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Spots Global Cancer Trial Database for Nivolumab and Ipilimumab Versus Chimiotherapy in First Line Treatment in PS 2 or Elderly in Advanced NSCLC Patients

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Hervé Léna

Affiliation: CHU Rennes

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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