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

Non Small Cell Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

• NCT number: NCT03514719
• Study type: Interventional
• Source: Radboud University
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Completion date: December 2, 2021