ImmunoPET: IMaging of cancer imMUNOtherapy targets with positron Emission Tomography: a phase 0/1 study characterising PD-L1 with 89 Zr-durvalumab (MEDI4736) PET/CT in stage III NSCLC patients receiving chemoradiation study protocol.

Background: ImmunoPET is a multicentre, single arm, phase 0-1 study that aims to establish if ⁸⁹ Zr-durvalumab PET/CT can be used to interrogate the expression of PD-L1 in larger, multicentre clinical trials.
Methods: The phase 0 study recruited 5 PD-L1+ patients with metastatic non-small cell lung cancer (NSCLC). Patients received 60MBq/70 kg ⁸⁹ Zr-durva up to a maximum of 74 MBq, with scan acquisition at days 0, 1, 3 or 5±1 day. Data on (1) Percentage of injected ⁸⁹ Zr-durva dose found in organs of interest (2) Absorbed organ doses (µSv/MBq of administered ⁸⁹ Zr-durva) and (3) whole-body dose expressed as mSv/100MBq of administered dose was collected to characterise biodistribution.The phase 1 study will recruit 20 patients undergoing concurrent chemoradiotherapy for stage III NSCLC. Patients will have ⁸⁹ Zr-durva and FDG-PET/CT before, during and after chemoradiation. In order to establish the feasibility of ⁸⁹ Zr-durva PET/CT for larger multicentre trials, we will collect both imaging and toxicity data. Feasibility will be deemed to have been met if more than 80% of patients are able complete all trial requirements with no significant toxicity.
Ethics and Dissemination: This phase 0 study has ethics approval (HREC/65450/PMCC 20/100) and is registered on the Australian Clinical Trials Network (ACTRN12621000171819). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and must be submitted to the approving HREC for review and approval.
Trial Registration Number: Australian Clinical Trials Network ACTRN12621000171819.
Competing Interests: Competing interests: FH-J has clinical trial funding, has received honoraria and participated in advisory boards for Astra Zeneca. She has received payments and honoria from BeiGene and MSD for lectures and presentations. Her work is supported by the Peter Mac Foundation and the Victorian Cancer Agency. SER and PSD are inventors on intellectual property relating to the use of DFOSq that have been licensed from the University of Melbourne to Telix Pharmaceuticals. TJ has received payments and honoraria from BMS and Astra Zeneca for lectures and presentations, and sits on Data Safety and Monitoring Boards or Advisory boards for Roche, BMS, Astra Zeneca, Novartis, Amgen, Puma, MSD and Merck. SF has received payments and honoraria from Astra Zeneca, Roche, Amgen, Novartis, Bayer, GSK, BMS, MSD and Janssen for lectures and presentations. KB has received payments and honoraria from Bayer and Abbvie for lectures and presentations and participates on Data Safety and Monitoring boards for Novartis.
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