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

NCT03853187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Erik Aarntzen, MD, PhD · Radboud University Medical Center

  • Michel van den Heuvel, MD, PhD · Radboud University Medical Center

  • Jolanda de Vries, MD, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2022-12-06
Completion
2022-12-06

Countries

  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853187 on ClinicalTrials.gov