Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer: Protocol for a Bayesian Optimal Phase I/II Trial.

Prior attempts to escalate radiation dose for non-small cell lung cancer (NSCLC) have not improved survival. Given the high risk for cardiopulmonary toxicity with treatment and heterogenous presentation of locally advanced NSCLC, it is unlikely that a single dose regimen is optimal for all patients. This phase I/II trial aims to evaluate a novel treatment approach where the level of accelerated hypofractionation is determined by the predicted toxicity from dose to organs at risk (OARs). Patients ≥ 18 years old with lung cancer planned for fractionated radiotherapy to the lung with concurrent chemotherapy will be eligible. Radiation therapy (RT) will be delivered to a total dose of 60 to 66 Gy in 30, 25, or 20 fractions depending on the ability to meet constraints to key organs at risk including the lungs, heart, and esophagus. The primary endpoint is high grade pulmonary, esophageal, or cardiac toxicity. A Bayesian optimized design is used to determine stopping boundaries and evaluate the primary endpoint. PACER will evaluate the safety and feasibility of personalized accelerated chemoradiotherapy for lung cancer.

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Disclosure Billy W Loo: co-founder and board member of TibaRay and a consultant on a clinical trial steering committee of Beigene, and has received lecture honorarium from Mevion; Joel W Neal: ASCO; Millie Das: consulting with Genentech and Eurofins; participation on the advisory board for AstraZeneca, Beigene, Sanofi/Genzyme, and Janssen; and research with Merck, Genentech, CellSight, Novartis, AbbVie, United Therapeutics, Verily, Varian Medical Systems and Celgene. Heather Wakelee: grants with ACEA Biosciences, Arrys Therapeutics, AstraZeneca/Medimmune, Bristol-Myers Squibb, Clovis Oncology, Genentech/Roche, Merck, Novartis, SeaGen, Xcovery, and Helsinn; participation on the advisory board for AstraZeneca, Blueprint, Mirati, Merck, and Genentech/Roche; and leadership with International Association for the Study of Lung Cancer and ECOG-ACRIN; Maximilian Diehn: grants with Varian, Genentech, and AstraZeneca; royalties for patent license with Roche and Foresight Diagnostics; consulting fees with Roche Sequencing Solutions, Varian, BioNTech, RefleXion, Novartis, Illumina, Genentech, BioNTech, Boehringer Ingelheim, and Gritstone Oncology; patents with Roche, Foresight Diagnostics, and Celgene; participation on the advisory board for AstraZeneca, Genentech, Boehringer Ingel- heim, Illumina, and Gritstrone; leadership as a board member of Foresight Diagnostics; stock holdings with Foresight Diagnostics and CiberMed; and in-kin research from Illumina; Lucas Vitzthum: grants from RefleXion Medical; Mohona Roy: Speakers' Bureau: MJH Life Sciences; Research Funding: Varian Medical Systems (Inst); Nathaniel Myall: Honoraria: Patient Power; Kavitha Ramchandran: Consulting or Advisory Role: Drishti, GroupWell, Varian Medical Systems. The remaining authors declare no conflict of interest.