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Spots Global Cancer Trial Database for Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

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Trial Identification

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

Interventions

Lorlatinib

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Michael Duruisseaux

Affiliation: Lyon - URCOT

Role: STUDY_CHAIR

Name: Denis Moro-Sibilot

Affiliation: Grenoble - CHU

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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