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

NCT05167500 | Completed

• 1 other identifier: GECP 21/04_LORLAPULM
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 25

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.

Conditions

Metastatic Non Small Cell Lung Cancer

Keywords

Lung Diseases; Non small cell lung cancer; Metastatic disease; Lorlatinib; ALK alteration; ROS1 alteration

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

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.

Also known as: Lorviqua

Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (25)

Hospital Clínico Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, La Coruña, 15009, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, 08028, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario de Jaén

Jaén, 23007, Spain

Location

Complejo Asistencial Universitario de León

León, 24071, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Fundación de Alcorcón

Madrid, 28922, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Complejo Hospitalario de Toledo

Toledo, 45004, Spain

Location

Hospital Universitari i Politécnic La Fe

Valencia, 46009, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Diseases; Neoplasm Metastasis

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Calles, MD

  Fundación GECP Investigator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 22, 2021
• Study Start: December 9, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (25)