Clinical trial NCT03727477: Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
Official title: Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Metastatic
ALK Gene Rearrangement Positive
ROS-1 Gene Rearrangement Positive
Keywords: lorlatinib
Non-small Cell Lung Cancer
IFCT
Real-world study
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-11-01
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Detailed description: IFCT-1803 LORLATU 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 (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients enrolled in a lorlatinib clinical trial

Primary outcomes:
measure: Progression free survival
timeFrame: October 2015 - December 2019
Secondary outcomes:
measure: Best response
timeFrame: October 2015 - December 2019
measure: Duration of treatment
timeFrame: October 2015 - December 2019
measure: Pattern of tumor progression
timeFrame: October 2015 - December 2019
measure: Reason for treatment discontinuation
timeFrame: October 2015 - December 2019
measure: Duration of treatment beyond progression
timeFrame: October 2015 - December 2019
measure: Central Nervous System (CNS) best response
timeFrame: October 2015 - December 2019
measure: Central Nervous System (CNS) Progression free survival
timeFrame: October 2015 - December 2019
measure: Overall Survival
timeFrame: October 2015 - December 2019
measure: Adverse Events
timeFrame: October 2015 - December 2019
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Aix-en-Provence - CH
city: Angers
country: France
facility: Angers - CHU
city: Annemasse
country: France
facility: Annemasse - CH
city: Avignon
country: France
facility: Avignon - CH
city: Bordeaux
country: France
facility: Bordeaux - Polyclinique
city: Brest
country: France
facility: Brest - Morvan CHU
city: Cahors
country: France
facility: Cahors - CH
city: Chartres
country: France
facility: Chartres-CH
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand - CHU
city: Colmar
country: France
facility: Colmar - CH
city: Créteil
country: France
facility: Créteil - CHI
city: La Roche-sur-Yon
country: France
facility: La Roche-Sur-Yon - CH
city: Libourne
country: France
facility: Libourne - CH
city: Lorient
country: France
facility: Lorient - CHBS
city: Lyon
country: France
facility: Lyon - CRLCC
city: Marseille
country: France
facility: Marseille - CRLCC
city: Montpellier
country: France
facility: Montpellier - ICM
city: Mulhouse
country: France
facility: Mulhouse - GHRMSA
city: Paris
country: France
facility: Paris - Curie
city: Paris
country: France
facility: Paris - Saint-Louis
city: Paris
country: France
facility: Paris - Tenon
city: Pierre-Bénite
country: France
facility: Lyon - URCOT
city: Reims
country: France
facility: Reims - CHU
city: Saint-Nazaire
country: France
facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire
city: Saint-Étienne
country: France
facility: Saint-Etienne - CHU
city: Toulouse
country: France
facility: Toulouse - CHU
city: Tours
country: France
facility: Tours - CHU
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Vandoeuvre-lès-Nancy
country: France
facility: Vandoeuvre-lès-Nancy - CRLCC
city: Villejuif
country: France
facility: Villejuif - Gustave Roussy
Study officials:
affiliation: Institut Curie Paris
name: Nicolas Girard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Baldacci 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.