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PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %
Sponsor: University Hospital, Brest
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
Conditions
Interventions
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.
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