NCT03853187

Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer

Imaging Tumor-infiltrating CD8+ T-cells in Non-small Cell Lung Cancer Upon Neo-adjuvant Treatment With Durvalumab (MEDI4736)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional study, to assess feasibility and safety of durvalumab (MEDI4736) in neo-adjuvant setting in patients with resectable NSCLC. Additional analyses of potential imaging biomarkers, e.g. Zr-89 labelled durvalumab (MEDI4736), ex vivo In-111-oxine labelled CD8+ T-cells and high-resolution immune cell imaging, in relation to immunotherapy induced immune responses on quantitative immune histochemical analysis of the resected tumor specimen, will be performed.

Detailed description

This is an interventional study in 20 patients with resectable non-small cell lung cancer who will receive 2 courses of durvalumab (MEDI4736) in the neo-adjuvant setting, followed by surgery with curative intent. Experimental imaging procedures include 1) Zr-89-labelled durvalumab (MEDI4736) scan prior to neo-adjuvant treatment to determine accessibility and intra-tumoral distribution of durvalumab (MEDI4736) and 2) (first cohort) injection of ex vivo \[111In\]-oxine labelled autologous CD8+ T-cells 48 hours prior to surgery, or (second cohort) injection of \[89Zr\]-Df-crefmirlimab prior to surgery. The scan is scheduled on the day of surgery and after surgery, the resected tumor specimen with ex vivo \[111In\]-oxine labelled or in vivo \[89Zr\]-Df-crefmirlimab labelled CD8+ T-cells in situ, is fixated for high-resolution ex vivo imaging on a preclinical U-SPECT scanner and quantitative histopathological analysis, next to standard histopathological evaluation. Total duration of the study is maximum 42 days (from injection therapeutic dose durvalumab (MEDI4736) to surgery).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Zr-89 labelled durvalumab PET/CT	Patients will undergo a Zr-89 labelled durvalumab (MEDI4736) PET/CT and dedicated perfusion-CT prior to treatment with durvalumab (MEDI4736) and in- and ex-vivo In-111-oxine or in-vivo \[89zr\]-Df-crefmirlimab labelled CD8+ T-cells after two courses of treatment, prior to surgery.
DRUG	Durvalumab (MEDI4736)	Patients will receive two courses of durvalumab (MEDI4736)at a fixed dose of 750mg Q2W intravenously, prior to scheduled resection of NSCLC.

Timeline

• Start date: 2019-09-19
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2019-02-25
• Last updated: 2022-12-07

Locations

1 site across 1 country: Netherlands