Trial Identifiers
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Scientific Title
A Bioimaging Study of 89Zr-M7824 PET Scans in Patients With Advanced or Metastatic NSCLC Receiving M7824 Alone or in Combination With Chemotherapy
Other Non-Commercial Sponsor
Olivia Newton-John Cancer Research Institute
Summary
Eligible patients will be enrolled into one of two sequential cohorts. In Cohort A, patients will receive an initial intravenous dose (100mg) of zirconium-89 labelled M7824 on Day 1. Sequential imaging will be performed over one week, to determine the biodistribution of 89Zr-M7824 into the tumour and normal tissues. All patients enrolled in Cohort 1, who remain on trial after Day 14, will receive a 1200mg dose of M7824 every two weeks, begining on Cycle 1 Day 15. Patients will receive another dose on Day 29 and on Day 43, every two weeks until disease progression or unacceptable toxicity. Patients who do not achieve complete remission in the Cohort after 3 doses of M7824 in Cycle 1 may commence treatment with concurrent carboplatin and pemetrexed chemotherapy at a conventional dose. Similar assessments will be undertaken in Cohort B; Cohort A will be used to determine whether or not high-PD-L1 positive disease is required upon entry to Cohort B.