Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
LORLATU
1 other identifier
observational
291
1 country
30
Brief Summary
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedMay 24, 2023
May 1, 2023
1.7 years
October 29, 2018
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
time from first dose of treatment to first occurrence of disease progression or death from any cause during the study
October 2015 - December 2019
Secondary Outcomes (9)
Best response
October 2015 - December 2019
Duration of treatment
October 2015 - December 2019
Pattern of tumor progression
October 2015 - December 2019
Reason for treatment discontinuation
October 2015 - December 2019
Duration of treatment beyond progression
October 2015 - December 2019
- +4 more secondary outcomes
Eligibility Criteria
Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program). Selection period would start at October 2015 (e.g.,initiation of lorlatinib treatment)
You may qualify if:
- Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer \[AJCC\] classification) at time of lorlatinib initiation
- Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
You may not qualify if:
- Patients enrolled in a lorlatinib clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intergroupe Francophone de Cancerologie Thoraciquelead
- Pfizercollaborator
Study Sites (30)
Aix-en-Provence - CH
Aix-en-Provence, France
Angers - CHU
Angers, France
Annemasse - CH
Annemasse, France
Avignon - CH
Avignon, France
Bordeaux - Polyclinique
Bordeaux, France
Brest - Morvan CHU
Brest, France
Cahors - CH
Cahors, France
Chartres-CH
Chartres, France
Clermont-Ferrand - CHU
Clermont-Ferrand, France
Colmar - CH
Colmar, France
Créteil - CHI
Créteil, France
La Roche-Sur-Yon - CH
La Roche-sur-Yon, France
Libourne - CH
Libourne, France
Lorient - CHBS
Lorient, France
Lyon - CRLCC
Lyon, France
Marseille - CRLCC
Marseille, France
Montpellier - ICM
Montpellier, France
Mulhouse - GHRMSA
Mulhouse, France
Paris - Curie
Paris, France
Paris - Saint-Louis
Paris, France
Paris - Tenon
Paris, France
Lyon - URCOT
Pierre-Bénite, France
Reims - CHU
Reims, France
Saint-Etienne - CHU
Saint-Etienne, France
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Toulouse - CHU
Toulouse, France
Tours - CHU
Tours, France
Valenciennes - Clinique
Valenciennes, France
Vandoeuvre-lès-Nancy - CRLCC
Vandœuvre-lès-Nancy, France
Villejuif - Gustave Roussy
Villejuif, France
Related Publications (2)
Girard N, Galland-Girodet S, Avrillon V, Besse B, Duruisseaux M, Cadranel J, Otto J, Prevost A, Roch B, Bennouna J, Bouledrak K, Coudurier M, Egenod T, Lamy R, Ricordel C, Moro-Sibilot D, Odier L, Tillon-Strozyk J, Zalcman G, Missy P, Westeel V, Baldacci S. Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study. ESMO Open. 2022 Apr;7(2):100418. doi: 10.1016/j.esmoop.2022.100418. Epub 2022 Feb 26.
PMID: 35227966RESULTBaldacci S, Besse B, Avrillon V, Mennecier B, Mazieres J, Dubray-Longeras P, Cortot AB, Descourt R, Doubre H, Quantin X, Duruisseaux M, Monnet I, Moro-Sibilot D, Cadranel J, Clement-Duchene C, Cousin S, Ricordel C, Merle P, Otto J, Schneider S, Langlais A, Morin F, Westeel V, Girard N. Lorlatinib for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer: Results of the IFCT-1803 LORLATU cohort. Eur J Cancer. 2022 May;166:51-59. doi: 10.1016/j.ejca.2022.01.018. Epub 2022 Mar 9.
PMID: 35278825RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Girard, MD, PhD
Institut Curie Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
November 1, 2018
Study Start
February 1, 2019
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share