TheranosticTrials.org

Clinical Trial · NCT03065764

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

Overview

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).

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

EF Smit (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03065764

Drug / Compound

Pembrolizumab

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Be willing and able to provide written informed consent/assent for the trial.
  • Have measurable disease based on RECIST 1.1.
  • 1. Have a histologically or cytologically confirmed diagnosis of stage IV, EGFR wt and EML4/ALK fusion negative NCSLC and have received at least one line of platinum based doublet chemotherapy and disease progression by RECIST 1.1 on the last systemic treatment.
  • Be 18 years of age, or above on day of signing informed consent.
  • Must provide newly obtained tissue from a core or excisional biopsy of a tumor lesion and are willing to undergo a second biopsy when the 89Zr-pembrolizumab PET scan shows heterogeneous uptake.

Exclusion

  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in a dose higher than the equivalent of 10 mg prednisolone once daily or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • 1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  • Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.