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

Fiona Hegi-Johnson*, Stacey E. Rudd, Christian Wichmann, Tim Akhurst, Peter Roselt, Jenny Trinh, Thomas John, Lisa Devereux, Paul S. Donnelly, Rod Hicks, Andrew M. Scott, Daniel Steinfort, Stephen Fox, Benjamin Blyth, Sagun Parakh, Gerard G. Hanna, Jason Callahan, Kate Burbury, Michael MacManus

*Corresponding author for this work

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Abstract

Background: ImmunoPET is a multicentre, single arm, phase 0–1 study that aims to establish if 89Zr-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 89Zr-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 89Zr-durva dose found in organs of interest (2) Absorbed organ doses (µSv/MBq of administered 89Zr-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 89Zr-durva and FDG-PET/CT before, during and after chemoradiation. In order to establish the feasibility of 89Zr-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.
Original languageEnglish
Article numbere056708
JournalBMJ Open
Volume12
Issue number11
DOIs
Publication statusPublished - 18 Nov 2022
Externally publishedYes

Bibliographical note

Funding Information:
This is an investigator-initiated study sponsored by Peter MacCallum Cancer Centre. This work was supported by Astra Zeneca grant number ESR-18-14346. The durvalumab and DFO-squaramide chelator were provided pro bono by Telix and Astra Zeneca.

Funding Information:
This is an investigator-initiated study sponsored by Peter MacCallum Cancer Centre. This work was supported by Astra Zeneca grant number ESR-18-14346

Funding Information:
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.

Publisher Copyright:
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Keywords

  • Nuclear radiology
  • Radiation oncology
  • Respiratory tract tumours

ASJC Scopus subject areas

  • Medicine(all)

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