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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

349

Participants

Timeline

Start Date

December 22, 2020

Primary Completion Date

December 22, 2025

Study Completion Date

December 22, 2025

Conditions
Non-small-cell Lung Cancer
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."

Trial Locations (29)

13000

Institut Paoli-Calmette, Marseille

13003

Hôpital Européen Marseille, Marseille

13616

CH du Pays d'Aix, Aix-en-Provence

13915

CHU MARSEILLE_ Hopital Nord, Marseille

14000

Centre de lutte contre le cancer - Centre François Baclesse, Caen

29000

Centre Hospitalier de Cornouaille, Quimper

29609

CHRU de Brest, Brest

33604

CHU Bordeaux - Hôpital du Haut Levêque, Pessac

35033

CHU RENNES - Hôpital Pontchailloux, Rennes

42271

SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez

49033

Chu Angers, Angers

56100

CH de Lorient - Hôpital du Scorff, Lorient

67200

Institut de Cancérologie Strasbourg Europe, Strasbourg

69008

Centre Léon Berard, Lyon

69655

Ch Villefranche Sur Saone, Villefranche-sur-Saône

73000

Centre Hospitalier Métropole Savoie, Chambéry

74374

CH d'Annecy-genevois, Pringy

75014

APHP - Hôpital Cochin, Paris

76031

CHU ROUEN - Hôpital Charles Nicolle, Rouen

76503

Saint Aubin Les Elbeuf, Saint-Aubin-lès-Elbeuf

77108

CH MEAUX, Meaux

80054

CHU AMIENS - Hôpital Sud, Amiens

83041

Hôpital d'Instruction des Armées Toulon - Saint Anne, Toulon

85000

CH La Roche Sur Yon - CHD Les Oudairies, La Roche-sur-Yon

87042

Chu Dupuytren, Limoges

94010

CH Intercommunal de Créteil, Créteil

94800

Institut Gustave Roussy, Villejuif

97400

CH La Réunion - Site Félix Guyon, Saint-Denis

97410

CHU La Réunion - Groupe Hospitalier Sud, Saint-Pierre

All Listed Sponsors
collaborator

Groupe Francais De Pneumo-Cancerologie

OTHER

lead

University Hospital, Brest

OTHER