Studieoverzicht

Study name: Dedication-1 – NVALT 30

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	Radboud UMC	Enrollment	Recruiting
Host / recruiting site 2	MUMC+	Enrollment	Recruiting
Host / recruiting site 3	Erasmus MC	Enrollment	Recruiting
Host / recruiting site 4	UMC Groningen	Enrollment	Recruiting
Therapy line	First line (1L) , Later line (≥2L)
PD-L1 expression	Low: 1 - 49% , High: ≥50%
Design	An open label non-inferiority trial of reduced dose pembrolizumab versus standard of care dose pembrolizumab NSCLC patients who are eligible for treatment with a pembrolizumab-based regimen.
Intervention	Standard of care versus reduced dose pembrolizumab.
Key inclusion criteria	Cytologically or histologically confirmed advanced stage or recurrent NSCLC. Known PD-L1 status eligible for treatment of NSCLC with pembrolizumab
Key exclusion criteria	Symptomatic untreated CNS metastases. Systemic treatment with corticosteroids. Known CD4+ cell count of less than 100 cells/µL Prior treatment with aPD-1/L1/L2 or aCTLA-4 antibody or any antibody targeting t-cell co-stimulation or checkpoint pathways. (neo)adjuvante chemotherapy 3 months prio Non-palliative treatment with chemoradiation for locally advanced disease 3 months prior
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