Clinical trial NCT02933346: Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
Official title: Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Nivolumab
Long-term Adverse Effects
Keywords: Nivolumab
Real-world study
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-10-14
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: overall survival
timeFrame: January 2015 - December 2017
Secondary outcomes:
measure: efficacy of nivolumab
timeFrame: January 2015 - December 2017
measure: maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
timeFrame: January 2015 - December 2017
measure: efficacy of the first systemic treatment post-nivolumab
timeFrame: January 2015 - December 2017
Other outcomes:
Locations:
city: Aix-En-Provence
country: France
facility: CH du Pays d'Aix
city: Aix-En-Provence
country: France
facility: Clinique du Rambot
city: Amiens
country: France
facility: CHU d'Amiens-Picardie
city: Angers
country: France
facility: CHU d'Angers
city: Argenteuil
country: France
facility: CH Argenteuil
city: Avignon
country: France
facility: CH d'Avignon
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besançon
country: France
facility: CHU de Besançon
city: Blois
country: France
facility: CH de Blois
city: Bobigny
country: France
facility: Hôpital Avicenne APHP
city: Briançon
country: France
facility: CH Briançon
city: Bron
country: France
facility: Hôpital Pradel HCL
city: Caen
country: France
facility: Caen CLCC
city: Caen
country: France
facility: CHU de Caen
city: Cergy Pontoise
country: France
facility: CH de Pontoise
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Clamart
country: France
facility: HIA Percy
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Contamine Sur Arve
country: France
facility: CH Alpes Léman
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Créteil
country: France
facility: CHI de Créteil
city: Dax
country: France
facility: CH de Dax
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: Helfaut
country: France
facility: CHR Saint-Omer
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: La-Roche-Sur-Yon
country: France
facility: CHD Vendée
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre APHP
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Limoges
country: France
facility: Polyclinique de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: HP Clairval
city: Marseille
country: France
facility: Hôpital Nord APHM
city: Metz
country: France
facility: HP Robert Schumann
city: Mont-De-Marsan
country: France
facility: CH de Mont-De-Masan
city: Montbéliard
country: France
facility: CH de Belfort Montbéliard
city: Mulhouse
country: France
facility: GRH Mulhouse Sud-Alsace
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Nice
country: France
facility: Nice CLCC
city: Nîmes
country: France
facility: CHU Nîmes
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: Hegp Aphp
city: Paris
country: France
facility: HIA Val de Grâce
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: Hôpital Saint Louis APHP
city: Paris
country: France
facility: Hôpital Tenon APHP
city: Pau
country: France
facility: CH de Pau
city: Pessac
country: France
facility: CHU de Bordeaux
city: Pierre-Bénite
country: France
facility: CH Lyon-Sud HCL
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Saint-Herblain
country: France
facility: CHU de Nantes
city: Saint-Herblain
country: France
facility: ICO René Gauducheau
city: Saint-Julien-en-Genevois
country: France
facility: CH Annecy Genevois
city: Saint-Mandé
country: France
facility: HIA Begin
city: Saint-Priest-en-Jarez
country: France
facility: ICL Lucien Neuwirth
city: Strasbourg
country: France
facility: NHC CHRU de Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: CHI Toulon La Seyne Sur Mer
city: Toulon
country: France
facility: HIA Saint Anne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU de Tours
city: Trélazé
country: France
facility: Clinique Saint Joseph
city: Valence
country: France
facility: CH de Valence
city: Vannes
country: France
facility: CHU Bretagne Atlantique
city: Villefranche-Sur-Saône
country: France
facility: Hôpital Nord-Ouest
city: Villejuif
country: France
facility: Gustave Roussy
city: Villejuif
country: France
facility: Hôpital Paul Brousse APHP
Study officials:
affiliation: CH Le Mans, France
name: Olivier MOLINIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molinier O, Besse B, Barlesi F, Audigier-Valette C, Friard S, Monnet I, Jeannin G, Mazieres J, Cadranel J, Hureaux J, Hilgers W, Quoix E, Coudert B, Moro-Sibilot D, Fauchon E, Westeel V, Brun P, Langlais A, Morin F, Souquet PJ, Girard N. IFCT-1502 CLINIVO: real-world evidence of long-term survival with nivolumab in a nationwide cohort of patients with advanced non-small-cell lung cancer. ESMO Open. 2022 Feb;7(1):100353. doi: 10.1016/j.esmoop.2021.100353. Epub 2021 Dec 23.