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 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.
Contact information