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Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor

Not Yet RecruitingPhase 2, Phase 3

Sponsor: Radboud University Medical Center

Conditions: NSCLC

Interventions: Sasanlimab, non-ablative radiotherapy, [89Zr]Zr-crefmirlimab berdoxam

Countries: Germany, Netherlands

This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with \[89Zr\]crefmirlimab berdoxam PET imaging as an imaging biomarker.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age \>50 years
* Histologically or cytologically proven adenocarcinoma or squamous cell lung cancer
* Primary tumors \>1 cm and \</= 5 cm largest diameter
* Scheduled for curative surgery
* Informed consent
* Adequate bone marrow function (ANC \>/= 1500, platelets \>/=100k, Hgb \> 9), renal function (CLCr \>30 mL/min), liver function (TotalBili \</= 1.5 x ULN; AST and ALT \</=2.5 x ULN).

Exclusion Criteria:

* Inability to undergo SPECT or PET scans
* Pleiomorphic, lepidic, mucinous or large cell neuro-endocrine histological subtypes of non-small cell lung carcinoma
* Histologically confirmed druggable mutation (EGFR, RET, ROS, ALK, BRAF V600, NTRK, NRG1, MET ex14Sk)
* Pregnancy or lactation
* Active infection, auto-immune disease, prior organ-transplantation or haematological condition that requires medication that potentially interferes with immune cell activation.
* Documented medical history of auto-immune disease, organ-transplantation or haematological condition that potentially interferes with immune cell behavior
* Prior radiation therapy to the chest
* Splenectomy
* Enrolled in a current investigational drug trial

Locations (2)

Tübingen, Germany
Nijmegen, Gelderland, Netherlands