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

Sponsor
Fundación GECP (Other)
Overall Status
Recruiting
CT.gov ID
NCT05167500
Collaborator
(none)
145
Enrollment
25
Locations
8.7
Anticipated Duration (Months)
5.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
145 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • Lorviqua

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico Santiago Santiago De Compostela A Coruña Spain 15706
    2 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
    3 Hospital Germans Trias i Pujol Badalona Barcelona Spain 08916
    4 Hospital Puerta del Mar Cadiz Cádiz Spain 11009
    5 Hospital Universitario Insular de Gran canaria Las Palmas De Gran Canaria Gran Canaria Spain 35016
    6 Complejo Hospitalario Universitario A Coruña A Coruña La Coruña Spain 15006
    7 Centro Oncológico de Galicia A Coruña La Coruña Spain 15009
    8 Hospital del Mar Barcelona Spain 08003
    9 Hospital Universitari Quiron Dexeus Barcelona Spain 08028
    10 Hospital Clinic de Barcelona Barcelona Spain 08036
    11 Hospital Universitario de Burgos Burgos Spain 09006
    12 Hospital Dr. Josep Trueta Girona Spain 17007
    13 Hospital Universitario de Jaén Jaén Spain 23007
    14 Complejo Asistencial Universitario de León León Spain 24071
    15 Hospital Gregorio Marañón Madrid Spain 28007
    16 Hospital Clínico San Carlos Madrid Spain 28040
    17 Hospital 12 De Octubre Madrid Spain 28041
    18 Hospital Puerta de Hierro Madrid Spain 28222
    19 Hospital Fundación de Alcorcón Madrid Spain 28922
    20 Hospital Virgen del Rocio Sevilla Spain 41013
    21 Complejo Hospitalario de Toledo Toledo Spain 45004
    22 Hospital Universitari i Politécnic La Fe Valencia Spain 46009
    23 Hospital Clínico de Valencia Valencia Spain 46010
    24 Hospital General de Valencia Valencia Spain 46014
    25 Hospital Clínico Lozano Blesa Zaragoza Spain 50009

    Sponsors and Collaborators

    • Fundación GECP

    Investigators

    • Study Chair: Antonio Calles, MD, Fundación GECP Investigator

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Fundación GECP
    ClinicalTrials.gov Identifier:
    NCT05167500
    Other Study ID Numbers:
    • GECP 21/04_LORLAPULM
    First Posted:
    Dec 22, 2021
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundación GECP
    Lung Diseases
    Non small cell lung cancer
    Metastatic disease
    Lorlatinib
    ALK alteration
    ROS1 alteration
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jun 2, 2022