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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05167500
Other study ID # GECP 21/04_LORLAPULM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 9, 2021
Est. completion date December 30, 2022

Study information

Verified date March 2023
Source Fundación GECP
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Centro Oncológico de Galicia A Coruña La Coruña
Spain Complejo Hospitalario Universitario A Coruña A Coruña La Coruña
Spain Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitari Quiron Dexeus Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Puerta del Mar Cadiz Cádiz
Spain Hospital Dr. Josep Trueta Girona
Spain Hospital Universitario de Jaén Jaén
Spain Hospital Universitario Insular de Gran canaria Las Palmas De Gran Canaria Gran Canaria
Spain Complejo Asistencial Universitario de León León
Spain Hospital 12 De Octubre Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Fundación de Alcorcón Madrid
Spain Hospital Gregorio Marañón Madrid
Spain Hospital Puerta de Hierro Madrid
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Clínico Santiago Santiago De Compostela A Coruña
Spain Hospital Virgen del Rocio Sevilla
Spain Complejo Hospitalario de Toledo Toledo
Spain Hospital Clínico de Valencia Valencia
Spain Hospital General de Valencia Valencia
Spain Hospital Universitari i Politécnic La Fe Valencia
Spain Hospital Clínico Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival 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
Primary Duration of the response 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
Primary Time to treatment failure 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 Overall survival of ALK and ROS1 NSCLC patients 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
Secondary Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) 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
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