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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metastatic Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Lorlatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient<br>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<br>* 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.<br>* Other names: Lorviqua;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Diseases, Non small cell lung cancer, Metastatic disease, Lorlatinib, ALK alteration, ROS1 alteration