Pembrolizumab Phase 3 NSCLC Trial Reaches Primary Completion

The Phase 3 PERSEE study (NCT04547504) investigating pembrolizumab for advanced Non-small-cell Lung Cancer (NSCLC) with PDL1 ≥ 50% reached its primary completion on 2025-12-22. This trial compared pembrolizumab alone to a combination of pembrolizumab and chemotherapy as a first-line treatment.

Background

The PERSEE study focuses on Non-small-cell Lung Cancer (NSCLC), specifically in patients with advanced disease characterized by a PDL1 expression of ≥ 50% of tumor cells, and no EGFR mutations or ALK rearrangement. The trial aims to identify optimal first-line treatment strategies for this patient population.

Trial design

The PERSEE study (NCT04547504) is a Phase 3, French national academic study. It enrolled 349 participants with Non-small-cell Lung Cancer (NSCLC) with PDL1 ≥ 50%. The trial compared two intervention arms: pembrolizumab alone versus a combination of pembrolizumab and chemotherapy drugs. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival, as evaluated by an independent review committee.

What this means

The primary completion of the PERSEE study signifies that all planned data collection for the primary endpoint has concluded. Researchers will now proceed with comprehensive data analysis to determine if the combination of pembrolizumab and chemotherapy offers superior progression-free survival compared to pembrolizumab alone in this specific population of advanced NSCLC patients. The results are anticipated to inform future treatment guidelines for first-line therapy in this patient group, potentially impacting clinical practice for individuals with advanced NSCLC and high PDL1 expression.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04547504, titled "PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %," was posted on 2025-12-22 on clinicaltrials.gov.