Dose Tapering and Early Discontinuation to InCreAse cosT-effectIveness Of Immunotherapy for NSCLC
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Rationale: Immune checkpoint inhibitors have shown to improve the overall survival for
patients with metastasized non-small cell lung carcinoma (NSCLC) but the optimal dosing and
patient selection are still a matter of discussion. The pembrolizumab dose, for instance, may
be reduced significantly without decreasing treatment efficacy. Furthermore, as approximately
only half of all patients responds to treatment, there is an urgent need to develop (early)
treatment response prediction markers to select those who benefit from treatment.
Objective: Primary: to investigate the non-inferiority of pembrolizumab 300 mg Q6W versus
pembrolizumab 400 mg Q6W in terms of overall survival. Secondary: to develop biomarkers that
predict immunotherapy treatment response.
Study design: An open label randomized non-inferiority study.
Study population: 750 patients with NSCLC, eligible for treatment with pembrolizumab, in line
with the current ESMO clinical practice guidelines.
Intervention (if applicable): Patients will be randomized to standard of care (400 mg Q6W or
200 mg Q3W dosing of pembrolizumab) versus reduced dose pembrolizumab (300 mg Q6W).
Main study parameters/endpoints: One-year overall survival rate
Phase:
Phase 3
Details
Lead Sponsor:
Radboud University
Collaborator:
Dutch Society of Physicians for Pulmonology and Tuberculosis