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

NCT ID: NCT03727477

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-10-12

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer Metastatic ALK Gene Rearrangement Positive ROS-1 Gene Rearrangement Positive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Girard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Paris

Locations

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Aix-en-Provence - CH

Aix-en-Provence, , France

Site Status

Angers - CHU

Angers, , France

Site Status

Annemasse - CH

Annemasse, , France

Site Status

Avignon - CH

Avignon, , France

Site Status

Bordeaux - Polyclinique

Bordeaux, , France

Site Status

Brest - Morvan CHU

Brest, , France

Site Status

Cahors - CH

Cahors, , France

Site Status

Chartres-CH

Chartres, , France

Site Status

Clermont-Ferrand - CHU

Clermont-Ferrand, , France

Site Status

Colmar - CH

Colmar, , France

Site Status

Créteil - CHI

Créteil, , France

Site Status

La Roche-Sur-Yon - CH

La Roche-sur-Yon, , France

Site Status

Libourne - CH

Libourne, , France

Site Status

Lorient - CHBS

Lorient, , France

Site Status

Lyon - CRLCC

Lyon, , France

Site Status

Marseille - CRLCC

Marseille, , France

Site Status

Montpellier - ICM

Montpellier, , France

Site Status

Mulhouse - GHRMSA

Mulhouse, , France

Site Status

Paris - Curie

Paris, , France

Site Status

Paris - Saint-Louis

Paris, , France

Site Status

Paris - Tenon

Paris, , France

Site Status

Lyon - URCOT

Pierre-Bénite, , France

Site Status

Reims - CHU

Reims, , France

Site Status

Saint-Etienne - CHU

Saint-Etienne, , France

Site Status

Saint-Nazaire - Clinique Mutualiste de l'Estuaire

Saint-Nazaire, , France

Site Status

Toulouse - CHU

Toulouse, , France

Site Status

Tours - CHU

Tours, , France

Site Status

Valenciennes - Clinique

Valenciennes, , France

Site Status

Vandoeuvre-lès-Nancy - CRLCC

Vandœuvre-lès-Nancy, , France

Site Status

Villejuif - Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35227966 (View on PubMed)

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.

Reference Type RESULT
PMID: 35278825 (View on PubMed)

Other Identifiers

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IFCT-1803

Identifier Type: -

Identifier Source: org_study_id

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