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

Non-small Cell Lung Cancer Clinical Trial

— CLINIVO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933346
• Other study ID #: IFCT-1502 CLINIVO
• Status: Completed
• Start date: September 2016
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: December 15, 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Long Term Adverse Effects
• Long-term Adverse Effects
• Lung Neoplasms
• Nivolumab
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
France	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	CHU Grenoble Alpes	La Tronche
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	CHRU de Lille	Lille
France	CHU de Limoges	Limoges
France	Polyclinique de Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Hôpital Nord APHM	Marseille
France	HP Clairval	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

Sponsors (2)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	time from start of treatment to death from any cause	January 2015 - December 2017
Secondary	efficacy of nivolumab	progression-free survival, best overall response, exposure time	January 2015 - December 2017
Secondary	maximum toxicities of nivolumab treatment, including delayed toxicities (immune)	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)	January 2015 - December 2017
Secondary	efficacy of the first systemic treatment post-nivolumab	progression-free survival, best response	January 2015 - December 2017