NCT03514719

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The programmed death 1 (PD1)/ programmed death ligand 1 (PD-L1) pathway plays an important role in regulating the T-cell anti tumor response. Blocking this interaction with the anti PD-L1 monoclonal antibody avelumab is effective in patients with non-small cell lung cancer (NSCLC) resulting in durable disease control rates. Currently, PD-L1 expression as determined by immune histochemistry (IHC) is the best available biomarker for treatment response, but standardized scoring criteria are lacking and the risk for sampling errors exists. Molecular imaging using 89Zr-labeled antibodies may overcome these limitations, enabling the visualization of PD-L1 expression in primary and metastatic tumor lesions and providing information on the in vivo accessibility of the PD-L1 target following intravenous administration. This study enables PD-L1 PET-imaging with 89Zr-avelumab in patients with: * early stage NSCLC (stage Ia (≥T1b) -IIIa) followed by 2 cycles of neo-adjuvant avelumab treatment and surgical resection of the tumor. * advanced stage NSCLC (Stage IIIb-IV) followed by avelumab treatment until disease progression or intolerable toxicity.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-09-15
• Completion: 2021-12-02
• First posted: 2018-05-02
• Last updated: 2022-01-10

Locations

1 site across 1 country: Netherlands