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Brief Title: Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr
Official Title: A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet Immunotherapy Until Progression Versus Observation in Treatment-naive Patients With PDL1-positive Stage IV Non-Small Cell Lung Cancer (NSCLC) After Nivolumab-Ipilimumab Induction Treatment
Study ID: NCT03469960
Brief Summary: Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World. For the patients presenting a NSCLC stage IV, the median of survival is about 15 months today. The chemotherapy with platinum is the standard treatment for these patients but immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses and long survivals have been described in patients having interrupted the treatment. In the melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of the study is to demonstrate that a treatment of 6 months followed by an observation (stop and go) is not less effective than a treatment given until progression or toxicity. This strategy would allow to decrease the accumulated toxicities, to improve the quality of life of the patients and to decrease the costs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Amiens - CHU, Amiens, , France
Angers - CHU, Angers, , France
Annecy - CH, Annecy, , France
Argenteuil -CH, Argenteuil, , France
Avignon - CH, Avignon, , France
Bordeaux - Polyclinique Nord, Bordeaux, , France
Boulogne - Ambroise Paré, Boulogne-Billancourt, , France
Caen - CHU Côte de Nacre, Caen, , France
Cahors - CH, Cahors, , France
CH de Pontoise, Cergy Pontoise, , France
CH Chambery, Chambery, , France
CH de Chauny, Chauny, , France
CH, Cholet, , France
Clamart - Hôpital Percy, Clamart, , France
Clermont Ferrand - CHU, Clermont Ferrand, , France
Colmar - CH, Colmar, , France
Dijon - CAC, Dijon, , France
CHRU Grenoble, Grenoble, , France
La Roche Sur Yon - CH, La Roche Sur Yon, , France
Centre Hospitalier - Pneumologie, Le Mans, , France
CHRU de Lille, Lille, , France
CHU de Limoges, Limoges, , France
CH Lyon Sud - Pneumologie, Lyon, , France
Institut Paoli Calmette, Marseille, , France
Marseille - Hôpital Européen, Marseille, , France
Mont de Marsan - CH, Mont de Marsan, , France
Mulhouse - CH, Mulhouse, , France
Nantes - Centre René Gauducheau, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
CHU Nîmes, Nîmes, , France
Orléans - CH, Orléans, , France
AP-HP Hopital Tenon - Pneumologie, Paris, , France
AP-HP Hôpital Bichat, Paris, , France
GH Paris Saint-Joseph, Paris, , France
Hôpital Saint Louis APHP, Paris, , France
Paris - Institut Curie, Paris, , France
Rouen - CHU, Rouen, , France
Saint Quentin - CH, Saint Quentin, , France
Centre René Huguenin, Saint-Cloud, , France
HIA Begin, Saint-Mandé, , France
ICL Lucien Neuwirth, Saint-Priest-en-Jarez, , France
Suresnes - Hopital Foch, Suresnes, , France
Toulon - CHI, Toulon, , France
CHU Toulouse, Toulouse, , France
CHRU de Tours, Tours, , France
Versailles - CH, Versailles, , France
CH de Villefranche - Pneumologie, Villefranche, , France