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
Overview
- Phase
- Not Applicable
- Intervention
- Lorlatinib
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Sponsor
- Fundación GECP
- Enrollment
- 118
- Locations
- 25
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient
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.
Intervention: Lorlatinib
Outcomes
Primary Outcomes
Progression-free survival
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
Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause.
Duration of the response
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 defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause.
Time to treatment failure
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 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
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months)
- Overall survival of ALK and ROS1 NSCLC patients(From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months)