Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment (LORLAPULM)

March 29, 2023 updated by: Fundación GECP

Retrospective, Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain

This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended.

The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. In cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study.

Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.

The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.

Study Type

Observational

Enrollment (Actual)

118

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

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08028
        • Hospital Universitari Quiron Dexeus
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • León, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Madrid, Spain, 28922
        • Hospital Fundación de Alcorcón
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain, 46009
        • Hospital Universitari i Politècnic La Fe
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital Clínico Santiago
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
    • Cádiz
      • Cadiz, Cádiz, Spain, 11009
        • Hospital Puerta del Mar
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • A Coruña, La Coruña, Spain, 15009
        • Centro Oncologico de Galicia

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.

Description

Inclusion Criteria:

  • Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration.
  • Patients must have been treated with at least one cycle of lorlatinib within the compassionate use program.
  • Alive patients must have signed, dated the ethics committee approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

  • Alive patients who refuse to sign and date an ethics committee approved written informed consent form.
  • Patients who were accepted in the compassionate use program , but did not receive treatment.

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: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration.
Drug: Lorlatinib

No treatment will be administered to the patient as an active treatment of this study. Only retrospective data about the patients treated in the compassion use program of Lorlatinib will be collected. The information below is related to Lorlatinib, target drug for the collection of data.

Lorviqua 25 mg film-coated tablets.The recommended dose is 100 mg lorlatinib taken orally once daily. Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity. Dosing interruption or dose reduction may be required based on individual safety and tolerability.Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.

Other Names:
  • Lorviqua

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause.
From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Duration of the response
Time Frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Duration of the response defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause.
From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Time to treatment failure
Time Frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Time to treatment failure defined as time from the first dose of lorlatinib to the moment of discontinuation of treatment for any cause, including tumor progression, toxicity or death
From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival of ALK and ROS1 NSCLC patients
Time Frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Overall survival of ALK and ROS1 NSCLC patients from lorlatinib defined as time from the start of treatment until death or last follow-up
From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months

Collaborators and Investigators

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

Sponsor

Fundación GECP

Investigators

  • Study Chair: Antonio Calles, MD, Fundación GECP Investigator

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.

Helpful Links

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)

December 9, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 21/04_LORLAPULM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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