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
Recruiting
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.
