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) - 01/10/24

Doi : 10.1016/S1470-2045(24)00264-X

Zachary S Zumsteg, MD ^a,⁎ , Siddharth Sheth, DO ^b, Salma K Jabbour, ProfMD ^c, Krishnan R Patel, MD ^d, Randall J Kimple, MD PhD ^f, Terence M Williams, ProfMD PhD ^g, Meng Xu-Welliver, MD PhD ^h, Pedro A Torres-Saavedra, PhD ^e, Arta M Monjazeb, ProfMD PhD ⁱ, Jyoti Mayadev, ProfMD ^j, Steven E Finkelstein, MD ^l,^m,ⁿ, John M Buatti, ProfMD ^o, Sandip P Patel, MD ^k, Steven H Lin, ProfMD PhD ^p

^a Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA

^b Division of Oncology, University of North Carolina, Chapel Hill, NC, USA

^c Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA

^d Radiation Oncology Branch, National Cancer Institute, Bethesda, MD, USA

^e Division of Cancer Treatment and Diagnosis, Biometric Research Program, National Institutes of Health, Bethesda, MD, USA

^f Department of Human Oncology, Univeristy of Wisconsin, Madison, WI, USA

^g Department of Radiation Oncology, City of Hope, Duarte, CA, USA

^h Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA

ⁱ Department of Radiation Oncology, University of California, San Diego, CA, USA

^j Department of Radiation Medicine and Applied Sciences, University of California, San Diego, CA, USA

^k Division of Medical Oncology, University of California, San Diego, CA, USA

^l The US Oncology Network, Florida Cancer Affiliates, Panama City, FL, USA

^m Sarah Cannon Research Institute, Nashville, TN, USA

ⁿ Associated Medical Professional of NY, US Urology Partners, Syracuse, NY, USA

^o Department of Radiation Oncology, University of Iowa, Iowa City, IA, USA

^p Department of Thoracic Radiation Oncology, Division of Radiation Oncology, MD Anderson Cancer Center, Houston, TX, USA

^* Correspondence to: Zachary S Zumsteg, Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA Department of Radiation Oncology Cedars-Sinai Medical Center Los Angeles CA 90048 USA

Summary

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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Plan

Introduction

Unique challenges of early phase clinical development of novel drug–radiotherapy regimens

Early phase clinical trial design for drug–radiotherapy combinations

Dose-limiting toxicity definition for early phase drug–radiotherapy trials

Efficacy endpoints for early phase drug–radiotherapy trials

Biomarkers for patient selection or toxicity monitoring

Populations to target for early phase trials of novel drug–radiotherapy combinations

Recommendations for overcoming the challenges of novel drug–radiotherapy early phase trials

Conclusion

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Vol 25 - N° 10

P. e489-e500 - octobre 2024 Retour au numéro

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