Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000171819
Ethics application status
Approved
Date submitted
9/11/2020
Date registered
18/02/2021
Date last updated
28/03/2022
Date data sharing statement initially provided
18/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDI4736)
Scientific title
IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDI4736)
Secondary ID [1] 301447 0
None
Universal Trial Number (UTN)
U1111-1253-3611
Trial acronym
ImmunoPET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 317761 0
Condition category
Condition code
Cancer 315828 315828 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consented participants with non-small cell lung carcinoma will be injected with the 89Zr-durvalumab (89Zr-durva) PET tracer prior to scanning. 100MBq of 89Zr-durva will be given to participants as a slow IV infusion at day 0. Participants will be asked to rest for 30 minutes prior to scanning. Additional PET scans will be performed on Day 1, 3 and 5 (4x 89Zr-durva scans in total). Each PET scan will take approximately 30 minutes.
Intervention code [1] 317794 0
Diagnosis / Prognosis
Comparator / control treatment
Scans will be compared to standard-of-care 18F-FDG PET scans. These scans are usually performed once to assess the staging of the non-small cell carcinoma (before treatment starts).
Control group
Active

Outcomes
Primary outcome [1] 324081 0
To investigate the biodistribution of 89Zr-durva by percentage of injected 89Zr-durva dose found in organs of interest.
This will be assessed using the 89Zr-durva PET scans.
Timepoint [1] 324081 0
Days 0, 1 and 3 and 5 days post-injection (± 1 day) of 89Zr-durva.
Primary outcome [2] 326058 0
To investigate the dosimetry of 89Zr-durva by absorbed organ doses expressed as micro Sv/MBq of administered 89Zr-durva, and whole-body dose expressed as milliSv/100MBq of administered dose.
This will be assessed using the 89Zr-durva PET scans.
Timepoint [2] 326058 0
Days 0, 1 and 3 and 5 days post-injection (± 1 day) of 89Zr-durva.
Primary outcome [3] 326059 0
Define the optimal imaging time-point for qualitative assessment of 89Zr-durva. The optimal imaging time-point will be defined by identifying the timepoint at which the percentage of injected 89Zr-durva dose in tumour reaches maximal accumulation and the tracer has washed out of normal tissues.
This will be assessed using the 89Zr-durva PET scans.
Timepoint [3] 326059 0
Days 0, 1 and 3 and 5 days post-injection (± 1 day) of 89Zr-durva.
Secondary outcome [1] 383696 0
To investigate the interaction of 89Zr -durva with malignant tissues.

This will be assessed using the 89Zr-durva PET scans.
Timepoint [1] 383696 0
Phase 0 - Days 0,1,3 and 5 to coincide with scan acquisition and reading by nuclear medicine physician

Eligibility
Key inclusion criteria
1. Written informed consent provided.
2. Female or male
3. Life expectancy greater than or equal to 12 weeks
4. Minimum age greater than or equal to 18 years, no maximum age.
5. Body weight >30kg
6.Patients with NSCLC and with advanced incurable disease, and with metastatic disease apparent on FDG-PET
7. Histopathology with PD-L1 positive tumour cells >25%. Although, in the metastatic setting >50% is the accepted cut-off, the threshold for Stage III patients remains poorly defined. A cut-off of >25% to broaden the eligibility criteria for enrolment is considered appropriate in this study
8. Subjects with an estimated glomerular filtration rate (eGFR) > 50ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
9. Eastern Cooperative Group Oncology Group (ECOG) performance score of 0-2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or breastfeeding females
2. Known sensitivity or allergy to anti-PD-L1 agents
3. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
4. Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase 0 Biodistribution Study
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis
In the feasibility phase, 5 patients will be recruited in order to characterise tracer biodistribution and determine the optimal imaging time points post-trace administration. This will inform the imaging protocol for the expansion phase of the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
31/08/2021
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
5
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 16858 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 18241 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 18242 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 30507 0
3000 - Melbourne
Recruitment postcode(s) [2] 32305 0
3084 - Heidelberg
Recruitment postcode(s) [3] 32306 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305924 0
Commercial sector/Industry
Name [1] 305924 0
AstraZeneca Pty Ltd
Country [1] 305924 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street
Melbourne
VIC 3000
Country
Australia
Secondary sponsor category [1] 307760 0
None
Name [1] 307760 0
Address [1] 307760 0
Country [1] 307760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306172 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 306172 0
Ethics committee country [1] 306172 0
Australia
Date submitted for ethics approval [1] 306172 0
05/06/2020
Approval date [1] 306172 0
02/12/2020
Ethics approval number [1] 306172 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55382 0
Dr Fiona Hegi-Johnson
Address 55382 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 55382 0
Australia
Phone 55382 0
+61 3 8559 7720
Fax 55382 0
Email 55382 0
Fiona.Hegi-Johnson@petermac.org
Contact person for public queries
Name 55383 0
Fiona Hegi-Johnson
Address 55383 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 55383 0
Australia
Phone 55383 0
+61 3 8559 7720
Fax 55383 0
Email 55383 0
Fiona.Hegi-Johnson@petermac.org
Contact person for scientific queries
Name 55384 0
Fiona Hegi-Johnson
Address 55384 0
Department of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 55384 0
Australia
Phone 55384 0
+61 3 8559 7720
Fax 55384 0
Email 55384 0
Fiona.Hegi-Johnson@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImmunoPET: 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.2022https://dx.doi.org/10.1136/bmjopen-2021-056708
N.B. These documents automatically identified may not have been verified by the study sponsor.