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...

Overview

Journal Lancet Oncol

Specialty Oncology

Date 2024 Oct 3

PMID 39362260

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

Affiliations

Soon will be listed here.

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.

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