None listed
Conditions
Brief summary
The ImmunoPET study aims to assess whether it is feasible to use 89Zr-durvalumab (89Zr-durva) as a PET tracer of PD-L1 (a cancer related protein) in patients with cancer. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive an injection in the arm containing the 89Zr-durva tracer 30 minutes prior to completing a PET scan on Day 0. A further 3 PET scans will be taken 24 hours, 3 days and 5 days after the injection of the 89Zr-durva tracer. Each PET scan will take approximately 30-45 minutes. Blood tests will be taken at each of these PET scans. About 15-20ml of blood will be taken at each PET scan. It is hoped that this study will help determine if 89Zr-durvalumab (89Zr-durva) is a feasible option for use as a tracer of PD-L1.
Interventions
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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed