Clinical trial NCT05167500: Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Non Small Cell Lung Cancer
Keywords: Lung Diseases
Non small cell lung cancer
Metastatic disease
Lorlatinib
ALK alteration
ROS1 alteration
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
measure: Duration of the response
timeFrame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
measure: Time to treatment failure
timeFrame: 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:
measure: Overall survival of ALK and ROS1 NSCLC patients
timeFrame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
state: Cádiz
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran canaria
state: Gran Canaria
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: La Coruña
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: La Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Fundación de Alcorcón
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Fundación GECP Investigator
name: Antonio Calles, MD
role: STUDY_CHAIR
References: