drugset / Trial / NCT04547504

PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %

NCT04547504 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.

Timeline

Start
2020-12-22
Primary completion
2025-12-22
Completion
2025-12-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown —
Comparator Carboplatin Small molecule 6 unknown —
Comparator Cisplatin Other / unclassified 75 mg/m2 —
Comparator Pembrolizumab Monoclonal antibody 200 mg —
Comparator Pembrolizumab Monoclonal antibody 200 mg/m2 —
Comparator Pemetrexed Small molecule 500 mg/m2 —