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

Sponsor
Radboud University Medical Center
Study ID
NCT03853187
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zr-89 labelled durvalumab PET/CT — RADIATION
    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.
  • Durvalumab (MEDI4736) — DRUG
    Patients will receive two courses of durvalumab (MEDI4736)at a fixed dose of 750mg Q2W intravenously, prior to scheduled resection of NSCLC.

Study Details

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.

Key Dates

Start date
Sep 19, 2019
Status verified
Oct 2021
Primary completion
Dec 6, 2022
Completion
Dec 6, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab (MEDI4736) neo-adjuvant
    Patients will receive two courses of durvalumab (MEDI4736)at a fixed dose of 750mg Q2W intravenously, prior to scheduled resection of NSCLC. Patients are amendable to adjuvant chemo and/or radiation treatment, per standard-of-care. Additionally, patients will undergo a Zr-89 labelled durvalumab (MEDI4736) PET/CT and dedicated perfusion-CT prior to treatment with durvalumab (MEDI4736) and ex vivo In-111-oxine or in vivo \[89Zr\]-Df-crefmirlimab labelled CD8+ T-cells after two courses of treatment, prior to surgery.

Primary Outcome Measure

Safety of neo-adjuvant durvalumab: number of NCI CTCAE v 5.0 grade ≥3 [ Time Frame: 14 days ]

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