Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
CLINIVO
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
1 other identifier
observational
907
1 country
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedMay 24, 2023
May 1, 2023
1.3 years
October 12, 2016
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
time from start of treatment to death from any cause
January 2015 - December 2017
Secondary Outcomes (3)
efficacy of nivolumab
January 2015 - December 2017
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
January 2015 - December 2017
efficacy of the first systemic treatment post-nivolumab
January 2015 - December 2017
Eligibility 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).
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
CH du Pays d'Aix
Aix-en-Provence, France
Clinique du Rambot
Aix-en-Provence, France
CHU d'Amiens-Picardie
Amiens, France
CHU d'Angers
Angers, France
CH Argenteuil
Argenteuil, France
CH d'Avignon
Avignon, France
Institut Sainte Catherine
Avignon, France
CH de la Côte Basque
Bayonne, France
CHU de Besançon
Besançon, France
CH de Blois
Blois, France
Hôpital Avicenne APHP
Bobigny, France
CH Briançon
Briançon, France
Hôpital Pradel HCL
Bron, France
Caen CLCC
Caen, France
CHU de Caen
Caen, France
CH de Pontoise
Cergy-Pontoise, France
CH Métropole Savoie
Chambéry, France
HIA Percy
Clamart, France
Centre Jean Perrin
Clermont-Ferrand, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CH Alpes Léman
Contamine-sur-Arve, France
Clinique des Cèdres
Cornebarrieu, France
CHI de Créteil
Créteil, France
CH de Dax
Dax, France
Centre Georges-François Leclerc
Dijon, France
Institut Daniel Hollard
Grenoble, France
CHR Saint-Omer
Helfaut, France
CHD Vendée
La Roche-sur-Yon, France
CHU Grenoble Alpes
La Tronche, France
CH de Versailles
Le Chesnay, France
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
CH Le Mans
Le Mans, France
CHRU de Lille
Lille, France
CHU de Limoges
Limoges, France
Polyclinique de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
HP Clairval
Marseille, France
Hôpital Nord APHM
Marseille, France
HP Robert Schumann
Metz, France
CH de Mont-De-Masan
Mont-de-Marsan, France
CH de Belfort Montbéliard
Montbéliard, France
GRH Mulhouse Sud-Alsace
Mulhouse, France
Centre d'Oncologie de Gentilly
Nancy, France
Nice CLCC
Nice, France
CHU Nîmes
Nîmes, France
CHR d'Orléans
Orléans, France
Hegp Aphp
Paris, France
HIA Val de Grâce
Paris, France
Hôpital Saint Joseph
Paris, France
Hôpital Saint Louis APHP
Paris, France
Hôpital Tenon APHP
Paris, France
CH de Pau
Pau, France
CHU de Bordeaux
Pessac, France
CH Lyon-Sud HCL
Pierre-Bénite, France
CH de Saint-Brieuc
Saint-Brieuc, France
CHU de Nantes
Saint-Herblain, France
ICO René Gauducheau
Saint-Herblain, France
CH Annecy Genevois
Saint-Julien-en-Genevois, France
HIA Begin
Saint-Mandé, France
ICL Lucien Neuwirth
Saint-Priest-en-Jarez, France
NHC CHRU de Strasbourg
Strasbourg, France
Hôpital Foch
Suresnes, France
CHI Toulon La Seyne Sur Mer
Toulon, France
HIA Saint Anne
Toulon, France
CHU Toulouse
Toulouse, France
CHRU de Tours
Tours, France
Clinique Saint Joseph
Trélazé, France
CH de Valence
Valence, France
CHU Bretagne Atlantique
Vannes, France
Hôpital Nord-Ouest
Villefranche-sur-Saône, France
Gustave Roussy
Villejuif, France
Hôpital Paul Brousse APHP
Villejuif, France
Related Publications (1)
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.
PMID: 34953398RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier MOLINIER, MD
CH Le Mans, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 14, 2016
Study Start
September 1, 2016
Primary Completion
January 1, 2018
Study Completion
December 15, 2020
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share