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

Completed

• Conditions: Metastatic Non Small Cell Lung Cancer
• Interventions: Drug: Lorlatinib

• Registration Number: NCT05167500
• Lead Sponsor: Fundación 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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study Start: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

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 Clínico Santiago; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Puerta del Mar; 🇪🇸 Cadiz, Cádiz, Spain

Hospital Universitario Insular de Gran canaria; 🇪🇸 Las Palmas De Gran Canaria, Gran Canaria, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, La Coruña, Spain

Centro Oncológico de Galicia; 🇪🇸 A Coruña, La Coruña, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitari Quiron Dexeus; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

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