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

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.

NCT Number	NCT04547504
Lead Sponsor	University Hospital, Brest Collaborators: Groupe Francais De Pneumo-Cancerologie
Conditions	Non-small-cell Lung Cancer
Enrollment	349 participants
Start Date	2020-12-22
Primary Completion	2025-12-22 (estimated)
Study Completion	2025-12-22 (estimated)
Updated on ClinicalTrials.gov	2025-09-17