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

Conditions

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

  • France
      • 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 Metropole 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 Créteil
      • Dax, France
        • CH de Dax
      • Dijon, France
        • Centre Georges-Francois Leclerc
      • Grenoble, France
        • Institut Daniel Hollard
      • Helfaut, France
        • CHR Saint-Omer
      • La Tronche, France
        • Chu Grenoble Alpes
      • La-Roche-Sur-Yon, France
        • CHD Vendée
      • Le Chesnay, France
        • CH de Versailles
      • Le Kremlin Bicêtre, France
        • Hôpital Bicêtre 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 Leon Berard
      • 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 Nimes
      • Orléans, France
        • CHR d'Orléans
      • Paris, France
        • Hôpital Tenon APHP
      • Paris, France
        • Hegp Aphp
      • Paris, France
        • HIA Val de Grâce
      • Paris, France
        • Hopital Saint Joseph
      • Paris, France
        • Hôpital 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
        • Hopital 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

16 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.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Bristol-Myers Squibb

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.

General Publications

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.

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