None listed
Conditions
Brief summary
The lmmunoPET 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 about 3 days prior to completing a PET scan. Each PET scan will take approximately 30 minutes. This infusion will take place at three timepoints: before radiotherapy, 14 days after starting radiotherapy and approximately 42 days after radiotherapy treatment has finished. Blood tests will be taken at each of these PET scans. About 15 to 2oml 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 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 a
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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
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 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.
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
Outcome results
None listed