Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment
- Registration Number
- NCT05167500
- Lead Sponsor
- Fundaci贸n GECP
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient Lorlatinib 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.
- Primary Outcome Measures
Name Time Method Progression-free survival 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 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 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 Outcome Measures
Name Time Method 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 Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
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 Overall survival of ALK and ROS1 NSCLC patients from lorlatinib defined as time from the start of treatment until death or last follow-up
Trial Locations
- Locations (25)
Hospital Germans Trias i Pujol
馃嚜馃嚫Badalona, Barcelona, Spain
Hospital 12 De Octubre
馃嚜馃嚫Madrid, Spain
Hospital Cl铆nico Santiago
馃嚜馃嚫Santiago De Compostela, A Coru帽a, Spain
Hospital Universitario Central de Asturias
馃嚜馃嚫Oviedo, Asturias, Spain
Hospital Puerta del Mar
馃嚜馃嚫Cadiz, C谩diz, Spain
Hospital Universitario Insular de Gran canaria
馃嚜馃嚫Las Palmas De Gran Canaria, Gran Canaria, Spain
Complejo Hospitalario Universitario A Coru帽a
馃嚜馃嚫A Coru帽a, La Coru帽a, Spain
Centro Oncol贸gico de Galicia
馃嚜馃嚫A Coru帽a, La Coru帽a, Spain
Hospital del Mar
馃嚜馃嚫Barcelona, Spain
Hospital Universitari Quiron Dexeus
馃嚜馃嚫Barcelona, Spain
Hospital Clinic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital Universitario de Burgos
馃嚜馃嚫Burgos, Spain
Hospital Universitario de Ja茅n
馃嚜馃嚫Ja茅n, Spain
Hospital Dr. Josep Trueta
馃嚜馃嚫Girona, Spain
Complejo Asistencial Universitario de Le贸n
馃嚜馃嚫Le贸n, Spain
Hospital Gregorio Mara帽贸n
馃嚜馃嚫Madrid, Spain
Hospital Cl铆nico San Carlos
馃嚜馃嚫Madrid, Spain
Hospital Puerta de Hierro
馃嚜馃嚫Madrid, Spain
Hospital Fundaci贸n de Alcorc贸n
馃嚜馃嚫Madrid, Spain
Complejo Hospitalario de Toledo
馃嚜馃嚫Toledo, Spain
Hospital Virgen del Rocio
馃嚜馃嚫Sevilla, Spain
Hospital Universitari i Polit茅cnic La Fe
馃嚜馃嚫Valencia, Spain
Hospital Cl铆nico de Valencia
馃嚜馃嚫Valencia, Spain
Hospital General de Valencia
馃嚜馃嚫Valencia, Spain
Hospital Cl铆nico Lozano Blesa
馃嚜馃嚫Zaragoza, Spain