Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
GECP 21/04_LORLAPULM
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. 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.
Trial arms
Trial start
2021-12-09
Estimated PCD
2022-12-30
Trial end
2022-12-30
Status
Completed
Treatment
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.
Arms:
Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient
Other names:
Lorviqua
Size
118
Primary endpoint
Progression-free survival
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
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
From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 118, 'type': 'ACTUAL'}}
Updated at
2023-03-30

1 organization

1 product

1 indication

Organization
Fundación GECP
Product
Lorlatinib
Indication
Metastatic Non Small Cell Lung Cancer