Status:
NOT_YET_RECRUITING
Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Pfizer
ImaginAb, Inc.
Conditions:
NSCLC
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 berd...
Detailed Description
This is a two-armed open-label feasibility study with exploratory endpoints, where subjects are participating for 2 years after completement of enrollment to determine disease-free survival rates. The...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06218069
Start Date
February 1 2025
End Date
March 1 2027
Last Update
November 29 2024
Active Locations (2)
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1
Eberhard Karls Universitaet Tuebingen (EKUT)
Tübingen, Germany, 72074
2
Radboud University Medical Center (Radboudumc)
Nijmegen, Gelderland, Netherlands, 6525 GA