drugset / Trial / NCT04547504
PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %
Phase 3
Active not recruiting
349 enrolled
University Hospital, Brest
Groupe Francais De Pneumo-Cancerologie · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |