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

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ClinicalTrials.gov Identifier: NCT03727477
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

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.

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

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: October 2015 - December 2019 ]
    time from first dose of treatment to first occurrence of disease progression or death from any cause during the study


Secondary Outcome Measures :
  1. Best response [ Time Frame: October 2015 - December 2019 ]
    best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment

  2. Duration of treatment [ Time Frame: October 2015 - December 2019 ]
    time from first dose of treatment to discontinuation of treatment or death from any cause during the study

  3. Pattern of tumor progression [ Time Frame: October 2015 - December 2019 ]
    site of disease progression after each line of treatment

  4. Reason for treatment discontinuation [ Time Frame: October 2015 - December 2019 ]
    this may be disease progression, toxicity, death, other

  5. Duration of treatment beyond progression [ Time Frame: October 2015 - December 2019 ]
    time between first occurrence of disease progression and discontinuation the treatment

  6. Central Nervous System (CNS) best response [ Time Frame: October 2015 - December 2019 ]
    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

  7. Central Nervous System (CNS) Progression free survival [ Time Frame: October 2015 - December 2019 ]
    time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study

  8. Overall Survival [ Time Frame: October 2015 - December 2019 ]
    is defined as the time from the first dose of treatment dose and death from any cause

  9. Adverse Events [ Time Frame: October 2015 - December 2019 ]
    complications of lorlatinib therapy will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727477


Contacts
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Contact: Franck Morin, MSc 0033156811045 contact@ifct.fr
Contact: Pascale Missy, PhD 0033156811045 contact@ifct.fr

Locations
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France
Aix-en-Provence - CH Recruiting
Aix-en-Provence, France
Contact: Stéphanie MARTINEZ, Dr       contact@ifct.fr   
Angers - CHU Recruiting
Angers, France
Contact: José HUREAUX, Dr       contact@ifct.fr   
Avignon - CH Recruiting
Avignon, France
Contact: Nicolas CLOAREC, Dr       contact@ifct.fr   
Bordeaux - Polyclinique Recruiting
Bordeaux, France
Contact: Sigolène GALLAND-GIRODET, Dr       contact@ifct.fr   
Brest - Morvan CHU Recruiting
Brest, France
Contact: Renaud DESCOURT, Dr       contact@ifct.fr   
Cahors - CH Recruiting
Cahors, France
Contact: Patricia BARRE, Dr       contact@ifct.fr   
Chartres-CH Recruiting
Chartres, France
Contact: Hong RABUT, Dr       contact@ifct.fr   
Clermont-Ferrand - CHU Recruiting
Clermont-Ferrand, France
Contact: Patrick MERLE, Dr       contact@ifct.fr   
Colmar - CH Recruiting
Colmar, France
Contact: Lionel MOREAU, Dr       contact@ifct.fr   
Créteil - CHI Recruiting
Créteil, France
Contact: Isabelle MONNET, Dr       contact@ifct.fr   
La Roche-Sur-Yon - CH Recruiting
La Roche-sur-Yon, France
Contact: Marie MARCQ, Dr       contact@ifct.fr   
Libourne - CH Recruiting
Libourne, France
Contact: Laurent PORTEL, Dr       contact@ifct.fr   
Lorient - CHBS Recruiting
Lorient, France
Contact: Régine LAMY, Dr       contact@ifct.fr   
Lyon - CRLCC Recruiting
Lyon, France
Contact: Virginie AVRILLON, Dr       contact@ifct.fr   
Marseille - CRLCC Recruiting
Marseille, France
Contact: Anne MADROSZYK, Dr       contact@ifct.fr   
Montpellier - ICM Recruiting
Montpellier, France
Contact: Catherine BECHT, Dr       contact@ifct.fr   
Mulhouse - GHRMSA Recruiting
Mulhouse, France
Contact: Didier DEBIEUVRE, Dr       contact@ifct.fr   
Paris - Curie Recruiting
Paris, France
Contact: Nicolas GIRARD, Pr       contact@ifct.fr   
Paris - Saint-Louis Recruiting
Paris, France
Contact: Ludovic DOUCET, Dr       contact@ifct.fr   
Paris - Tenon Recruiting
Paris, France
Contact: Jacques CADRANEL, Pr       contact@ifct.fr   
Lyon - URCOT Recruiting
Pierre-Bénite, France
Contact: Michaël DURUISSEAUX, Dr       contact@ifct.fr   
Reims - CHU Recruiting
Reims, France
Contact: Maxime DEWOLF, Dr       contact@ifct.fr   
Saint-Nazaire - Clinique Mutualiste de l'Estuaire Recruiting
Saint-Nazaire, France
Contact: Thierry CHATELLIER, Dr       contact@ifct.fr   
Saint-Etienne - CHU Recruiting
Saint-Étienne, France
Contact: Claire TISSOT FILIPPELLO, Dr       contact@ifct.fr   
Toulouse - CHU Recruiting
Toulouse, France
Contact: Julien MAZIERES, Pr         
Contact       contact@ifct.fr   
Tours - CHU Recruiting
Tours, France
Contact: Eric PICHON       contact@ifct.fr   
Valenciennes - Clinique Recruiting
Valenciennes, France
Contact: Thomas GEY, Dr       contact@ifct.fr   
Vandoeuvre-lès-Nancy - CRLCC Recruiting
Vandoeuvre-lès-Nancy, France
Contact: Christelle CLEMENT-DUCHENE       contact@ifct.fr   
Villejuif - Gustave Roussy Recruiting
Villejuif, France
Contact: Benjamin BESSE, Pr       contact@ifct.fr   
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Pfizer
Investigators
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Principal Investigator: Nicolas Girard, MD, PhD Institut Curie Paris

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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT03727477     History of Changes
Other Study ID Numbers: IFCT-1803
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
lorlatinib
Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms