/ Amsterdam UMC / NSCLC /
PD-L1 PET (AvL)
18 F-PD-L1 PET/CT to predict response to nivolumab in patients with NSCLC
Enrollment
Recruiting
No. of patients
0
Population
Eighty patients with NSCLC that are eligible for nivolumab treatment according to EMA label and national guidelines will be enrolled in this trial.
Design
Single arm, imaging study
![](https://longoncologie.nl/app/uploads/2023/01/fig-pd-l1-pet.jpg)
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
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