Spots Global Cancer Trial Database for Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

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Trial Identification

Brief Title: Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

Official Title: 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

Study ID: NCT05167500

Conditions

Metastatic Non Small Cell Lung Cancer

Interventions

Lorlatinib

Study Description

Brief 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.

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.