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Brief Title: Nivolumab and Ipilimumab Versus Chimiotherapy in First Line Treatment in PS 2 or Elderly in Advanced NSCLC Patients
Official Title: Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly (More Than 70 Years Old) Patients With Advanced Non-small Cell Lung Cancer
Study ID: NCT03351361
Brief Summary: Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option. Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy. Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival. In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study. The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CH du Pays d'Aix, Aix-en-Provence, , France
CHU d'Angers, Angers, , France
CH de Beauvais, Beauvais, , France
CHU de Brest, Brest, , France
Centre Francois Baclesse, Caen, , France
CH René Dubos, Cergy-Pontoise, , France
CH de Charleville-Mézières, Charleville-Mézières, , France
HIA Percy, Clamart, , France
CH Intercommunal, Créteil, , France
CH Intercommunal des Alpes du Sud, Gap, , France
CH Départemental Vendée, La Roche-sur-Yon, , France
CH de Versailles, Le Chesnay, , France
CH Robert Boulin, Libourne, , France
CHU de Limoges, Limoges, , France
CH de Bretagne Sud, Lorient, , France
Centre Léon Bérard, Lyon, , France
CH François Quesnay, Mantes-la-Jolie, , France
APHM Hôpital Nord, Marseille, , France
Hôpital Européen, Marseille, , France
Institut Paoli-Calmette, Marseille, , France
CH de Meaux, Meaux, , France
CH de la Région d'Annecy, Pringy, , France
CHU de Rennes, Rennes, , France
CHU de Rouen, Rouen, , France
CH de Saint-Brieuc, Saint-Brieuc, , France
CHU de Saint-Etienne, Saint-Priest-en-Jarez, , France
CLCC Paul Strauss, Strasbourg, , France
CH Intercommunal Toulon-La Seyne-sur-Mer, Toulon, , France
HIA Saint-Anne, Toulon, , France
CH de Villefranche sur Saône, Villefranche-sur-Saône, , France
Name: Hervé Léna
Affiliation: CHU Rennes
Role: PRINCIPAL_INVESTIGATOR