NVALT30/DEDICATION-1

Rationale: Immune checkpoint inhibitors have been 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 standard dose versus a reduced dose. 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 versus reduced dose pembrolizumab.

Main study parameters/endpoints: One-year overall survival rate