Non-small Cell Lung CancerCLINIVONCT02933346
Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program
An observational study of Non-small Cell Lung Cancer and Nivolumab, run by Intergroupe Francophone de Cancerologie Thoracique at 72 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Nivolumab, Long-term Adverse Effects
- How many people
- 907 participants
- Where
- 72 sitesFrance
- Study dates
- Sep 2016to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
France72 sites
CH du Pays d'Aix
Aix-en-Provence
Clinique du Rambot
Aix-en-Provence
CHU d'Amiens-Picardie
Amiens
CHU d'Angers
Angers
CH Argenteuil
Argenteuil
CH d'Avignon
Avignon
Institut Sainte Catherine
Avignon
CH de la Côte Basque
Bayonne
CHU de Besançon
Besançon
CH de Blois
Blois
Hôpital Avicenne APHP
Bobigny
CH Briançon
Briançon
Hôpital Pradel HCL
Bron
Caen CLCC
Caen
CHU de Caen
Caen
CH de Pontoise
Cergy-Pontoise
CH Métropole Savoie
Chambéry
HIA Percy
Clamart
Centre Jean Perrin
Clermont-Ferrand
CHU de Clermont-Ferrand
Clermont-Ferrand
CH Alpes Léman
Contamine-sur-Arve
Clinique des Cèdres
Cornebarrieu
CHI de Créteil
Créteil
CH de Dax
Dax
Centre Georges-François Leclerc
Dijon
Institut Daniel Hollard
Grenoble
CHR Saint-Omer
Helfaut
CHD Vendée
La Roche-sur-Yon
CHU Grenoble Alpes
La Tronche
CH de Versailles
Le Chesnay
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre
CH Le Mans
Le Mans
CHRU de Lille
Lille
CHU de Limoges
Limoges
Polyclinique de Limoges
Limoges
Centre Léon Bérard
Lyon
HP Clairval
Marseille
Hôpital Nord APHM
Marseille
HP Robert Schumann
Metz
CH de Mont-De-Masan
Mont-de-Marsan
CH de Belfort Montbéliard
Montbéliard
GRH Mulhouse Sud-Alsace
Mulhouse
Centre d'Oncologie de Gentilly
Nancy
Nice CLCC
Nice
CHU Nîmes
Nîmes
CHR d'Orléans
Orléans
Hegp Aphp
Paris
HIA Val de Grâce
Paris
Hôpital Saint Joseph
Paris
Hôpital Saint Louis APHP
Paris
Hôpital Tenon APHP
Paris
CH de Pau
Pau
CHU de Bordeaux
Pessac
CH Lyon-Sud HCL
Pierre-Bénite
CH de Saint-Brieuc
Saint-Brieuc
CHU de Nantes
Saint-Herblain
ICO René Gauducheau
Saint-Herblain
CH Annecy Genevois
Saint-Julien-en-Genevois
HIA Begin
Saint-Mandé
ICL Lucien Neuwirth
Saint-Priest-en-Jarez
NHC CHRU de Strasbourg
Strasbourg
Hôpital Foch
Suresnes
CHI Toulon La Seyne Sur Mer
Toulon
HIA Saint Anne
Toulon
CHU Toulouse
Toulouse
CHRU de Tours
Tours
Clinique Saint Joseph
Trélazé
CH de Valence
Valence
CHU Bretagne Atlantique
Vannes
Hôpital Nord-Ouest
Villefranche-sur-Saône
Gustave Roussy
Villejuif
Hôpital Paul Brousse APHP
Villejuif
About this study
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
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.
Read the 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.
- Keywords
- Nivolumab, Real-world study, IFCT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Long Term Adverse Effects
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
time from start of treatment to death from any cause
Measured: January 2015 - December 2017
Secondary outcomes (3)
efficacy of nivolumab
progression-free survival, best overall response, exposure time
Measured: January 2015 - December 2017
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)
Measured: January 2015 - December 2017
efficacy of the first systemic treatment post-nivolumab
progression-free survival, best response
Measured: January 2015 - December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Olivier MOLINIER, MD, Principal investigator, CH Le Mans, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933346
- Sponsor's protocol ID
- IFCT-1502 CLINIVO
- Acronym
- CLINIVO
- Status last verified
- May 2023
- First submitted
- 12 Oct 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34953398
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02933346
- Acronym / sponsor ID
- CLINIVO / IFCT-1502 CLINIVO
- Keywords
- Nivolumab, Real-world study, IFCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: January 2015 - December 2017
time from start of treatment to death from any cause
3 secondary outcomes
efficacy of nivolumab
Time frame: January 2015 - December 2017
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)
Time frame: January 2015 - December 2017
efficacy of the first systemic treatment post-nivolumab
Time frame: January 2015 - December 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 34953398Molinier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier MOLINIER, MD principal investigator
CH Le Mans, France
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Nivolumab, run by Intergroupe Francophone de Cancerologie Thoracique at 72 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: January 2015 - December 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.