217
Participants
Start Date
February 19, 2018
Primary Completion Date
July 31, 2021
Study Completion Date
July 31, 2022
Nivolumab + Ipilimumab
Nivolumab dosed intravenously over 30 minutes at 240 mg every 2 weeks combined with Ipilimumab dosed intravenously over 30 minutes at 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol.
Chemotherapy
Doublet of chemotherapy according to standard of care carboplatin (AUC 5) with a dose that will be capped to 700 mg and pemetrexed (500 mg/m²) over 4 to 6 hours every three weeks (restricted to non-squamous histology) or carboplatin (AUC 6) with a dose that will be capped to 700 mg and paclitaxel (90 mg/m²) D1 D8 D15 over 4 to 6 hours every 4 weeks, with a maximum of 4 cycles of carboplatin based doublet, and the possibility to use maintenance with pemetrexed.
CH du Pays d'Aix, Aix-en-Provence
CHU d'Angers, Angers
CH de Beauvais, Beauvais
CHU de Brest, Brest
Centre Francois Baclesse, Caen
CH René Dubos, Cergy-Pontoise
CH de Charleville-Mézières, Charleville-Mézières
HIA Percy, Clamart
CH Intercommunal, Créteil
CH Intercommunal des Alpes du Sud, Gap
CH Départemental Vendée, La Roche-sur-Yon
CH de Versailles, Le Chesnay
CH Robert Boulin, Libourne
CHU de Limoges, Limoges
CH de Bretagne Sud, Lorient
Centre Léon Bérard, Lyon
CH François Quesnay, Mantes-la-Jolie
APHM Hôpital Nord, Marseille
Hôpital Européen, Marseille
Institut Paoli-Calmette, Marseille
CH de Meaux, Meaux
CH de la Région d'Annecy, Pringy
CHU de Rennes, Rennes
CHU de Rouen, Rouen
CH de Saint-Brieuc, Saint-Brieuc
CHU de Saint-Etienne, Saint-Priest-en-Jarez
CLCC Paul Strauss, Strasbourg
CH Intercommunal Toulon-La Seyne-sur-Mer, Toulon
HIA Saint-Anne, Toulon
CH de Villefranche sur Saône, Villefranche-sur-Saône
Rennes University Hospital
OTHER