IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDI4736)

Phase 1

Recruiting

• Conditions: on Small Cell Lung Cancer; Non Small Cell Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12621000171819
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-18
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified