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

Fundación GECP118 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Metastatic Non Small Cell Lung Cancer

Interventions

LorlatinibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Hospital Clínico Santiago

Santiago de Compostela, A Coruña, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months

Secondary Outcomes

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

Time frame: 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.

Time frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months

Data from ClinicalTrials.gov

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