Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program (CLINIVO)
May 23, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique
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
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
907
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aix-En-Provence, France
- CH du Pays D'Aix
-
Aix-En-Provence, France
- Clinique du Rambot
-
Amiens, France
- CHU d'Amiens-Picardie
-
Angers, France
- CHU d'Angers
-
Argenteuil, France
- CH Argenteuil
-
Avignon, France
- Institut Sainte Catherine
-
Avignon, France
- CH d'Avignon
-
Bayonne, France
- CH de la Côte Basque
-
Besançon, France
- CHU De Besancon
-
Blois, France
- CH de Blois
-
Bobigny, France
- Hôpital Avicenne APHP
-
Briançon, France
- CH Briançon
-
Bron, France
- Hôpital Pradel HCL
-
Caen, France
- CHU de Caen
-
Caen, France
- Caen CLCC
-
Cergy Pontoise, France
- CH de Pontoise
-
Chambéry, France
- CH métropole Savoie
-
Clamart, France
- HIA Percy
-
Clermont-Ferrand, France
- Centre Jean Perrin
-
Clermont-Ferrand, France
- Chu de Clermont-Ferrand
-
Contamine Sur Arve, France
- CH Alpes Léman
-
Cornebarrieu, France
- Clinique des Cèdres
-
Créteil, France
- Chi De Creteil
-
Dax, France
- CH de Dax
-
Dijon, France
- Centre Georges-François Leclerc
-
Grenoble, France
- Institut Daniel Hollard
-
Helfaut, France
- CHR Saint-Omer
-
La Tronche, France
- Chu Grenoble Alpes
-
La-Roche-Sur-Yon, France
- CHD Vendee
-
Le Chesnay, France
- CH de Versailles
-
Le Kremlin Bicêtre, France
- Hopital Bicetre Aphp
-
Le Mans, France
- CH Le Mans
-
Lille, France
- CHRU de Lille
-
Limoges, France
- CHU de Limoges
-
Limoges, France
- Polyclinique de Limoges
-
Lyon, France
- Centre Léon Bérard
-
Marseille, France
- Hopital Nord APHM
-
Marseille, France
- HP Clairval
-
Metz, France
- HP Robert Schumann
-
Mont-De-Marsan, France
- CH de Mont-De-Masan
-
Montbéliard, France
- CH de Belfort Montbéliard
-
Mulhouse, France
- GRH Mulhouse Sud-Alsace
-
Nancy, France
- Centre D'Oncologie de Gentilly
-
Nice, France
- Nice CLCC
-
Nîmes, France
- CHU Nîmes
-
Orléans, France
- Chr D'Orleans
-
Paris, France
- Hôpital Tenon APHP
-
Paris, France
- Hegp Aphp
-
Paris, France
- HIA Val de Grâce
-
Paris, France
- Hopital Saint Joseph
-
Paris, France
- Hopital Saint Louis APHP
-
Pau, France
- CH de Pau
-
Pessac, France
- CHU de BORDEAUX
-
Pierre-Bénite, France
- CH Lyon-Sud HCL
-
Saint-Brieuc, France
- CH de Saint-Brieuc
-
Saint-Herblain, France
- CHU de Nantes
-
Saint-Herblain, France
- ICO René Gauducheau
-
Saint-Julien-en-Genevois, France
- CH Annecy Genevois
-
Saint-Mandé, France
- HIA Begin
-
Saint-Priest-en-Jarez, France
- ICL Lucien Neuwirth
-
Strasbourg, France
- NHC CHRU de Strasbourg
-
Suresnes, France
- Hôpital Foch
-
Toulon, France
- CHI Toulon La Seyne Sur Mer
-
Toulon, France
- Hia Saint Anne
-
Toulouse, France
- CHU Toulouse
-
Tours, France
- CHRU de Tours
-
Trélazé, France
- Clinique Saint Joseph
-
Valence, France
- CH de Valence
-
Vannes, France
- CHU Bretagne Atlantique
-
Villefranche-Sur-Saône, France
- Hôpital Nord-Ouest
-
Villejuif, France
- Gustave Roussy
-
Villejuif, France
- Hôpital Paul Brousse APHP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: January 2015 - December 2017
|
time from start of treatment to death from any cause
|
January 2015 - December 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy of nivolumab
Time Frame: January 2015 - December 2017
|
progression-free survival, best overall response, exposure time
|
January 2015 - December 2017
|
|
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
Time Frame: 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)
|
January 2015 - December 2017
|
|
efficacy of the first systemic treatment post-nivolumab
Time Frame: January 2015 - December 2017
|
progression-free survival, best response
|
January 2015 - December 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Olivier MOLINIER, MD, CH Le Mans, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
December 15, 2020
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 14, 2016
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFCT-1502 CLINIVO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.