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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | time from start of treatment to death from any cause | January 2015 - December 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of nivolumab | progression-free survival, best overall response, exposure time | January 2015 - December 2017 |
| maximum toxicities of nivolumab treatment, including delayed toxicities (immune) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Olivier MOLINIER, MD | CH Le Mans, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH du Pays d'Aix | Aix-en-Provence | France | ||||
| Clinique du Rambot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34953398 | Result | 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. |
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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 | progression-free survival, best response | January 2015 - December 2017 |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000069451 | Long Term Adverse Effects |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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