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PD-L1 Imaging in Non Small Cell Lung Cancer' (PINNACLE)

NCT03514719 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-01-10

No results posted yet for this study

Summary

In this feasibility study, a zirconium-89 (89Zr)-avelumab positron emission tomography (PET) scan will be performed in 37 patients prior to treatment with avelumab to:

1. assess the tumor and systemic tissue uptake 89Zr-avelumab
2. assess the potential to predict avelumab treatment response

Conditions

  • Non Small Cell Lung Cancer

Interventions

DIAGNOSTIC_TEST

89Zr-avelumab PET

89Zr-avelumab injection followed by 89Zr-Avelumab PET scan

DRUG

Avelumab

Early stage disease (stage Ia (≥T1b tumor)-IIIa: neo-adjuvant avelumab treatment (10mg/kg iv q2w) for a maximum duration of 2 cycles after PET-imaging, followed by surgical resection of the tumor with curative intent Stage IIIb-IV disease: systemic treatment with avelumab 10mg/kg iv q2w after PET-imaging

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • C.M.L. van Herpen, Prof.dr. · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-09-15
Completion
2021-12-02

Countries

  • Netherlands

Study Locations

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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 NCT03514719 on ClinicalTrials.gov