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Spots Global Cancer Trial Database for Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr

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Trial Identification

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

Interventions

Ipilimumab
Nivolumab

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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