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Spots Global Cancer Trial Database for Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

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Trial Identification

Brief Title: Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

Official Title: A Phase II Single-group Assignment, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Tyrosine Kinase Inhibitor in Patients With Advanced ROS1-positive Non-small Cell Lung Cancer (ALBATROS)

Study ID: NCT04621188

Interventions

Lorlatinib

Study Description

Brief Summary: ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies. Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion. However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors. Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Hospitalier du Pays d'Aix, Aix-en-Provence, , France

Centre Paul Papin, Angers, , France

Angers - CHU, Angers, , France

Annecy - CH, Annecy, , France

Antony - Hôpital privé, Antony, , France

Avignon - CH, Avignon, , France

Centre Hospitalier de la Côte Basque, Bayonne, , France

Bordeaux - CHU, Bordeaux, , France

Bordeaux - Institut Bergonie, Bordeaux, , France

Bordeaux - Polyclinique, Bordeaux, , France

AP-HP Hôpital Ambroise Paré, Boulogne, , France

Caen - CHU Côte de Nacre, Caen, , France

Chauny - CH, Chauny, , France

Cholet - CH, Cholet, , France

Clermont-Ferrand - CHU, Clermont-Ferrand, , France

Colmar - CH, Colmar, , France

Centre Hospitalier Intercommunal de Créteil, Créteil, , France

Dijon - CRLCC, Dijon, , France

CHRU Grenoble, Grenoble, , France

Centre Hospitalier - Pneumologie, Le Mans, , France

Hôpital Calmette, Lille, , France

Centre Léon Bérard, Lyon, , France

Institut Paoli Calmettes, Marseille, , France

Marseille Hôpital Nord, Marseille, , France

GRH Mulhouse Sud-Alsace, Mulhouse, , France

AP-HP Hôpital Cochin, Paris, , France

AP-HP Hopital Tenon - Pneumologie, Paris, , France

AP-HP Hôpital Bichat, Paris, , France

Paris - Curie, Paris, , France

Lyon - URCOT, Pierre-Bénite, , France

Rouen - CHU, Rouen, , France

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

Hôpital Foch, Suresnes, , France

CHU Toulouse - Pneumologie, Toulouse, , France

CHU Bretonneau, Tours, , France

Valenciennes - Clinique, Valenciennes, , France

Vandoeuvre-lès-Nancy - CHU, Vandœuvre-lès-Nancy, , France

Gustave Roussy, Villejuif, , France

Contact Details

Name: Denis Moro-Sibilot

Affiliation: Grenoble - CHU

Role: STUDY_CHAIR

Name: Michael Duruisseaux

Affiliation: Lyon - URCOT

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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