NCT03065764

89Zr-labeled Pembrolizumab in Patients With Non-small-cell Lung Cancer

89Zirconium-labeled Pembrolizumab as Predictive Imaging Biomarker of Response and Toxicity in Pembrolizumab Treated Patients With Non-small-cell Lung Cancer - a Feasibility Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After a screening phase of up to 42 days, eligible subjects will undergo two whole body immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with and one without a preceding "cold" therapeutic dose of pembrolizumab. For the first 3 patients, PET scans will be obtained at 1, 72 and 120 hours post tracer injection to determine the optimal scan time point and to perform biodistribution measurements and dosimetry. All subsequent patients receive only 1 PET scan post-injection (i.e. two PET scans). The optimal time point is expected to be at day 5 post-injection. Pembrolizumab treatment will continue every three weeks until two years of therapy have been administered, disease progression, or unacceptable adverse event(s).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	89Zr-Pembrolizumab	eligible subjects will undergo two whole body immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with and one without a preceding "cold" therapeutic dose of pembrolizumab.

Timeline

• Start date: 2017-01-20
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-02-28
• Last updated: 2017-08-17

Locations

1 site across 1 country: Netherlands