Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program

NCT ID: NCT02933346

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 907 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-12-15

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.

Conditions

Non-small Cell Lung Cancer; Nivolumab; Long-term Adverse Effects

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier MOLINIER, MD

Role: PRINCIPAL_INVESTIGATOR

CH Le Mans, France

Locations

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

Countries

France

References

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.

Reference Type: RESULT

PMID: 34953398 (View on PubMed)

Other Identifiers

IFCT-1502 CLINIVO

Identifier Type: -

Identifier Source: org_study_id