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Brief Title: Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer
Official Title: A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer
Study ID: NCT04111705
Brief Summary: Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Angers - CHU, Angers, , France
Annecy - CH, Annecy, , France
Bayonne - CH, Bayonne, , France
Besançon - CHU, Besançon, , France
Bordeaux - CHU Hôpital Haut-Lévèque, Bordeaux, , France
Boulogne - Ambroise Paré, Boulogne-Billancourt, , France
Caen - CHU Côte de Nacre, Caen, , France
Colmar - CH, Colmar, , France
Créteil - CHI, Créteil, , France
Dijon - CRLCC, Dijon, , France
Grenoble - CHU, Grenoble, , France
Le Mans - CHG, Le Mans, , France
Lille - Hôpital Calmette, Lille, , France
Lyon - CRLCC, Lyon, , France
Marseille - AP-HM Hôpital Nord, Marseille, , France
Marseille - Institut Paoli Calmette, Marseille, , France
Montpellier - CHU, Montpellier, , France
Montpellier - Clinique, Montpellier, , France
Mulhouse - GHRMSA, Mulhouse, , France
Nantes - CRLCC, Nantes, , France
Orléans - CHR, Orléans, , France
Paris - APHP - Hopital Tenon, Paris, , France
Paris - APHP Bichat, Paris, , France
Paris - Curie, Paris, , France
Paris - Hôpital Cochin, Paris, , France
Lyon - URCOT, Pierre-Bénite, , France
Saint Quentin - CH, Saint Quentin, , France
Strasbourg - Nouvel Hôpital Civil, Strasbourg, , France
Suresnes - Hopital Foch, Suresnes, , France
Toulon - CHI, Toulon, , France
Toulouse - CHU, Toulouse, , France
Vandoeuvre-lès-Nancy - CRLCC, Vandoeuvre-lès-Nancy, , France
Name: Michael Duruisseaux
Affiliation: Lyon - URCOT
Role: STUDY_CHAIR
Name: Denis Moro-Sibilot
Affiliation: Grenoble - CHU
Role: STUDY_CHAIR