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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: David PLANCHARD
Affiliation: Intergroupe Francophone de Cancerologie Thoracique
Role: PRINCIPAL_INVESTIGATOR
Name: Franck MORIN
Affiliation: Intergroupe Francophone de Cancerologie Thoracique
Role: STUDY_DIRECTOR