A multicenter single arm biomarker exploration and validation study. Eighty patients with NSCLC that are eligible for first line chemo-immunotherapy, first line nivolumab/ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy according to EMA label and national guidelines will be enrolled in this trial. All subjects will undergo a whole body 18F-PD-L1 PET/CT scan before start of nivolumab containing treatment. Patients will continue treatment until disease progression, withdrawal of patient consent or unacceptable toxicity.
18F-PD-L1 PET/CT scan to predict durable reponse to nivolumab containing treatment in patients with NSCLC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
18F-PD-L1 PET/CT scan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
RECRUITINGMeanderMC
Amersfoort, Netherlands
RECRUITINGVUmc
Amsterdam, Netherlands
Progression Free Survival of >= 9 months
The outcome measures of 18F-PD-L1 PET/CT related to the progression-free survival at 9 months according to RECIST 1.1
Time frame: From date of registration until the date of progression-free survival >= 9 months (according to RECIST1.1)
Progression Free Survival
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
Time frame: From date of registration until the date of first documented progression assessed up to 5 months
Overall Survival
The outcome measures of 18F-PD-L1 PET/CT related to the date of death due to any cause
Time frame: From date of registration until the date of death assessed up to 12 months
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
Time frame: Through study completion, an average of 2 years
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Antoni van Leeuwenhoek
Amsterdam, Netherlands
RECRUITINGDeventer Ziekenhuis
Deventer, Netherlands
RECRUITINGLUMC
Leiden, Netherlands
RECRUITINGMedisch Centrum Haaglanden
The Hague, Netherlands
RECRUITINGAntonius Ziekenhuis
Utrecht, Netherlands
RECRUITING