Therapy Subcommittee assembled an interdisciplinary group of investigators to address barriers to successful early phase clinical trials of novel combination therapies involving radiation. This Policy Review elucidates some of the many challenges associated with study design for early phase trials combining radiotherapy with novel systemic agents, which are distinct from drug-drug combination development and are often overlooked. We also advocate for potential solutions that could mitigate or eliminate some of these barriers, providing examples of specific clinical trial designs that could help facilitate efficient and effective evaluation of novel drug-radiotherapy combinations.

Keywords

Animals, Antineoplastic Agents, Biomarkers, Tumor, Chemoradiotherapy, Clinical Trials as Topic, Drug Discovery, Drug Interactions, Neoplasm Staging, Neoplasms, Societies, Medical, Humans

DOI

10.1016/S1470-2045(24)00264-X

PMID

39362260

PMCID

PMC11778933

PubMedCentral® Posted Date

1-29-2025

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes