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ACTIVE NOT RECRUITING
NCT04547504
PHASE3

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

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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.

Official title: Randomized, Open-label, Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers (NSCLC) With PDL1 Expression ≥50%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

349

Start Date

2020-12-22

Completion Date

2025-12-22

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.

DRUG

Pembrolizumab and Chemotherapy drugs

An induction therapy followed by a maintenance therapy. 4 induction cycles every 3 weeks associating, on the first day of each cycle: * Cisplatin 75mg/m² or carboplatin AUC 5mg/mL/min, pemetrexed 500mg/m² and pembrolizumab 200mg for non squamous NSCLC. * Carboplatin AUC 6mg/mL/min, paclitaxel 200mg/m² and pembrolizumab 200mg for squamous NSCLC. After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable: * Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy. * Squamous NSCLC: pembrolizumab monotherapy. For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop. For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

Locations (29)

CH du Pays d'Aix

Aix-en-Provence, France

CHU AMIENS - Hôpital Sud

Amiens, France

Chu Angers

Angers, France

CHRU de Brest

Brest, France

Centre de lutte contre le cancer - Centre François Baclesse

Caen, France

Centre Hospitalier Métropole Savoie

Chambéry, France

CH Intercommunal de Créteil

Créteil, France

CH La Roche Sur Yon - CHD Les Oudairies

La Roche-sur-Yon, France

Chu Dupuytren

Limoges, France

CH de Lorient - Hôpital du Scorff

Lorient, France

Centre Léon Berard

Lyon, France

Institut Paoli-Calmette

Marseille, France

Hôpital Européen Marseille

Marseille, France

CHU MARSEILLE_ Hopital Nord

Marseille, France

CH MEAUX

Meaux, France

APHP - Hôpital Cochin

Paris, France

CHU Bordeaux - Hôpital du Haut Levêque

Pessac, France

CH d'Annecy-genevois

Pringy, France

Centre Hospitalier de Cornouaille

Quimper, France

CHU RENNES - Hôpital Pontchailloux

Rennes, France

CHU ROUEN - Hôpital Charles Nicolle

Rouen, France

Saint Aubin Les Elbeuf

Saint-Aubin-lès-Elbeuf, France

CH La Réunion - Site Félix Guyon

Saint-Denis, France

CHU La Réunion - Groupe Hospitalier Sud

Saint-Pierre, France

SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, France

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

Hôpital d'Instruction des Armées Toulon - Saint Anne

Toulon, France

Ch Villefranche Sur Saone

Villefranche-sur-Saône, France

Institut Gustave Roussy

Villejuif, France