Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (IMPRINT)

Radboud University Medical Center

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: NSCLC

Treatments: Radiation: non-ablative radiotherapy; Drug: Sasanlimab; Drug: [89Zr]Zr-crefmirlimab berdoxam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06218069

IMAGIO-IMPRINT

Details and patient eligibility

About

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.

Full 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 therapeutic intervention is a single subcutaneous administration of the humanized hinge region-stabilized IgG4 monoclonal anti-PD1 antibody PF-06801591 (sasanlimab) in a fixed dose of 300 mg in a neo-adjuvant setting, with or without radiation therapy, followed by curative-intended surgery. The diagnostic intervention is a radiolabeled imaging tracer [89Zr]Zr-crefmirlimab berdoxam that entails two intravenous administrations of a fixed dose of 1.5 mg protein dose labelled with activity dose 37 MBq Zirconium-89; one at baseline and one at 2 weeks after sasanlimab injection, to visualize CD8+ T-cells in vivo.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Site EKUT (Tuebingen)

Active Comparator group

Description:

Patients will receive a single subcutaneous administration of the immunotherapy sasanlimab in a fixed dose of 300 mg in a neo-adjuvant setting, followed by curative-intended surgery. Patients will also receive a radiolabeled imaging tracer \[89Zr\]Zr-crefmirlimab berdoxam that entails two intravenous administrations of a fixed dose of 1.5 mg protein dose labelled with activity dose 37 MBq Zirconium-89; one at baseline and one at 2 weeks after sasanlimab injection.

Treatment:

Drug: [89Zr]Zr-crefmirlimab berdoxam

Drug: Sasanlimab

Site Radboudumc (Nijmegen)

Active Comparator group

Description:

Patients will receive a single subcutaneous administration of the immunotherapy sasanlimab in a fixed dose of 300 mg in a neo-adjuvant setting, and 3 days of non-ablative dose radiation therapy starting with sasanlimab injection. This is followed by curative-intended surgery. Patients will also receive a radiolabeled imaging tracer \[89Zr\]Zr-crefmirlimab berdoxam that entails two intravenous administrations of a fixed dose of 1.5 mg protein dose labelled with activity dose 37 MBq Zirconium-89; one at baseline and one at 2 weeks after sasanlimab injection.

Treatment:

Drug: [89Zr]Zr-crefmirlimab berdoxam

Drug: Sasanlimab

Radiation: non-ablative radiotherapy