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

doi:10.1136/bmjopen-2021-056708

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

Research output: Contribution to journal › Article › peer-review

17 Citations (Scopus)

50 Downloads (Pure)

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 language	English
Article number	e056708
Journal	BMJ Open
Volume	12
Issue number	11
DOIs	https://doi.org/10.1136/bmjopen-2021-056708
Publication status	Published - 18 Nov 2022
Externally published	Yes

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

General Medicine

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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
Copyright 2022 the authors. This is an open access Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction for non-commercial purposes, provided the author and source are cited.
Final published version, 1.23 MBLicence: CC BY-NC

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Hegi-Johnson, F., Rudd, S. E., Wichmann, C., Akhurst, T., Roselt, P., Trinh, J., John, T., Devereux, L., Donnelly, P. S., Hicks, R., Scott, A. M., Steinfort, D., Fox, S., Blyth, B., Parakh, S., Hanna, G. G., Callahan, J., Burbury, K., & MacManus, M. (2022). 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. BMJ Open, 12(11), Article e056708. https://doi.org/10.1136/bmjopen-2021-056708

@article{0c542c37862c4660aa0c25e666c8587a,

title = "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",

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.",

keywords = "Nuclear radiology, Radiation oncology, Respiratory tract tumours",

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

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: {\textcopyright} ",

year = "2022",

month = nov,

day = "18",

doi = "10.1136/bmjopen-2021-056708",

language = "English",

volume = "12",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "11",

}

Hegi-Johnson, F, Rudd, SE, Wichmann, C, Akhurst, T, Roselt, P, Trinh, J, John, T, Devereux, L, Donnelly, PS, Hicks, R, Scott, AM, Steinfort, D, Fox, S, Blyth, B, Parakh, S, Hanna, GG, Callahan, J, Burbury, K & MacManus, M 2022, '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', BMJ Open, vol. 12, no. 11, e056708. https://doi.org/10.1136/bmjopen-2021-056708

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. / Hegi-Johnson, Fiona; Rudd, Stacey E.; Wichmann, Christian et al.
In: BMJ Open, Vol. 12, No. 11, e056708, 18.11.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Hegi-Johnson, Fiona

AU - Rudd, Stacey E.

AU - Wichmann, Christian

AU - Akhurst, Tim

AU - Roselt, Peter

AU - Trinh, Jenny

AU - John, Thomas

AU - Devereux, Lisa

AU - Donnelly, Paul S.

AU - Hicks, Rod

AU - Scott, Andrew M.

AU - Steinfort, Daniel

AU - Fox, Stephen

AU - Blyth, Benjamin

AU - Parakh, Sagun

AU - Hanna, Gerard G.

AU - Callahan, Jason

AU - Burbury, Kate

AU - MacManus, Michael

N1 - 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: ©

PY - 2022/11/18

Y1 - 2022/11/18

N2 - 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.

AB - 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.

KW - Nuclear radiology

KW - Radiation oncology

KW - Respiratory tract tumours

U2 - 10.1136/bmjopen-2021-056708

DO - 10.1136/bmjopen-2021-056708

M3 - Article

C2 - 36400733

AN - SCOPUS:85142401279

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 11

M1 - e056708

ER -

Hegi-Johnson F, Rudd SE, Wichmann C, Akhurst T, Roselt P, Trinh J et al. 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. BMJ Open. 2022 Nov 18;12(11):e056708. doi: 10.1136/bmjopen-2021-056708