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

Metastatic Non Small Cell Lung Cancer Clinical Trial

— LORLAPULM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167500
• Other study ID #: GECP 21/04_LORLAPULM
• Status: Completed
• Start date: December 9, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Fundación GECP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non Small Cell Lung Cancer

Intervention

Drug:
• Lorlatinib
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.

Locations

Country	Name	City	State
Spain	Centro Oncológico de Galicia	A Coruña	La Coruña
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña	La Coruña
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Quiron Dexeus	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Puerta del Mar	Cadiz	Cádiz
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital Universitario Insular de Gran canaria	Las Palmas De Gran Canaria	Gran Canaria
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital 12 De Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Fundación de Alcorcón	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Clínico Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital Universitari i Politécnic La Fe	Valencia
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   Web page of the sponsor where users can find more information about Fundacion GECP studies