Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
- Conditions
- Non-small Cell Lung CancerLong-term Adverse EffectsNivolumab
- Registration Number
- NCT02933346
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
- Detailed Description
Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use).
Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 907
- All patients with advanced NSCLC, non-eligible for thoracic radiation therapy, having received nivolumab (at least one injection), under nominative or cohort ATU, between 23-JAN-2015 and 31-AUG-2015 (end of ATU).
- patients included in a biomedical research trial with nivolumab
- patients <18 years old
- patients included under ATU to receive nivolumab administration, but never did
- patients with a psychiatric history that hinders the comprehension of the information leaflet
- patients refusing their data being collected
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival January 2015 - December 2017 time from start of treatment to death from any cause
- Secondary Outcome Measures
Name Time Method efficacy of nivolumab January 2015 - December 2017 progression-free survival, best overall response, exposure time
maximum toxicities of nivolumab treatment, including delayed toxicities (immune) January 2015 - December 2017 Maximum toxicity according to the investigator (Adverse events with NCI-CTC 4.0 Grade ≥2, categorized as: hepatic, pulmonary, endocrine, cutaneous, gastrointestinal, renal, hematologic, other immune toxicities)
efficacy of the first systemic treatment post-nivolumab January 2015 - December 2017 progression-free survival, best response
Trial Locations
- Locations (72)
CH du Pays d'Aix
🇫🇷Aix-En-Provence, France
CHU d'Amiens-Picardie
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
CH Argenteuil
🇫🇷Argenteuil, France
Clinique du Rambot
🇫🇷Aix-En-Provence, France
CHU de Besançon
🇫🇷Besançon, France
Hôpital Avicenne APHP
🇫🇷Bobigny, France
Caen CLCC
🇫🇷Caen, France
CH Briançon
🇫🇷Briançon, France
Polyclinique de Limoges
🇫🇷Limoges, France
CH Annecy Genevois
🇫🇷Saint-Julien-en-Genevois, France
NHC CHRU de Strasbourg
🇫🇷Strasbourg, France
CHU Bretagne Atlantique
🇫🇷Vannes, France
Hôpital Nord-Ouest
🇫🇷Villefranche-Sur-Saône, France
Hôpital Paul Brousse APHP
🇫🇷Villejuif, France
Gustave Roussy
🇫🇷Villejuif, France
Centre Léon Bérard
🇫🇷Lyon, France
HIA Begin
🇫🇷Saint-Mandé, France
CH de Pau
🇫🇷Pau, France
ICO René Gauducheau
🇫🇷Saint-Herblain, France
CH Lyon-Sud HCL
🇫🇷Pierre-Bénite, France
CHU de Nantes
🇫🇷Saint-Herblain, France
Hôpital Nord APHM
🇫🇷Marseille, France
Hôpital Saint Joseph
🇫🇷Paris, France
CH de Saint-Brieuc
🇫🇷Saint-Brieuc, France
Hôpital Tenon APHP
🇫🇷Paris, France
CHU de Bordeaux
🇫🇷Pessac, France
Hôpital Saint Louis APHP
🇫🇷Paris, France
ICL Lucien Neuwirth
🇫🇷Saint-Priest-en-Jarez, France
CH de Valence
🇫🇷Valence, France
CHRU de Tours
🇫🇷Tours, France
HIA Saint Anne
🇫🇷Toulon, France
Hôpital Foch
🇫🇷Suresnes, France
CHU Toulouse
🇫🇷Toulouse, France
CHI Toulon La Seyne Sur Mer
🇫🇷Toulon, France
Clinique Saint Joseph
🇫🇷Trélazé, France
CH d'Avignon
🇫🇷Avignon, France
Institut Sainte Catherine
🇫🇷Avignon, France
CH de Blois
🇫🇷Blois, France
CH de la Côte Basque
🇫🇷Bayonne, France
CH de Pontoise
🇫🇷Cergy Pontoise, France
CHU de Caen
🇫🇷Caen, France
Hôpital Pradel HCL
🇫🇷Bron, France
CH de Dax
🇫🇷Dax, France
HIA Percy
🇫🇷Clamart, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CH Métropole Savoie
🇫🇷Chambéry, France
Clinique des Cèdres
🇫🇷Cornebarrieu, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CH Alpes Léman
🇫🇷Contamine Sur Arve, France
CHI de Créteil
🇫🇷Créteil, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Institut Daniel Hollard
🇫🇷Grenoble, France
CHU Grenoble Alpes
🇫🇷La Tronche, France
CHR Saint-Omer
🇫🇷Helfaut, France
CHD Vendée
🇫🇷La-Roche-Sur-Yon, France
CH de Versailles
🇫🇷Le Chesnay, France
Hôpital Bicêtre APHP
🇫🇷Le Kremlin Bicêtre, France
CH Le Mans
🇫🇷Le Mans, France
CHU de Limoges
🇫🇷Limoges, France
CHRU de Lille
🇫🇷Lille, France
HP Robert Schumann
🇫🇷Metz, France
HP Clairval
🇫🇷Marseille, France
CH de Belfort Montbéliard
🇫🇷Montbéliard, France
CH de Mont-De-Masan
🇫🇷Mont-De-Marsan, France
GRH Mulhouse Sud-Alsace
🇫🇷Mulhouse, France
Nice CLCC
🇫🇷Nice, France
Centre d'Oncologie de Gentilly
🇫🇷Nancy, France
CHU Nîmes
🇫🇷Nîmes, France
CHR d'Orléans
🇫🇷Orléans, France
Hegp Aphp
🇫🇷Paris, France
HIA Val de Grâce
🇫🇷Paris, France