Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000840482
Ethics application status
Approved
Date submitted
7/07/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDl4736) - Phase 1
Scientific title
IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDl4736) - Phase 1
Secondary ID [1] 313642 0
None
Universal Trial Number (UTN)
Trial acronym
ImmunoPET
Linked study record
This record refers to the phase 1/expanded phase of the ImmunoPET study. Phase 0 is recorded on ACTRN12621000171819

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 336206 0
Condition category
Condition code
Cancer 332741 332741 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 in phase 1 of the ImmunoPET study (i.e participants 11 through 30) as a slow IV infusion at day 0, two weeks and within 42 days after last radiotherapy treatment (Phase I of the study). Participants will be scanned once per timepoint and between 72-144 hours after the infusion. Each PET scan will take approximately 30 minutes.
Intervention code [1] 330234 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] 340272 0
To investigate the interaction of 89Zr -durva with malignant tissues.
Timepoint [1] 340272 0
Participants will be scanned once per timepoint and between 72-144 hours after the infusion of 89Zr-durva at day 0, two weeks and within 42 days after last radiotherapy treatment
Primary outcome [2] 340273 0
To record any toxicity potentially associated with the 89Zr-durva PET tracer
Timepoint [2] 340273 0
From baseline until 30 days after the last dose of 89Zr-durva.
Secondary outcome [1] 443560 0
To record any toxicity potentially associated with the 89Zr-durva PET tracer
Timepoint [1] 443560 0
From baseline until 30 days after the last 89Zr-durva PET scan

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 meeting clinical criteria for concurrent chemo-radiotherapy with curative intent
7. Histopathology with PD-L1 positive tumour cells >25%. Any PDL-1 status, any EGFR mutation status/ALK4 mutation status
8. Subjects with an estimated glomerular filtration rate (eGFR) > 5oml/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. Known sensitivity or allergy to anti-PD-L1 agents
2. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
3, Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
4. Any previous therapy that precludes treatment with concurrent chemo-radiation (radiotherapy, chemotherapy, and immunotherapy).
5. Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses. which are not to exceed 10 mg/day of prednisone. or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
6. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
7. Any prior Grade 3 or greater immune-related adverse event (irAE) while receiving any previous immunotherapy agent. or any unresolved irAE >Grade 1
8. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access or EBUS or mediastinal biopsy) that would prevent administration of study drug
9. Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo. Grave's disease. or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
10. Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
11. History of primary immunodeficiency
12. History of organ transplant that requires therapeutic immunosuppression
13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection. symptomatic congestive heart failure. uncontrolled hypertension. unstable angina pectoris. cardiac arrhythmia. active peptic ulcer disease or gastritis. active bleeding diatheses including any patient known to have hepatitis B. hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
14. Active infection including tuberculosis. hepatitis B. or hepatitis C.
15. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study drug.
16. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
17. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
18. PET contraindications. e.g. Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with hepatic excretion)
19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results

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
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
30
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318109 0
Commercial sector/Industry
Name [1] 318109 0
AstraZeneca Pty Ltd
Country [1] 318109 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 320484 0
None
Name [1] 320484 0
Address [1] 320484 0
Country [1] 320484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316754 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 316754 0
Ethics committee country [1] 316754 0
Australia
Date submitted for ethics approval [1] 316754 0
05/06/2020
Approval date [1] 316754 0
02/12/2020
Ethics approval number [1] 316754 0

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

Contacts
Principal investigator
Name 138906 0
Dr Fiona Hegi-Johnson
Address 138906 0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Country 138906 0
Australia
Phone 138906 0
+61 385597720
Fax 138906 0
Email 138906 0
[email protected]
Contact person for public queries
Name 138907 0
Fiona Hegi-Johnson
Address 138907 0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Country 138907 0
Australia
Phone 138907 0
+61 385597720
Fax 138907 0
Email 138907 0
[email protected]
Contact person for scientific queries
Name 138908 0
Fiona Hegi-Johnson
Address 138908 0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Country 138908 0
Australia
Phone 138908 0
+61 385597720
Fax 138908 0
Email 138908 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sponsor decision



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
No additional documents have been identified.