LOREA : ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH NON INTERVENTIONAL STUDY
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients (male or female) 18 years of age or older at age inclusion
• Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH positive/transcriptomic method)
• Complete radiological evaluation has to be performed before the start of lorlatinib by contrast enhanced CT-scan of thorax and upper abdomen and brain MRI, as per routine care
• Patients with ECOG performance status grade 0, 1, or 2
Locations
Other Locations
France
Centre Hospitalier du Pays d AIX
RECRUITING
Aix-en-provence
CH ALBI
RECRUITING
Albi
Chu Amiens Sud
RECRUITING
Amiens
Ch Avignon
NOT_YET_RECRUITING
Avignon
Institut Bergonie
NOT_YET_RECRUITING
Bordeaux
Polyclinique Bordeaux Nord Aquitaine
NOT_YET_RECRUITING
Bordeaux
Hopital Morvan
NOT_YET_RECRUITING
Brest
CHIC
RECRUITING
Créteil
Clcc Georges Francois Leclerc
RECRUITING
Dijon
Hopital de Villefranche Sur Saone
NOT_YET_RECRUITING
Gleizé
Chu Limoges
RECRUITING
Limoges
Centre Leon Berard
NOT_YET_RECRUITING
Lyon
Hopital Robert Schuman de Vantoux
RECRUITING
Metz
CHRU de Nancy
NOT_YET_RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
Hopital Cochin
NOT_YET_RECRUITING
Paris
Hopital Europeen Georges Pompidou
RECRUITING
Paris
Hopital Saint Joseph
RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Centre Hospitalier Francois Mitterand
RECRUITING
Pau
Ch Annecy Genevois
RECRUITING
Pringy
Ch Cornouaille
RECRUITING
Quimper
Institut Godinot
RECRUITING
Reims
Hopital Pontchaillou
RECRUITING
Rennes
Hopital Foch
RECRUITING
Suresnes
Chits Ch Sainte Musse
NOT_YET_RECRUITING
Toulon
CHRU Bretonneau
RECRUITING
Tours
Ch Troyes
RECRUITING
Troyes
Hopital de Rangueil
RECRUITING
Tsa 50032 Toulouse
Clinique Teissier
RECRUITING
Valenciennes
CHBA
RECRUITING
Vannes
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 90
Treatments
Experimental: Lorlatinib
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
Related Therapeutic Areas
Sponsors
Leads: Pfizer