Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib

Non-small Cell Lung Cancer Metastatic Clinical Trial

— LORLATU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727477
• Other study ID #: IFCT-1803
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: October 12, 2020

Study information

• Verified date: May 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK Gene Rearrangement Positive
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• ROS-1 Gene Rearrangement Positive

Locations

Country	Name	City	State
France	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-Étienne
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	Vandoeuvre-lès-Nancy
France	Villejuif - Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	Pfizer

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Best response	best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment	October 2015 - December 2019
Secondary	Duration of treatment	time from first dose of treatment to discontinuation of treatment or death from any cause during the study	October 2015 - December 2019
Secondary	Pattern of tumor progression	site of disease progression after each line of treatment	October 2015 - December 2019
Secondary	Reason for treatment discontinuation	this may be disease progression, toxicity, death, other	October 2015 - December 2019
Secondary	Duration of treatment beyond progression	time between first occurrence of disease progression and discontinuation the treatment	October 2015 - December 2019
Secondary	Central Nervous System (CNS) best response	in patients with CNS measurable lesion, best response on CNS locations recorded from the start of treatment until disease progression or start of further anti-cancer treatment	October 2015 - December 2019
Secondary	Central Nervous System (CNS) Progression free survival	time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study	October 2015 - December 2019
Secondary	Overall Survival	is defined as the time from the first dose of treatment dose and death from any cause	October 2015 - December 2019
Secondary	Adverse Events	complications of lorlatinib therapy will be recorded	October 2015 - December 2019