NCT05167500

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Fundación GECP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-12-22
• Last updated: 2023-03-30

Locations

25 sites across 1 country: Spain