PD-L1 PET (AvL)

Key Outcome parameters

Primary endpoints:

• The objective response rate as defined by RECIST
• The outcome measures of ¹⁸F-PD-L1 PET/CT related to the objective response rate as defined by RECIST

Secondary Objectives:

• PFS: the outcome measures of ¹⁸F-PD-L1 PET/CT related to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause
• OS: the outcome measures of ¹⁸F-PD-L1 PET/CT related to the date of death due to any cause
• Tumor and stromal PD-L1 IHC: correlation between PD-L1 expression measured by ¹⁸F-PD-L1 PET/CT and PD-L1 expression measured by IHC

Intervention

All subjects will undergo a whole body 18F-PD-L1 PET/CT scan before nivolumab treatment. Patients will continue treatment with nivolumab according to label until disease progression, withdrawal of patient consent or unacceptable toxicity.

Key inclusion criteria

• Histologically confirmed NSCLC, EGFR WT and ALK fusion negative
• Must be eligible for nivolumab treatment according to EMA label and national guidelines
• ECOG performance status 0-1
• Must have measurable disease based on RECIST v1.1
• Must provide tissue from a histological biopsy of a tumor lesion that is not radiated prior to biopsy and obtained after the last line of systemic therapy, to determine the actual PD-L1 status
• Adequate organ functions

Key exclusion criteria

• Active use of systemic steroids (> 10 mg daily prednisone equivalent)
• Known active additional malignancy, except BCC/SCC of the skin or in situ cervical cancer after curative therapy
• Symptomatic CNS metastases and/or carcinomatous meningitis
• Active auto-immune disease requiring steroids, interstitial lung disease, active infection requiring systemic therapy, known HIV, active hepatitis B or C
• Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways