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Spots Global Cancer Trial Database for Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

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Trial Identification

Brief Title: Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

Official Title: A Phase II, Multi-centre Study, to Evaluate the Efficacy and Safety of Osimertinib Treatment for Patients With EGFR-mutated Non-small Cell Lung Cancer (NSCLC) With Brain or Leptomeningeal Metastases

Study ID: NCT04233021

Interventions

Osimertinib

Study Description

Brief Summary: Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment. In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication. Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Hospitalier Aix-Pertuis, Aix-en-Provence, , France

CHU Amiens - Groupe Hospitalier Sud, Amiens, , France

Centre Paul Papin, Angers, , France

Hôpital privé d'Antony, Antony, , France

Institut Sainte Catherine, Avignon, , France

Centre Hospitalier de la Côte Basque, Bayonne, , France

CHU Besançon - Hôpital J. MINJOZ, Besançon, , France

Groupe Hospitalier Saint André, Bordeaux, , France

AP-HP Hôpital Ambroise Paré, Boulogne, , France

CHU Côte de Nacre, Caen, , France

Hôpital Louis Pasteur, Colmar, , France

Centre Hospitalier Intercommunal de Créteil, Créteil, , France

CHU Hôpital du Bocage, Dijon, , France

Chu Grenoble, Grenoble, , France

Centre Hospitalier Général, Le Mans, , France

Hôpital Calmette, Lille, , France

CHU Dupuytren, Limoges, , France

Institut Paoli Calmettes, Marseille, , France

Marseille Hôpital Nord, Marseille, , France

CHU Montpellier, Montpellier, , France

Centre Hospitalier Régional - Hôpital de la Source, Orléans, , France

AP-HP Hôpital Cochin, Paris, , France

AP-HP Hôpital Bichat, Paris, , France

Centre Hospitalier Général - Pau, Pau, , France

Lyon - URCOT Centre Hospitalier Universitaire, Pierre-Bénite, , France

CHU de la Réunion - Site Felix Guyon, Saint-Denis, , France

Institut de Cancérologie de l'Ouest - René Gauducheau, Saint-Herblain, , France

CHU de La Réunion-Site Sud, Saint-Pierre, , France

Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg, Strasbourg, , France

Hôpital Foch, Suresnes, , France

HIA Sainte-Anne, Toulon, , France

Hôpital Larrey, Toulouse, , France

CHU Bretonneau, Tours, , France

Valenciennes Clinique PRIV, Valenciennes, , France

Centre Hospitalier de Villefranche-sur-Saône, Villefranche-sur-Saône, , France

Gustave Roussy, Villejuif, , France

Contact Details

Name: David PLANCHARD

Affiliation: Intergroupe Francophone de Cancerologie Thoracique

Role: PRINCIPAL_INVESTIGATOR

Name: Franck MORIN

Affiliation: Intergroupe Francophone de Cancerologie Thoracique

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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