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

May 22, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • Aix-en-Provence - CH
      • Angers, France
        • Angers - CHU
      • Annemasse, France
        • Annemasse - CH
      • Avignon, France
        • Avignon - CH
      • Bordeaux, France
        • Bordeaux - Polyclinique
      • Brest, France
        • Brest - Morvan CHU
      • Cahors, France
        • Cahors - CH
      • Chartres, France
        • Chartres-CH
      • Clermont-Ferrand, France
        • Clermont-Ferrand - CHU
      • Colmar, France
        • Colmar - CH
      • Créteil, France
        • Créteil - CHI
      • La Roche-sur-Yon, France
        • La Roche-Sur-Yon - CH
      • Libourne, France
        • Libourne - CH
      • Lorient, France
        • Lorient - CHBS
      • Lyon, France
        • Lyon - CRLCC
      • Marseille, France
        • Marseille - CRLCC
      • Montpellier, France
        • Montpellier - ICM
      • Mulhouse, France
        • Mulhouse - GHRMSA
      • Paris, France
        • Paris - Curie
      • Paris, France
        • Paris - Saint-Louis
      • Paris, France
        • Paris - Tenon
      • Pierre-Bénite, France
        • Lyon - URCOT
      • Reims, France
        • Reims - CHU
      • Saint-Nazaire, France
        • Saint-Nazaire - Clinique Mutualiste de l'Estuaire
      • Saint-Étienne, France
        • Saint-Etienne - CHU
      • Toulouse, France
        • Toulouse - CHU
      • Tours, France
        • Tours - CHU
      • Valenciennes, France
        • Valenciennes - Clinique
      • Vandoeuvre-lès-Nancy, France
        • Vandoeuvre-lès-Nancy - CRLCC
      • Villejuif, France
        • Villejuif - Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
October 2015 - December 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
October 2015 - December 2019
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
October 2015 - December 2019
Pattern of tumor progression
Time Frame: October 2015 - December 2019
site of disease progression after each line of treatment
October 2015 - December 2019
Reason for treatment discontinuation
Time Frame: October 2015 - December 2019
this may be disease progression, toxicity, death, other
October 2015 - December 2019
Duration of treatment beyond progression
Time Frame: October 2015 - December 2019
time between first occurrence of disease progression and discontinuation the treatment
October 2015 - December 2019
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
October 2015 - December 2019
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
October 2015 - December 2019
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
October 2015 - December 2019
Adverse Events
Time Frame: October 2015 - December 2019
complications of lorlatinib therapy will be recorded
October 2015 - December 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Pfizer

Investigators

  • Principal Investigator: Nicolas Girard, MD, PhD, Institut Curie Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

October 12, 2020

Study Completion (Actual)

October 12, 2020

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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