Studieoverzicht

Study name: Dose tapering and early discontinuation to increase cost-effectiveness of immunotherapy trial number 1

Histology	NSCLC
Tumor stage	Stage IV
Host / recruiting sites	Erasmus MC
Enrollment	Closed
Design	An open label randomized non-inferiority study.
Intervention	Patients will be randomized to standard of care versus reduced dose pembrolizumab.
Key outcome parameters	One-year overall survival rate
Key inclusion criteria	Eligible for treatment of non-small cell lung cancer with pembrolizumab in line with the current ESMO treatment guidelines Known PD-L1 status (performed on cytology or histology)
Key exclusion criteria	Subjects with symptomatic untreated CNS metastases are excluded. Prior treatment with an 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 checkpoint pathways. Treatment with adjuvant or neoadjuvant chemotherapy 3 months prior to enrolment.
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